DyslipidemiaNCT01792648
Effects of Almond Intake on Atherogenic Lipoprotein Particles
A study testing Standard reference diet, Almond supplemented diet and Low carbohydrate reference diet in people with Dyslipidemia and Obesity, Abdominal, run by UCSF Benioff Children's Hospital Oakland at 1 site in United States.
Trial summary
Increased abdominal adiposity is a key feature of metabolic syndrome, which describes a cluster of cardiovascular disease (CVD) risk factors that also includes insulin resistance, high blood pressure and an atherogenic lipoprotein phenotype characterized by increased plasma triglycerides, low HDL-C, and increased… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemia, Obesity, Abdominal
- What is being tested?
- Standard reference diet, Almond supplemented diet and Low carbohydrate reference diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Apr 2016
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 20 or older
- Increased abdominal adiposity as defined by waist circumference ≥102 for men or ≥88 for women.
- Fasting blood sugar (FBS) < 126 mg/dl
- Weight stable for > 3 months.
Who cannot join
- History of coronary heart disease, cerebrovascular disease, peripheral vascular disease, bleeding disorder, liver or renal disease, diabetes, lung disease, HIV, or cancer (other than skin cancer) in the last 5 years.
- Taking hormones or drugs known to affect lipid metabolism or blood pressure.
- Systolic blood pressure > 160 mm Hg and diastolic blood pressure > 95 mm Hg.
- Body mass index (BMI) > 38 kg/m2
- User of nicotine products or recreational drugs
- Refusal to abstain from alcohol or dietary supplements during the study.
Show all 10Show fewer
- Total- and LDL-C > 95th percentile for sex and age.
- Fasting triglycerides > 50mg/dl and > 500 mg/dl
- Abnormal thyroid stimulating hormone (TSH) levels.
- Pregnant or breast-feeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Cholesterol Research Center
Berkeley, California, 94705
About this study
Official title: Effects of Almond Intake on Atherogenic Lipoprotein Particles in Individuals With Increased Abdominal Adiposity
Increased abdominal adiposity is a key feature of metabolic syndrome, which describes a cluster of cardiovascular disease (CVD) risk factors that also includes insulin resistance, high blood pressure and an atherogenic lipoprotein phenotype characterized by increased plasma triglycerides, low HDL-C, and increased levels of small LDL particles. While lifestyle intervention remains the cornerstone for managing obesity and metabolic syndrome, the optimal dietary macronutrient distribution for improving blood lipids and CVD risk remains a topic of controversy. While both low carbohydrate diets and weight reduction are effective for managing atherogenic dyslipidemia, long-term compliance is low, and it becomes imperative to identify alternative dietary approaches.
Increased consumption of almonds has been shown to lower LDL-C, an effect that exceeds that predicted from changes in fatty acid intake. However, although LDL-C lowering by almonds has been demonstrated in patients with diabetes, there have been no trials in non-diabetic patients with abdominal obesity. Moreover, there is limited information of the effects of almond intake on LDL particle subclasses.
Read more
The overall objective of the present study is to determine whether lipoprotein measures of CVD risk in individuals with increased abdominal adiposity are reduced by almond supplementation in a diet with overall macronutrient content that conforms to current guidelines. Our main hypothesis is that in these individuals, almond consumption can reduce levels of small and medium LDL particles without the need to restrict dietary carbohydrates to levels below those currently recommended.
This hypothesis will be tested by comparing the lipoprotein effects of an almond-supplemented diet (20%E) with those of two reference diets that do not contain almond products: one with similar content of carbohydrate, protein, and fat (standard reference), and the other in which carbohydrate content is reduced by substitution of protein and monounsaturated fat (low-carbohydrate reference).
We will provide the diets for 3 weeks each in a randomized 3-period crossover design to 40 individuals with increased abdominal adiposity. We will test whether the almond supplemented diet will result in lower levels of lipoprotein measures of CVD risk, specifically LDL-C and small and medium LDL particles, compared to either the standard or low-carbohydrate reference diets.
- Conditions
- Dyslipidemia, Obesity, Abdominal
- Being tested
- Standard reference diet, Almond supplemented diet, Low carbohydrate reference diet
- Keywords
- Almond, Carbohydrate, Diet, Cholesterol
- Medical subject headings
- Dyslipidemias, Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard reference dietOther
50% energy as carbohydrate, 15% energy as protein, 35% energy as total fat
Almond supplemented dietOther
50% energy as carbohydrate, 15% energy as protein, 35% energy as total fat, 20% energy from almonds
Low carbohydrate reference dietOther
26% energy from carbohydrate, 29% energy from protein, 45% energy from total fat
| Study group | Role | What they receive |
|---|---|---|
| Standard Reference Diet | Active comparator | Not described Receives: Other: Standard reference diet |
| Almond Supplemented Diet | Experimental | Not described Receives: Other: Almond supplemented diet |
| Low Carbohydrate Reference Diet | Active comparator | Not described Receives: Other: Low carbohydrate reference diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total and LDL cholesterol
Change in total and LDL cholesterol between each of the 3 test diets
Measured: 3 weeks, 8 weeks, 13 weeks
Change in small and medium LDL particles
Change in small and medium LDL particles between each of the 3 test diets
Measured: 3 weeks, 8 weeks, and 13 weeks
Change in apolipoprotein B
Change in apolipoprotein B between each of the 3 test diets
Measured: 3 weeks, 8 week, 13 weeks
Secondary outcomes (7)
Change in total/HDL-cholesterol ratio
Change in total/HDL-cholesterol ratio between each of the 3 test diets
Measured: 3 weeks, 8 weeks, 13 weeks
Change in LDL peak particle diameter
Change in LDL peak particle diameter between each of the 3 test diets
Measured: 3 weeks, 8 week, 13 weeks
Change in plasma triglycerides
Change in plasma triglycerides between each of the 3 test diets
Measured: 3 weeks, 8 weeks, 13 weeks
Change in HDL-cholesterol
Change in HDL-cholesterol between each of the 3 test diets
Measured: 3 weeks, 8 weeks, 13 weeks
Change in large HDL particles
Change in large HDL particles between each of the 3 test diets
Measured: 3 weeks, 8 weeks, 13 weeks
Change in apolipoprotein AI
Change in apolipoprotein AI between each of the 3 test diets
Measured: 3 weeks, 8 weeks, 13 weeks
Change in HOMA-IR
Change in homeostatic model assessment insulin resistance (HOMA-IR) after each of the 3 test diets
Measured: 3 weeks, 8 weeks, 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startApr 2013
- Primary completionFeb 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiaStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCSF Benioff Children's Hospital Oakland
- Sponsor type
- University, hospital or other
- Collaborators
- Almond Board of California
- Responsible party
- Sponsor
- Investigators
- Ronald M Krauss, MD, Principal investigator, UCSF Benioff Children's Hospital Oakland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01792648
- Sponsor's protocol ID
- MM2222
- Status last verified
- Oct 2017
- First submitted
- 26 Apr 2012
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Williams PT, Bergeron N, Chiu S, Krauss RM. A randomized, controlled trial on the effects of almonds on lipoprotein response to a higher carbohydrate, lower fat diet in men and women with abdominal adiposity. Lipids Health Dis. 2019 Apr 3;18(1):83. doi: 10.1186/s12944-019-1025-4.
PubMed 30943980
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Almond Intake on Atherogenic Lipoprotein Particles in Individuals With Increased Abdominal Adiposity
- ClinicalTrials.gov ID
- NCT01792648
- Acronym / sponsor ID
- MM2222
- Conditions
- Dyslipidemia, Obesity, Abdominal
- Keywords
- Almond, Carbohydrate, Diet, Cholesterol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- UCSF Benioff Children's Hospital OaklandUniversity, hospital or other
- Collaborators
- Almond Board of California
- Study start
- Apr 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 15 Feb 2013 (estimated)
- 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.
Increased abdominal adiposity is a key feature of metabolic syndrome, which describes a cluster of cardiovascular disease (CVD) risk factors that also includes insulin resistance, high blood pressure and an atherogenic lipoprotein phenotype characterized by increased plasma triglycerides, low HDL-C, and increased levels of small LDL particles. While lifestyle intervention remains the cornerstone for managing obesity and metabolic syndrome, the optimal dietary macronutrient distribution for improving blood lipids and CVD risk remains a topic of controversy. While both low carbohydrate diets and weight reduction are effective for managing atherogenic dyslipidemia, long-term compliance is low, and it becomes imperative to identify alternative dietary approaches.
Increased consumption of almonds has been shown to lower LDL-C, an effect that exceeds that predicted from changes in fatty acid intake. However, although LDL-C lowering by almonds has been demonstrated in patients with diabetes, there have been no trials in non-diabetic patients with abdominal obesity. Moreover, there is limited information of the effects of almond intake on LDL particle subclasses.
The overall objective of the present study is to determine whether lipoprotein measures of CVD risk in individuals with increased abdominal adiposity are reduced by almond supplementation in a diet with overall macronutrient content that conforms to current guidelines. Our main hypothesis is that in these individuals, almond consumption can reduce levels of small and medium LDL particles without the need to restrict dietary carbohydrates to levels below those currently recommended.
This hypothesis will be tested by comparing the lipoprotein effects of an almond-supplemented diet (20%E) with those of two reference diets that do not contain almond products: one with similar content of carbohydrate, protein, and fat (standard reference), and the other in which carbohydrate content is reduced by substitution of protein and monounsaturated fat (low-carbohydrate reference).
We will provide the diets for 3 weeks each in a randomized 3-period crossover design to 40 individuals with increased abdominal adiposity. We will test whether the almond supplemented diet will result in lower levels of lipoprotein measures of CVD risk, specifically LDL-C and small and medium LDL particles, compared to either the standard or low-carbohydrate reference diets.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Reference Diet | Active comparator | Other: Standard reference diet |
| Almond Supplemented Diet | Experimental | Other: Almond supplemented diet |
| Low Carbohydrate Reference Diet | Active comparator | Other: Low carbohydrate reference diet |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 20 or older
- Increased abdominal adiposity as defined by waist circumference ≥102 for men or ≥88 for women.
- Fasting blood sugar (FBS) < 126 mg/dl
- Weight stable for > 3 months.
Key exclusion criteria (10 listed)
- History of coronary heart disease, cerebrovascular disease, peripheral vascular disease, bleeding disorder, liver or renal disease, diabetes, lung disease, HIV, or cancer (other than skin cancer) in the last 5 years.
- Taking hormones or drugs known to affect lipid metabolism or blood pressure.
- Systolic blood pressure > 160 mm Hg and diastolic blood pressure > 95 mm Hg.
- Body mass index (BMI) > 38 kg/m2
- User of nicotine products or recreational drugs
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 |
|---|---|---|
| Standard reference diet50% energy as carbohydrate, 15% energy as protein, 35% energy as total fat | Other | Standard Reference Diet |
| Almond supplemented diet50% energy as carbohydrate, 15% energy as protein, 35% energy as total fat, 20% energy from almonds | Other | Almond Supplemented Diet |
| Low carbohydrate reference diet26% energy from carbohydrate, 29% energy from protein, 45% energy from total fat | Other | Low Carbohydrate Reference Diet |
Primary outcome
Change in Total and LDL cholesterol
Time frame: 3 weeks, 8 weeks, 13 weeks
Change in total and LDL cholesterol between each of the 3 test diets
Change in small and medium LDL particles
Time frame: 3 weeks, 8 weeks, and 13 weeks
Change in small and medium LDL particles between each of the 3 test diets
Change in apolipoprotein B
Time frame: 3 weeks, 8 week, 13 weeks
Change in apolipoprotein B between each of the 3 test diets
7 secondary outcomes
Change in total/HDL-cholesterol ratio
Time frame: 3 weeks, 8 weeks, 13 weeks
Change in LDL peak particle diameter
Time frame: 3 weeks, 8 week, 13 weeks
Change in plasma triglycerides
Time frame: 3 weeks, 8 weeks, 13 weeks
Change in HDL-cholesterol
Time frame: 3 weeks, 8 weeks, 13 weeks
Change in large HDL particles
Time frame: 3 weeks, 8 weeks, 13 weeks
Change in apolipoprotein AI
Time frame: 3 weeks, 8 weeks, 13 weeks
Change in HOMA-IR
Time frame: 3 weeks, 8 weeks, 13 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 6 Nov 2017.
- Derived from this study: PubMed 30943980Williams PT, Bergeron N, Chiu S, Krauss RM. A randomized, controlled trial on the effects of almonds on lipoprotein response to a higher carbohydrate, lower fat diet in men and women with abdominal adiposity. Lipids Health Dis. 2019 Apr 3;18(1):83. doi: 10.1186/s12944-019-1025-4.
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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.
Ronald M Krauss, MD principal investigator
UCSF Benioff Children's Hospital Oakland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard reference diet, Almond supplemented diet and Low carbohydrate reference diet in people with Dyslipidemia and Obesity, Abdominal, run by UCSF Benioff Children's Hospital Oakland at 1 site in United States.
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 4 inclusion and 10 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 6 Nov 2017. 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 United States. 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 in Total and LDL cholesterol (time frame: 3 weeks, 8 weeks, 13 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01792648, which also lists 1 linked publication.
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 6 Nov 2017.