HDL-CNCT05174663
Investigating the Dose Response of an Almond-enriched Diet on Optimizing HDL-C in a Population With Hypercholesterolemia
A study testing Almond-enriched diet - 1.5 oz and Almond-enriched diet - 2.5 oz in people with HDL-C and Hypercholesterolemia, run by Almond Board of California at 1 site in Canada.
Trial summary
This study will determine the quantity of almonds (1.5 oz or 2.5 oz) consumed as a snack that will provide optimal increases in HDL-C levels. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- HDL-C, Hypercholesterolemia
- What is being tested?
- Almond-enriched diet - 1.5 oz and Almond-enriched diet - 2.5 oz
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteCanada
- Study dates
- 10 Jan 2022to 18 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and Females between 30-65 years of age, inclusive
- BMI between 25.0 - 34.9 kg/m2, inclusive
- Individual is not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening
- Or,
- Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
- Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
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- Double-barrier method
- Intrauterine devices
- Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
- Vasectomy of partner at least 6 months prior to screening
- Individuals with hypercholesterolemia based on the NCEP definition (LDL-C levels >4.1 mmol/L (>160 mg/dL))
- Motivated to comply with dietary guidelines as assessed by a motivation questionnaire at screening
- Self-reported stable body weight for the past 3 months defined as not having gained or lost more than 5 kg of body weight throughout the 3 months prior to baseline
- Agrees to adhere to dietary guidelines and to maintain current lifestyle habits as much as possible throughout the study depending on the participants' ability to maintain the following: medications, supplements, exercise, and sleep and avoid taking new supplements
- Provided voluntary, written, informed consent to participate in the study
- Healthy as determined by medical history, and laboratory results exam as assessed by Qualified Investigator (QI)
Who cannot join
- Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
- Allergy, sensitivity, or intolerance to the investigational product/control snack ingredients
- Current regular consumption of nuts >2 times per week, unless willing to washout prior to baseline
- Current use of prescribed lipid lowering medications as assessed by QI (see Section 7.3.1)
- Current use of over-the-counter medications or supplements known to affect blood lipid levels (i.e. omega-3) or vitamin E status
- Unstable metabolic disease or chronic diseases as assessed by the QI
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- Current or history of any significant diseases of the gastrointestinal tract as assessed by QI
- Type I or Type II diabetes
- Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
- Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis
- Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI
- Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
- Individuals with an autoimmune disease or are immune compromised as assessed by QI
- Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis
- Self-reported confirmation of blood/bleeding disorders as assessed by QI
- Use of tobacco products within 12 weeks of baseline and during the study period as assessed by QI
- Alcohol intake average of >2 standard drinks per day as assessed by the QI
- Alcohol or drug abuse within the last 12 months
- Clinically significant abnormal laboratory results at screening as assessed by the QI
- Individuals who are unable to give informed consent
- Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Comparator-controlled Parallel Study to Investigate the Dose Response of an Almond-enriched Diet on Optimizing HDL-C in a Population With Hypercholesterolemia
This study will determine the quantity of almonds (1.5 oz or 2.5 oz) consumed as a snack that will provide optimal increases in HDL-C levels.
Read the detailed description
Elevated lipid levels are a major modifiable risk factor for cardiovascular disease (CVD), which is the leading cause of death worldwide, accounting for over 17.8 million deaths globally, equating to approximately 71 million Americans with the total annual cost associated with CVD approximating $351.3 billion USD. The National Cholesterol Education Program (NCEP) ATP III Guidelines and supporting literature recommend diet and lifestyle approaches for patients with elevated lipid levels prior to lipid lowering medication, as changing lifestyle and diet cost less than medications and does not lead to polypharmacy or unwanted side effects. Low nut and seed consumption has been identified as the leading dietary risk factor attributed to ischemic heart disease. Indeed, studies have demonstrated that almond consumption reduces total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and triglyceride (TG) levels compared to no almond controls or substitutions. Additionally, emerging and predictive CVD risk factors such as abdominal obesity and concentrations of Apolipoprotein (ApoB), for which a dose-response effect may also be present, are also improved by almond consumption.
While the benefits of an almond-rich diet on TC, TG, and LDL-C are clear, the effects of almonds on high-density lipoprotein cholesterol (HDL-C) levels is less clear. In populations with hyperlipidemia, almond consumption appears to improve HDL-C, among other lipid markers. Yet, a recent systematic-review and meta-analysis reported a significant decrease in HDL-C compared to control across 12 studies. It is possible that a dose-response relationship exists for almond consumption and HDL-C levels. Almond consumption of ≤42.5 g/day significantly decreased LDL-C/HDL-C, TC/HDL-C and ApoB compared to control, however, significant reductions in TC, BP and body weight were only observed with >42.5 g of almonds/day. Sabate et al., found that the NCEP Step I Diet as well as a low almond diet (10% from calories) significantly reduced HDL-C by 3% and 4%, respectively. However, a high almond-diet (20% from calories) maintained HDL-C levels, while having favorable changes on LDL-C, LDL-C/HDL-C and ApoB/ApoA . Daily almond consumption between 37-73 g/day (~1.3-2.5 oz/day) resulted in significantly higher HDL-C levels compared to a muffin control, with the higher dose of almonds (73 g/day) resulting in a greater increase in HDL-C compared to a lower dose (37 g/day). Additionally, the majority of studies are of limited length and often less than 12 weeks long. A previous study on the long term effects of almonds and other lipid-modulating foods found the greatest reductions on LDL-C and TC/HDL-C were not observed until 12 weeks, and then maintained. Further, it has been suggested that other outcomes such as BP, body weight and abdominal obesity may require longer term consumption of almonds to show beneficial changes. Therefore, it is likely heterogeneity in the effect of HDL-C levels with almond consumption is due to inadequate study duration, background diet, population, control used or too low quantity of almonds.
The existing FDA health claim for almonds states: "scientific evidence suggests, but does not prove, that eating 1.5 ounces per day of most nuts, such as almonds, as part of a diet low in saturated fat and cholesterol may reduce the risk of heart disease". Despite the benefits of almonds on cardiometabolic health, clinical trials designed to determine the optimal dose of almonds on the improvement of lipid profile in a population at greater risk of CVD have not been conducted. This study will address this research gap and establish the optimal dose of almonds for improving HDL-C and other CVD markers and ultimately lowering risk in a population at increased risk of disease development. The specific aim of this study is to demonstrate the efficacy of consuming increasing quantities of almonds on blood lipid levels in adults with hypercholesterolemia. Two doses of almonds will be used, 1.5 oz and 2.5 oz, referred to the Almond-enriched Diet Dose 1 (AD1) and Almond-enriched Diet Dose 2 (AD2), respectively, compared to a Nut-Free Diet (NFD). This study will determine the optimal quantity of almonds consumed as a snack that will provide the most clinically relevant increase of HDL-C levels. Further, this study will investigate the dose-response of almonds on other lipid profile markers, blood pressure (BP), weight, and markers of abdominal obesity in a population with hypercholesterolemia. The hypothesis is that there will be an improvement in HDL-C in a dose-dependent manner with increased consumption of almonds for 16 weeks.
Participants in this study represent a target population that aligns with the goals of healthcare to provide lifestyle management prior to the introduction of prescription medication plans. The study is to be conducted in a population at risk of developing heart disease, who have hypercholesterolemia based on the NCEP definition (LDL-C levels >4.1 mmol/L (>160 mg/dL)). Currently, approximately 53% of the North American population is considered to have elevated LDL-C levels, yet less than half receive treatment. Participants aged 30 to 65 years will be considered for enrolment to avoid complications related to advanced age and a body mass index (BMI) of and up to 34.9 kg/m2 will eliminate confounders related to advanced obesity. Significant metabolic or physiological conditions that may affect lipid levels will be excluded and any participants on prescribed lipid lowering medication will be excluded to limit confounders. Current use of supplements known to affect blood lipid levels, vitamin E status or tree nuts that may impact study outcomes will be excluded unless participants undergo an appropriate washout period prior to enrollment. As well, an extensive list of exclusions in place will ensure that eligibility is based on establishing health and each participants' eligibility will be overseen by the Qualified Investigator (QI).
- Conditions
- HDL-C, Hypercholesterolemia
- Being tested
- Almond-enriched diet - 1.5 oz, Almond-enriched diet - 2.5 oz, Control snack
- Keywords
- Hypercholesterolemia, HDL-C, Almond-enriched diet
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Almond-enriched diet - 1.5 ozOther
Participants will receive 1.5 oz of almonds consumed as a snack daily for 16 weeks.
Almond-enriched diet - 2.5 ozOther
Participants will receive 2.5 oz of almonds consumed as a snack daily for 16 weeks.
Control snackOther
Participants will receive a control snack daily for 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Almond-enriched diet dose 1 | Experimental | Participants will be instructed to ingest 1.5 oz of almonds daily for 16 weeks. The 1.5 oz of almonds can be split into a morning and afternoon snack. Participants will be advised not to exceed 2 doses of almonds daily. If a dose is missed, participants should take the missed dose as soon as the participants remember. Receives: Other: Almond-enriched diet - 1.5 oz |
| Almond-enriched diet dose 2 | Experimental | Participants will be instructed to ingest 2.5 oz of almonds daily for 16 weeks. The 2.5 oz of almonds can be split into a morning and afternoon snack. Participants will be advised not to exceed 2 doses of almonds daily. If a dose is missed, participants should take the missed dose as soon as the participants remember. Receives: Other: Almond-enriched diet - 2.5 oz |
| Nut-free diet | Other | Participants will be instructed to ingest the control snack (Iso-caloric [to 1.5 oz of almonds] control snack of chocolate chip cookies or Oreo cookies) daily for 16 weeks. The control snack can be split into a morning and afternoon snack. Participants will be advised not to exceed 2 doses of snack daily. If a dose is missed, participants should take the missed dose as soon as the participants remember. Receives: Other: Control snack |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to week 16 in HDL-C levels between the Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2, and Nut-Free Diet
The change from baseline in HDL-C levels at week 16 between Almond-enriched Diet Dose 1 (AD1), Almond-Enriched Diet Dose 2 (AD2), and Nut-Free Diet (NFD) will be determined.
Measured: 16 weeks
Secondary outcomes (77)
Change from baseline to week 4 in HDL-C levels between the Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2, and Nut-Free Diet
The change from baseline in HDL-C levels at week 4 between Almond-enriched Diet Dose 1 (AD1), Almond-Enriched Diet Dose 2 (AD2), and Nut-Free Diet (NFD) will be determined.
Measured: 4 weeks
Change from baseline to week 8 in HDL-C levels between the Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2, and Nut-Free Diet
The change from baseline in HDL-C levels at week 8 between Almond-enriched Diet Dose 1 (AD1), Almond-Enriched Diet Dose 2 (AD2), and Nut-Free Diet (NFD) will be determined.
Measured: 8 weeks
Change from baseline to week 12 in HDL-C levels between the Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2, and Nut-Free Diet
The change from baseline in HDL-C levels at week 12 between Almond-enriched Diet Dose 1 (AD1), Almond-Enriched Diet Dose 2 (AD2), and Nut-Free Diet (NFD) will be determined.
Measured: 12 weeks
The difference in the proportion of participants from baseline to 4 weeks achieving a clinically relevant increase in HDL-C levels
The difference in the proportion of participants from baseline to 4 weeks achieving a clinically relevant increase in HDL-C levels defined as an increase of at least 1 mg/dL (0.026 mmol/L) will be determined.
Measured: 4 weeks
The difference in the proportion of participants from baseline to 8 weeks achieving a clinically relevant increase in HDL-C levels
The difference in the proportion of participants from baseline to 8 weeks achieving a clinically relevant increase in HDL-C levels defined as an increase of at least 1 mg/dL (0.026 mmol/L) will be determined.
Measured: 8 weeks
The difference in the proportion of participants from baseline to 12 weeks achieving a clinically relevant increase in HDL-C levels
The difference in the proportion of participants from baseline to 12 weeks achieving a clinically relevant increase in HDL-C levels defined as an increase of at least 1 mg/dL (0.026 mmol/L) will be determined.
Measured: 12 weeks
The difference in the proportion of participants from baseline to 16 weeks achieving a clinically relevant increase in HDL-C levels
The difference in the proportion of participants from baseline to 16 weeks achieving a clinically relevant increase in HDL-C levels defined as an increase of at least 1 mg/dL (0.026 mmol/L) will be determined.
Measured: 16 weeks
The difference in the proportion of participants from baseline to 16 weeks achieving no change or an increase in HDL-C levels
The difference in the proportion of participants from baseline to 16 weeks achieving no change or an increase in HDL-C levels based on expected effects through almond intervention will be determined.
Measured: 16 weeks
The difference in the proportion of participants from baseline to 4 weeks achieving no change or an increase in HDL-C levels
The difference in the proportion of participants from baseline to 4 weeks achieving no change or an increase in HDL-C levels based on expected effects through almond intervention will be determined.
Measured: 4 weeks
The difference in the proportion of participants from baseline to 8 weeks achieving no change or an increase in HDL-C levels
The difference in the proportion of participants from baseline to 8 weeks achieving no change or an increase in HDL-C levels based on expected effects through almond intervention will be determined.
Measured: 8 weeks
The difference in the proportion of participants from baseline to 12 weeks achieving no change or an increase in HDL-C levels
The difference in the proportion of participants from baseline to 12 weeks achieving no change or an increase in HDL-C levels based on expected effects through almond intervention will be determined.
Measured: 12 weeks
The difference in the proportion of participants from baseline to 4 weeks achieving movement from HDL-C categories
The difference in the proportion of participants from baseline to 4 weeks achieving movement from HDL-C categories defined by NCEP guidelines (those with HDL-C levels <40 mg/dL (1.04 mmol/L) and ≥40 mg/dL) will be determined.
Measured: 4 weeks
The difference in the proportion of participants from baseline to 8 weeks achieving movement from HDL-C categories
The difference in the proportion of participants from baseline to 8 weeks achieving movement from HDL-C categories defined by NCEP guidelines (those with HDL-C levels <40 mg/dL (1.04 mmol/L) and ≥40 mg/dL) will be determined.
Measured: 8 weeks
The difference in the proportion of participants from baseline to 12 weeks achieving movement from HDL-C categories
The difference in the proportion of participants from baseline to 12 weeks achieving movement from HDL-C categories defined by NCEP guidelines (those with HDL-C levels <40 mg/dL (1.04 mmol/L) and ≥40 mg/dL) will be determined.
Measured: 12 weeks
The difference in the proportion of participants from baseline to 16 weeks achieving movement from HDL-C categories
The difference in the proportion of participants from baseline to 16 weeks achieving movement from HDL-C categories defined by NCEP guidelines (those with HDL-C levels <40 mg/dL (1.04 mmol/L) and ≥40 mg/dL) will be determined.
Measured: 16 weeks
The difference in the proportion of participants from baseline to 16 weeks achieving a change in total cholesterol levels
The difference in the proportion of participants from baseline to 16 weeks achieving a change in total cholesterol levels will be determined.
Measured: 16 weeks
The difference in the proportion of participants from baseline to 4 weeks achieving a change in total cholesterol levels
The difference in the proportion of participants from baseline to 4 weeks achieving a change in total cholesterol levels will be determined.
Measured: 4 weeks
The difference in the proportion of participants from baseline to 8 weeks achieving a change in total cholesterol levels
The difference in the proportion of participants from baseline to 8 weeks achieving a change in total cholesterol levels will be determined.
Measured: 8 weeks
The difference in the proportion of participants from baseline to 12 weeks achieving a change in total cholesterol levels
The difference in the proportion of participants from baseline to 12 weeks achieving a change in total cholesterol levels will be determined.
Measured: 12 weeks
The difference in the proportion of participants from baseline to 4 weeks achieving a change in LDL-C levels
The difference in the proportion of participants from baseline to 4 weeks achieving a change in LDL-C levels will be determined.
Measured: 4 weeks
The difference in the proportion of participants from baseline to 12 weeks achieving a change in LDL-C levels
The difference in the proportion of participants from baseline to 12 weeks achieving a change in LDL-C levels will be determined.
Measured: 12 weeks
The difference in the proportion of participants from baseline to 16 weeks achieving a change in LDL-C levels
The difference in the proportion of participants from baseline to 16 weeks achieving a change in LDL-C levels will be determined.
Measured: 16 weeks
The difference in the proportion of participants from baseline to 8 weeks achieving a change in LDL-C levels
The difference in the proportion of participants from baseline to 8 weeks achieving a change in LDL-C levels will be determined.
Measured: 8 weeks
The difference in the proportion of participants from baseline to 4 weeks achieving a change in triglyceride levels
The difference in the proportion of participants from baseline to 4 weeks achieving a change in triglyceride levels will be determined.
Measured: 4 weeks
The difference in the proportion of participants from baseline to 8 weeks achieving a change in triglyceride levels
The difference in the proportion of participants from baseline to 8 weeks achieving a change in triglyceride levels will be determined.
Measured: 8 weeks
The difference in the proportion of participants from baseline to 12 weeks achieving a change in triglyceride levels
The difference in the proportion of participants from baseline to 12 weeks achieving a change in triglyceride levels will be determined.
Measured: 12 weeks
The difference in the proportion of participants from baseline to 16 weeks achieving a change in triglyceride levels
The difference in the proportion of participants from baseline to 16 weeks achieving a change in triglyceride levels will be determined.
Measured: 16 weeks
The difference in the proportion of participants from baseline to 4 weeks achieving a change in non-HDL-C levels
The difference in the proportion of participants from baseline to 4 weeks achieving a change in non-HDL-C levels will be determined.
Measured: 4 weeks
The difference in the proportion of participants from baseline to 8 weeks achieving a change in non-HDL-C levels
The difference in the proportion of participants from baseline to 8 weeks achieving a change in non-HDL-C levels will be determined.
Measured: 8 weeks
The difference in the proportion of participants from baseline to 12 weeks achieving a change in non-HDL-C levels
The difference in the proportion of participants from baseline to 12 weeks achieving a change in non-HDL-C levels will be determined.
Measured: 12 weeks
The difference in the proportion of participants from baseline to 16 weeks achieving a change in non-HDL-C levels
The difference in the proportion of participants from baseline to 16 weeks achieving a change in non-HDL-C levels will be determined.
Measured: 16 weeks
The difference in the proportion of participants from baseline to 4 weeks achieving a change in the Triglyceride/HDL-C ratio
The difference in the proportion of participants from baseline to 4 weeks achieving a change in the Triglyceride/HDL-C ratio will be determined.
Measured: 4 weeks
The difference in the proportion of participants from baseline to 8 weeks achieving a change in the Triglyceride/HDL-C ratio
The difference in the proportion of participants from baseline to 8 weeks achieving a change in the Triglyceride/HDL-C ratio will be determined.
Measured: 8 weeks
The difference in the proportion of participants from baseline to 12 weeks achieving a change in the Triglyceride/HDL-C ratio
The difference in the proportion of participants from baseline to 12 weeks achieving a change in the Triglyceride/HDL-C ratio will be determined.
Measured: 12 weeks
The difference in the proportion of participants from baseline to 16 weeks achieving a change in the Triglyceride/HDL-C ratio
The difference in the proportion of participants from baseline to 16 weeks achieving a change in the Triglyceride/HDL-C ratio will be determined.
Measured: 16 weeks
The difference in the proportion of participants from baseline to 4 weeks achieving a change in the Total Cholesterol/HDL-C ratio
The difference in the proportion of participants from baseline to 4 weeks achieving a change in the Total Cholesterol/HDL-C ratio will be determined.
Measured: 4 weeks
The difference in the proportion of participants from baseline to 8 weeks achieving a change in the Total Cholesterol/HDL-C ratio
The difference in the proportion of participants from baseline to 8 weeks achieving a change in the Total Cholesterol/HDL-C ratio will be determined.
Measured: 8 weeks
The difference in the proportion of participants from baseline to 12 weeks achieving a change in the Total Cholesterol/HDL-C ratio
The difference in the proportion of participants from baseline to 12 weeks achieving a change in the Total Cholesterol/HDL-C ratio will be determined.
Measured: 12 weeks
The difference in the proportion of participants from baseline to 16 weeks achieving a change in the Total Cholesterol/HDL-C ratio
The difference in the proportion of participants from baseline to 16 weeks achieving a change in the Total Cholesterol/HDL-C ratio will be determined.
Measured: 16 weeks
The difference in the proportion of participants from baseline to 4 weeks achieving a change in the LDL-C/HDL-C ratio
The difference in the proportion of participants from baseline to 4 weeks achieving a change in the LDL-C/HDL-C ratio will be determined.
Measured: 4 weeks
The difference in the proportion of participants from baseline to 8 weeks achieving a change in the LDL-C/HDL-C ratio
The difference in the proportion of participants from baseline to 8 weeks achieving a change in the LDL-C/HDL-C ratio will be determined.
Measured: 8 weeks
The difference in the proportion of participants from baseline to 12 weeks achieving a change in the LDL-C/HDL-C ratio
The difference in the proportion of participants from baseline to 12 weeks achieving a change in the LDL-C/HDL-C ratio will be determined.
Measured: 12 weeks
The difference in the proportion of participants from baseline to 16 weeks achieving a change in the LDL-C/HDL-C ratio
The difference in the proportion of participants from baseline to 16 weeks achieving a change in the LDL-C/HDL-C ratio will be determined.
Measured: 16 weeks
The difference in change in ApoB48 concentration between Almond-enriched Diet Dose 1 and Almond-Enriched Diet Dose 2 compared to the Nut-Free Diet from baseline to 8 weeks
The difference in change in ApoB48 concentration between Almond-enriched Diet Dose 1 and Almond-Enriched Diet Dose 2 compared to the Nut-Free Diet from baseline to 8 weeks will be determined.
Measured: 8 weeks
The difference in change in ApoB48 concentration between Almond-enriched Diet Dose 1 and Almond-Enriched Diet Dose 2 compared to the Nut-Free Diet from baseline to 16 weeks
The difference in change in ApoB48 concentration between Almond-enriched Diet Dose 1 and Almond-Enriched Diet Dose 2 compared to the Nut-Free Diet from baseline to 16 weeks will be determined.
Measured: 16 weeks
The difference in change in ApoB100 concentration between Almond-enriched Diet Dose 1 and Almond-Enriched Diet Dose 2 compared to the Nut-Free Diet from baseline to 16 weeks
The difference in change in ApoB100 concentration between Almond-enriched Diet Dose 1 and Almond-Enriched Diet Dose 2 compared to the Nut-Free Diet from baseline to 16 weeks will be determined.
Measured: 16 weeks
The difference in change in ApoB100 concentration between Almond-enriched Diet Dose 1 and Almond-Enriched Diet Dose 2 compared to the Nut-Free Diet from baseline to 8 weeks
The difference in change in ApoB100 concentration between Almond-enriched Diet Dose 1 and Almond-Enriched Diet Dose 2 compared to the Nut-Free Diet from baseline to 8 weeks will be determined.
Measured: 8 weeks
The difference in change in cardiovascular disease risk between Almond-enriched Diet Dose 1 and Almond-Enriched Diet Dose 2 compared to the Nut-Free Diet from baseline to 8 weeks
The difference in change in cardiovascular disease (CVD) risk between Almond-enriched Diet Dose 1 and Almond-Enriched Diet Dose 2 compared to the Nut-Free Diet from baseline to 8 weeks will be determined. Cardiovascular disease risk scores will be assessed by Framingham CVD Risk Scores, which is a gender-specific algorithm used to estimate the 10-year cardiovascular risk of an individual.
Measured: 8 weeks
The difference in change in cardiovascular disease risk between Almond-enriched Diet Dose 1 and Almond-Enriched Diet Dose 2 compared to the Nut-Free Diet from baseline to 16 weeks
The difference in change in cardiovascular disease (CVD) risk between Almond-enriched Diet Dose 1 and Almond-Enriched Diet Dose 2 compared to the Nut-Free Diet from baseline to 16 weeks will be determined. Cardiovascular disease risk scores will be assessed by Framingham CVD Risk Scores, which is a gender-specific algorithm used to estimate the 10-year cardiovascular risk of an individual.
Measured: 16 weeks
The change in weight from baseline to 4 weeks between Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2 and the Nut-Free Diet
The change in weight from baseline to 4 weeks between Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2 and the Nut-Free Diet will be determined.
Measured: 4 weeks
The change in weight from baseline to 8 weeks between Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2 and the Nut-Free Diet
The change in weight from baseline to 8 weeks between Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2 and the Nut-Free Diet will be determined.
Measured: 8 weeks
The change in weight from baseline to 12 weeks between Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2 and the Nut-Free Diet
The change in weight from baseline to 12 weeks between Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2 and the Nut-Free Diet will be determined.
Measured: 12 weeks
The change in weight from baseline to 16 weeks between Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2 and the Nut-Free Diet
The change in weight from baseline to 16 weeks between Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2 and the Nut-Free Diet will be determined.
Measured: 16 weeks
The change in Body Mass Index from baseline to 4 weeks between Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2 and the Nut-Free Diet
The change in Body Mass Index from baseline to 4 weeks between Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2 and the Nut-Free Diet will be determined.
Measured: 4 weeks
The change in Body Mass Index from baseline to 8 weeks between Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2 and the Nut-Free Diet
The change in Body Mass Index from baseline to 8 weeks between Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2 and the Nut-Free Diet will be determined.
Measured: 8 weeks
The change in Body Mass Index from baseline to 12 weeks between Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2 and the Nut-Free Diet
The change in Body Mass Index from baseline to 12 weeks between Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2 and the Nut-Free Diet will be determined.
Measured: 12 weeks
The change in Body Mass Index from baseline to 16 weeks between Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2 and the Nut-Free Diet
The change in Body Mass Index from baseline to 16 weeks between Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2 and the Nut-Free Diet will be determined.
Measured: 16 weeks
The change in Sagittal Abdominal Diameter from baseline to 4 weeks between Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2 and the Nut-Free Diet
The change in Sagittal Abdominal Diameter from baseline to 4 weeks between Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2 and the Nut-Free Diet will be determined. Also known as abdominal height, Sagittal Abdominal Diameter will be measured with the participant in a supine position with straight legs after normal expiration. At the level of the iliac crest, Sagittal Abdominal Diameter is the distance between the examination table to the horizontal level using abdominal calipers. At least two separate measurements are to be taken at each visit. If the two measurements differ by more than 0.5 cm, a third measurement is to be taken and the two closest values will be averaged for final measurement.
Measured: 4 weeks
The change in Sagittal Abdominal Diameter from baseline to 8 weeks between Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2 and the Nut-Free Diet
The change in Sagittal Abdominal Diameter from baseline to 8 weeks between Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2 and the Nut-Free Diet will be determined. Also known as abdominal height, Sagittal Abdominal Diameter will be measured with the participant in a supine position with straight legs after normal expiration. At the level of the iliac crest, Sagittal Abdominal Diameter is the distance between the examination table to the horizontal level using abdominal calipers. At least two separate measurements are to be taken at each visit. If the two measurements differ by more than 0.5 cm, a third measurement is to be taken and the two closest values will be averaged for final measurement.
Measured: 8 weeks
The change in Sagittal Abdominal Diameter from baseline to 16 weeks between Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2 and the Nut-Free Diet
The change in Sagittal Abdominal Diameter from baseline to 16 weeks between Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2 and the Nut-Free Diet will be determined. Also known as abdominal height, Sagittal Abdominal Diameter will be measured with the participant in a supine position with straight legs after normal expiration. At the level of the iliac crest, Sagittal Abdominal Diameter is the distance between the examination table to the horizontal level using abdominal calipers. At least two separate measurements are to be taken at each visit. If the two measurements differ by more than 0.5 cm, a third measurement is to be taken and the two closest values will be averaged for final measurement.
Measured: 16 weeks
The change in Sagittal Abdominal Diameter from baseline to 12 weeks between Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2 and the Nut-Free Diet
The change in Sagittal Abdominal Diameter from baseline to 12 weeks between Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2 and the Nut-Free Diet will be determined. Also known as abdominal height, Sagittal Abdominal Diameter will be measured with the participant in a supine position with straight legs after normal expiration. At the level of the iliac crest, Sagittal Abdominal Diameter is the distance between the examination table to the horizontal level using abdominal calipers. At least two separate measurements are to be taken at each visit. If the two measurements differ by more than 0.5 cm, a third measurement is to be taken and the two closest values will be averaged for final measurement.
Measured: 12 weeks
The change in Waist Circumference from baseline to 4 weeks between Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2 and the Nut-Free Diet
The change in Waist Circumference from baseline to 4 weeks between Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2 and the Nut-Free Diet will be determined. Measurements will be performed when standing at the part of the trunk located midway between the lower costal margin and the iliac crest. At least two separate measurements are to be taken at each visit. If the two measurements differ by more than 10%, a third measurement is to be taken and the two closest values will be averaged for final measurement. The height of the waist will be also recorded at baseline, and then used to determine the waist throughout the study in order to ensure a consistent measurement at all visits.
Measured: 4 weeks
The change in Waist Circumference from baseline to 8 weeks between Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2 and the Nut-Free Diet
The change in Waist Circumference from baseline to 8 weeks between Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2 and the Nut-Free Diet will be determined. Measurements will be performed when standing at the part of the trunk located midway between the lower costal margin and the iliac crest. At least two separate measurements are to be taken at each visit. If the two measurements differ by more than 10%, a third measurement is to be taken and the two closest values will be averaged for final measurement. The height of the waist will be also recorded at baseline, and then used to determine the waist throughout the study in order to ensure a consistent measurement at all visits.
Measured: 8 weeks
The change in Waist Circumference from baseline to 12 weeks between Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2 and the Nut-Free Diet
The change in Waist Circumference from baseline to 12 weeks between Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2 and the Nut-Free Diet will be determined. Measurements will be performed when standing at the part of the trunk located midway between the lower costal margin and the iliac crest. At least two separate measurements are to be taken at each visit. If the two measurements differ by more than 10%, a third measurement is to be taken and the two closest values will be averaged for final measurement. The height of the waist will be also recorded at baseline, and then used to determine the waist throughout the study in order to ensure a consistent measurement at all visits.
Measured: 12 weeks
The change in Waist Circumference from baseline to 16 weeks between Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2 and the Nut-Free Diet
The change in Waist Circumference from baseline to 16 weeks between Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2 and the Nut-Free Diet will be determined. Measurements will be performed when standing at the part of the trunk located midway between the lower costal margin and the iliac crest. At least two separate measurements are to be taken at each visit. If the two measurements differ by more than 10%, a third measurement is to be taken and the two closest values will be averaged for final measurement. The height of the waist will be also recorded at baseline, and then used to determine the waist throughout the study in order to ensure a consistent measurement at all visits.
Measured: 16 weeks
The change in Waist to Hip Ratio from baseline to 16 weeks between Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2 and the Nut-Free Diet
The change in Waist to Hip Ratio from baseline to 16 weeks between Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2 and the Nut-Free Diet will be determined.
Measured: 16 weeks
The change in Waist to Hip Ratio from baseline to 12 weeks between Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2 and the Nut-Free Diet
The change in Waist to Hip Ratio from baseline to 12 weeks between Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2 and the Nut-Free Diet will be determined.
Measured: 12 weeks
The change in Waist to Hip Ratio from baseline to 8 weeks between Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2 and the Nut-Free Diet
The change in Waist to Hip Ratio from baseline to 8 weeks between Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2 and the Nut-Free Diet will be determined.
Measured: 8 weeks
The change in Waist to Hip Ratio from baseline to 4 weeks between Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2 and the Nut-Free Diet
The change in Waist to Hip Ratio from baseline to 4 weeks between Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2 and the Nut-Free Diet will be determined.
Measured: 4 weeks
The change in blood pressure from baseline to 4 weeks between Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2 and the Nut-Free Diet
The change in blood pressure from baseline to 4 weeks between Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2 and the Nut-Free Diet will be determined.
Measured: 4 weeks
The change in blood pressure from baseline to 8 weeks between Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2 and the Nut-Free Diet
The change in blood pressure from baseline to 8 weeks between Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2 and the Nut-Free Diet will be determined.
Measured: 8 weeks
The change in blood pressure from baseline to 12 weeks between Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2 and the Nut-Free Diet
The change in blood pressure from baseline to 12 weeks between Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2 and the Nut-Free Diet will be determined.
Measured: 12 weeks
The change in blood pressure from baseline to 16 weeks between Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2 and the Nut-Free Diet
The change in blood pressure from baseline to 16 weeks between Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2 and the Nut-Free Diet will be determined.
Measured: 16 weeks
The difference in change in serum α-tocopherol concentrations from baseline to 16 weeks between Almond-enriched Diet Dose 1 and Almond-Enriched Diet Dose 2 compared to the Nut-Free Diet
The difference in change in serum α-tocopherol concentrations from baseline to 16 weeks between Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2 and the Nut-Free Diet will be determined.
Measured: 16 weeks
The difference in change in serum α-tocopherol concentrations from baseline to 12 weeks between Almond-enriched Diet Dose 1 and Almond-Enriched Diet Dose 2 compared to the Nut-Free Diet
The difference in change in serum α-tocopherol concentrations from baseline to 12 weeks between Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2 and the Nut-Free Diet will be determined.
Measured: 12 weeks
The difference in change in serum α-tocopherol concentrations from baseline to 8 weeks between Almond-enriched Diet Dose 1 and Almond-Enriched Diet Dose 2 compared to the Nut-Free Diet
The difference in change in serum α-tocopherol concentrations from baseline to 8 weeks between Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2 and the Nut-Free Diet will be determined.
Measured: 8 weeks
The difference in change in serum α-tocopherol concentrations from baseline to 4 weeks between Almond-enriched Diet Dose 1 and Almond-Enriched Diet Dose 2 compared to the Nut-Free Diet
The difference in change in serum α-tocopherol concentrations from baseline to 4 weeks between Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2 and the Nut-Free Diet will be determined.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2022
- Study start10 Jan 2022
- Primary completion18 Nov 2023
- Study completion18 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HDL-CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Almond Board of California
- Sponsor type
- University, hospital or other
- Collaborators
- KGK Science Inc.
- Responsible party
- Sponsor
- Investigators
- David Crowley, MD, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05174663
- Sponsor's protocol ID
- 21ABCFA01
- Status last verified
- Jan 2023
- First submitted
- 13 Dec 2021
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Comparator-controlled Parallel Study to Investigate the Dose Response of an Almond-enriched Diet on Optimizing HDL-C in a Population With Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT05174663
- Acronym / sponsor ID
- 21ABCFA01
- Conditions
- HDL-C, Hypercholesterolemia
- Keywords
- Hypercholesterolemia, HDL-C, Almond-enriched diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Almond Board of CaliforniaUniversity, hospital or other
- Collaborators
- KGK Science Inc.
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 18 Nov 2023 (actual)
- Study completion
- 18 Nov 2023 (actual)
- First posted
- 3 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine the quantity of almonds (1.5 oz or 2.5 oz) consumed as a snack that will provide optimal increases in HDL-C levels.
Detailed description
Elevated lipid levels are a major modifiable risk factor for cardiovascular disease (CVD), which is the leading cause of death worldwide, accounting for over 17.8 million deaths globally, equating to approximately 71 million Americans with the total annual cost associated with CVD approximating $351.3 billion USD. The National Cholesterol Education Program (NCEP) ATP III Guidelines and supporting literature recommend diet and lifestyle approaches for patients with elevated lipid levels prior to lipid lowering medication, as changing lifestyle and diet cost less than medications and does not lead to polypharmacy or unwanted side effects. Low nut and seed consumption has been identified as the leading dietary risk factor attributed to ischemic heart disease. Indeed, studies have demonstrated that almond consumption reduces total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and triglyceride (TG) levels compared to no almond controls or substitutions. Additionally, emerging and predictive CVD risk factors such as abdominal obesity and concentrations of Apolipoprotein (ApoB), for which a dose-response effect may also be present, are also improved by almond consumption.
While the benefits of an almond-rich diet on TC, TG, and LDL-C are clear, the effects of almonds on high-density lipoprotein cholesterol (HDL-C) levels is less clear. In populations with hyperlipidemia, almond consumption appears to improve HDL-C, among other lipid markers. Yet, a recent systematic-review and meta-analysis reported a significant decrease in HDL-C compared to control across 12 studies. It is possible that a dose-response relationship exists for almond consumption and HDL-C levels. Almond consumption of ≤42.5 g/day significantly decreased LDL-C/HDL-C, TC/HDL-C and ApoB compared to control, however, significant reductions in TC, BP and body weight were only observed with >42.5 g of almonds/day. Sabate et al., found that the NCEP Step I Diet as well as a low almond diet (10% from calories) significantly reduced HDL-C by 3% and 4%, respectively. However, a high almond-diet (20% from calories) maintained HDL-C levels, while having favorable changes on LDL-C, LDL-C/HDL-C and ApoB/ApoA . Daily almond consumption between 37-73 g/day (~1.3-2.5 oz/day) resulted in significantly higher HDL-C levels compared to a muffin control, with the higher dose of almonds (73 g/day) resulting in a greater increase in HDL-C compared to a lower dose (37 g/day). Additionally, the majority of studies are of limited length and often less than 12 weeks long. A previous study on the long term effects of almonds and other lipid-modulating foods found the greatest reductions on LDL-C and TC/HDL-C were not observed until 12 weeks, and then maintained. Further, it has been suggested that other outcomes such as BP, body weight and abdominal obesity may require longer term consumption of almonds to show beneficial changes. Therefore, it is likely heterogeneity in the effect of HDL-C levels with almond consumption is due to inadequate study duration, background diet, population, control used or too low quantity of almonds.
The existing FDA health claim for almonds states: "scientific evidence suggests, but does not prove, that eating 1.5 ounces per day of most nuts, such as almonds, as part of a diet low in saturated fat and cholesterol may reduce the risk of heart disease". Despite the benefits of almonds on cardiometabolic health, clinical trials designed to determine the optimal dose of almonds on the improvement of lipid profile in a population at greater risk of CVD have not been conducted. This study will address this research gap and establish the optimal dose of almonds for improving HDL-C and other CVD markers and ultimately lowering risk in a population at increased risk of disease development. The specific aim of this study is to demonstrate the efficacy of consuming increasing quantities of almonds on blood lipid levels in adults with hypercholesterolemia. Two doses of almonds will be used, 1.5 oz and 2.5 oz, referred to the Almond-enriched Diet Dose 1 (AD1) and Almond-enriched Diet Dose 2 (AD2), respectively, compared to a Nut-Free Diet (NFD). This study will determine the optimal quantity of almonds consumed as a snack that will provide the most clinically relevant increase of HDL-C levels. Further, this study will investigate the dose-response of almonds on other lipid profile markers, blood pressure (BP), weight, and markers of abdominal obesity in a population with hypercholesterolemia. The hypothesis is that there will be an improvement in HDL-C in a dose-dependent manner with increased consumption of almonds for 16 weeks.
Participants in this study represent a target population that aligns with the goals of healthcare to provide lifestyle management prior to the introduction of prescription medication plans. The study is to be conducted in a population at risk of developing heart disease, who have hypercholesterolemia based on the NCEP definition (LDL-C levels >4.1 mmol/L (>160 mg/dL)). Currently, approximately 53% of the North American population is considered to have elevated LDL-C levels, yet less than half receive treatment. Participants aged 30 to 65 years will be considered for enrolment to avoid complications related to advanced age and a body mass index (BMI) of and up to 34.9 kg/m2 will eliminate confounders related to advanced obesity. Significant metabolic or physiological conditions that may affect lipid levels will be excluded and any participants on prescribed lipid lowering medication will be excluded to limit confounders. Current use of supplements known to affect blood lipid levels, vitamin E status or tree nuts that may impact study outcomes will be excluded unless participants undergo an appropriate washout period prior to enrollment. As well, an extensive list of exclusions in place will ensure that eligibility is based on establishing health and each participants' eligibility will be overseen by the Qualified Investigator (QI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Almond-enriched diet dose 1 | Experimental | Other: Almond-enriched diet - 1.5 ozParticipants will be instructed to ingest 1.5 oz of almonds daily for 16 weeks. The 1.5 oz of almonds can be split into a morning and afternoon snack. Participants will be advised not to exceed 2 doses of almonds daily. If a dose is missed, participants should take the missed dose as soon as the participants remember. |
| Almond-enriched diet dose 2 | Experimental | Other: Almond-enriched diet - 2.5 ozParticipants will be instructed to ingest 2.5 oz of almonds daily for 16 weeks. The 2.5 oz of almonds can be split into a morning and afternoon snack. Participants will be advised not to exceed 2 doses of almonds daily. If a dose is missed, participants should take the missed dose as soon as the participants remember. |
| Nut-free diet | Other | Other: Control snackParticipants will be instructed to ingest the control snack (Iso-caloric [to 1.5 oz of almonds] control snack of chocolate chip cookies or Oreo cookies) daily for 16 weeks. The control snack can be split into a morning and afternoon snack. Participants will be advised not to exceed 2 doses of snack daily. If a dose is missed, participants should take the missed dose as soon as the participants remember. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Males and Females between 30-65 years of age, inclusive
- BMI between 25.0 - 34.9 kg/m2, inclusive
- Individual is not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening
- Or,
- Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
Key exclusion criteria (21 listed)
- Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
- Allergy, sensitivity, or intolerance to the investigational product/control snack ingredients
- Current regular consumption of nuts >2 times per week, unless willing to washout prior to baseline
- Current use of prescribed lipid lowering medications as assessed by QI (see Section 7.3.1)
- Current use of over-the-counter medications or supplements known to affect blood lipid levels (i.e. omega-3) or vitamin E status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Almond-enriched diet - 1.5 ozParticipants will receive 1.5 oz of almonds consumed as a snack daily for 16 weeks. | Other | Almond-enriched diet dose 1 |
| Almond-enriched diet - 2.5 ozParticipants will receive 2.5 oz of almonds consumed as a snack daily for 16 weeks. | Other | Almond-enriched diet dose 2 |
| Control snackParticipants will receive a control snack daily for 16 weeks. | Other | Nut-free diet |
Primary outcome
Change from baseline to week 16 in HDL-C levels between the Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2, and Nut-Free Diet
Time frame: 16 weeks
The change from baseline in HDL-C levels at week 16 between Almond-enriched Diet Dose 1 (AD1), Almond-Enriched Diet Dose 2 (AD2), and Nut-Free Diet (NFD) will be determined.
77 secondary outcomes
Change from baseline to week 4 in HDL-C levels between the Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2, and Nut-Free Diet
Time frame: 4 weeks
Change from baseline to week 8 in HDL-C levels between the Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2, and Nut-Free Diet
Time frame: 8 weeks
Change from baseline to week 12 in HDL-C levels between the Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2, and Nut-Free Diet
Time frame: 12 weeks
The difference in the proportion of participants from baseline to 4 weeks achieving a clinically relevant increase in HDL-C levels
Time frame: 4 weeks
The difference in the proportion of participants from baseline to 8 weeks achieving a clinically relevant increase in HDL-C levels
Time frame: 8 weeks
The difference in the proportion of participants from baseline to 12 weeks achieving a clinically relevant increase in HDL-C levels
Time frame: 12 weeks
The difference in the proportion of participants from baseline to 16 weeks achieving a clinically relevant increase in HDL-C levels
Time frame: 16 weeks
The difference in the proportion of participants from baseline to 16 weeks achieving no change or an increase in HDL-C levels
Time frame: 16 weeks
The difference in the proportion of participants from baseline to 4 weeks achieving no change or an increase in HDL-C levels
Time frame: 4 weeks
The difference in the proportion of participants from baseline to 8 weeks achieving no change or an increase in HDL-C levels
Time frame: 8 weeks
The difference in the proportion of participants from baseline to 12 weeks achieving no change or an increase in HDL-C levels
Time frame: 12 weeks
The difference in the proportion of participants from baseline to 4 weeks achieving movement from HDL-C categories
Time frame: 4 weeks
The difference in the proportion of participants from baseline to 8 weeks achieving movement from HDL-C categories
Time frame: 8 weeks
The difference in the proportion of participants from baseline to 12 weeks achieving movement from HDL-C categories
Time frame: 12 weeks
The difference in the proportion of participants from baseline to 16 weeks achieving movement from HDL-C categories
Time frame: 16 weeks
The difference in the proportion of participants from baseline to 16 weeks achieving a change in total cholesterol levels
Time frame: 16 weeks
The difference in the proportion of participants from baseline to 4 weeks achieving a change in total cholesterol levels
Time frame: 4 weeks
The difference in the proportion of participants from baseline to 8 weeks achieving a change in total cholesterol levels
Time frame: 8 weeks
The difference in the proportion of participants from baseline to 12 weeks achieving a change in total cholesterol levels
Time frame: 12 weeks
The difference in the proportion of participants from baseline to 4 weeks achieving a change in LDL-C levels
Time frame: 4 weeks
The difference in the proportion of participants from baseline to 12 weeks achieving a change in LDL-C levels
Time frame: 12 weeks
The difference in the proportion of participants from baseline to 16 weeks achieving a change in LDL-C levels
Time frame: 16 weeks
The difference in the proportion of participants from baseline to 8 weeks achieving a change in LDL-C levels
Time frame: 8 weeks
The difference in the proportion of participants from baseline to 4 weeks achieving a change in triglyceride levels
Time frame: 4 weeks
The difference in the proportion of participants from baseline to 8 weeks achieving a change in triglyceride levels
Time frame: 8 weeks
The difference in the proportion of participants from baseline to 12 weeks achieving a change in triglyceride levels
Time frame: 12 weeks
The difference in the proportion of participants from baseline to 16 weeks achieving a change in triglyceride levels
Time frame: 16 weeks
The difference in the proportion of participants from baseline to 4 weeks achieving a change in non-HDL-C levels
Time frame: 4 weeks
The difference in the proportion of participants from baseline to 8 weeks achieving a change in non-HDL-C levels
Time frame: 8 weeks
The difference in the proportion of participants from baseline to 12 weeks achieving a change in non-HDL-C levels
Time frame: 12 weeks
The difference in the proportion of participants from baseline to 16 weeks achieving a change in non-HDL-C levels
Time frame: 16 weeks
The difference in the proportion of participants from baseline to 4 weeks achieving a change in the Triglyceride/HDL-C ratio
Time frame: 4 weeks
The difference in the proportion of participants from baseline to 8 weeks achieving a change in the Triglyceride/HDL-C ratio
Time frame: 8 weeks
The difference in the proportion of participants from baseline to 12 weeks achieving a change in the Triglyceride/HDL-C ratio
Time frame: 12 weeks
The difference in the proportion of participants from baseline to 16 weeks achieving a change in the Triglyceride/HDL-C ratio
Time frame: 16 weeks
The difference in the proportion of participants from baseline to 4 weeks achieving a change in the Total Cholesterol/HDL-C ratio
Time frame: 4 weeks
The difference in the proportion of participants from baseline to 8 weeks achieving a change in the Total Cholesterol/HDL-C ratio
Time frame: 8 weeks
The difference in the proportion of participants from baseline to 12 weeks achieving a change in the Total Cholesterol/HDL-C ratio
Time frame: 12 weeks
The difference in the proportion of participants from baseline to 16 weeks achieving a change in the Total Cholesterol/HDL-C ratio
Time frame: 16 weeks
The difference in the proportion of participants from baseline to 4 weeks achieving a change in the LDL-C/HDL-C ratio
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Crowley, MD principal investigator
KGK Science Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Almond-enriched diet - 1.5 oz and Almond-enriched diet - 2.5 oz in people with HDL-C and Hypercholesterolemia, run by Almond Board of California at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to week 16 in HDL-C levels between the Almond-enriched Diet Dose 1, Almond-Enriched Diet Dose 2, and Nut-Free Diet (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.