HypercholesterolemiaNCT04376632
Diets Enriched With Pecans
A study testing Pecan ADD and Pecan SUB in people with Hypercholesterolemia and Obesity, run by University of Georgia at 1 site in United States.
Trial summary
Background: Previous studies report that daily pecan consumption reduces cholesterol in healthy adults while promoting weight maintenance. Purpose: To examine the impact of daily pecan consumption with and without dietary substitution instructions for an 8-week period on markers of health in adults at risk for… Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia, Obesity
- What is being tested?
- Pecan ADD and Pecan SUB
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2018to 1 Jun 2021
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages 30-75y with higher cholesterol levels or BMI of 28 kg/m2 or greater (A higher cholesterol level is indicated by "Borderline High/Undesirable" in two or more of the variables (total cholesterol 200-239 mg/dL, LDL cholesterol 130-159 mg/dL, triglycerides 150-199 mg/dL) or "High" in either total cholesterol (240 mg/dL and higher) or LDL (160 mg/dL or higher).
Who cannot join
- Familial hypercholesterolemia (individuals with LDL levels greater than the 95th percentile or HDL levels lower than the 20th percentile based on age and sex)
- Nut consumption >2 servings/week or tree nut butter consumption >3 servings/week
- Hormone replacement therapy <5 years
- Women who are pregnant or planning to become pregnant
- Regular exercise of >3 hours/week
- Weight gain or loss of >5% of body weight during last 3 months
Show all 22Show fewer
- Plans to begin a weight loss/exercise regiment
- History of medical or surgical events that could affect digestion or swallowing
- Gastrointestinal surgeries, conditions or disorders
- Chronic or metabolic diseases
- Atherosclerosis, previous myocardial infarction, stroke, cancer
- Fasting blood glucose levels >126 mg/dl
- Blood pressure >180/120 mmHg
- Medication use that affects digestion, absorption, metabolism
- Lipid-lowering medications
- Medications for diabetes or attention deficit disorders (with or without hyperactivity)
- Steroid/hormone therapies
- Individuals on medically prescribed or special diet
- Individuals with food allergies to foods specifically in the study
- Individuals taking fish oil supplements
- Excessive alcohol consumption (greater than 3 drinks/d for men; greater than 2 drinks/d for women)
- Tobacco or nicotine use
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Georgia- Department of Foods and Nutrition
Athens, Georgia, 30605
About this study
Official title: Comparison of Health Effects of Diets With and Without Pecans
Background: Previous studies report that daily pecan consumption reduces cholesterol in healthy adults while promoting weight maintenance.
Purpose: To examine the impact of daily pecan consumption with and without dietary substitution instructions for an 8-week period on markers of health in adults at risk for cardiovascular disease.
Read the detailed description
This was a single-blind, randomized controlled trial. The investigators recruited subjects with hypercholesterolemia (high blood cholesterol levels) or at higher risk for cardiovascular disease (CVD) (BMI > 28 kg/m2). Subjects were randomized into one of three groups: (1) the no nut group (CON), (2) pecan ADD (no diet instructions), and (3) pecan SUB (instructions to substitute pecans with isocaloric foods in habitual diet).
There was a screening visit and 3 testing visits: Baseline (visit 1), mid-visit at week 4 (visit 2), and post-visit at week 8 (visit 3). Anthropometrics, questionnaires, and a fasting blood sample were collected at each visit. A subset of participants participated in a saturated fatty acid meal challenge in which additional blood and metabolism measurements were collected.
Hypothesis: The investigators hypothesized that daily pecan consumption would result in significantly greater improvements in blood lipids, metabolism, and appetite compared to the control group. The investigators also hypothesized that pecan ADD group will result in a larger increase in body weight compared to the pecan SUB and control groups.
- Conditions
- Hypercholesterolemia, Obesity
- Being tested
- Pecan ADD, Pecan SUB
- Medical subject headings
- Hypercholesterolemia, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pecan ADDDietary supplement
Also called Pecan
Raw pecan halves without dietary substitution instructions
Pecan SUBDietary supplement
Also called Pecan
Raw pecan halves with instructions to substitute pecans with isocaloric foods in the habitual diet
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants in this group avoid all nuts for 8 weeks. |
| Pecan ADD | Experimental | Participants in this group consume 68 g of pecans/d with no additional dietary instructions and avoid all other nuts. Receives: Dietary Supplement: Pecan ADD |
| Pecan SUB | Experimental | Participants in this group consume 68 g of pecans/d with instructions to substitute pecans with isocaloric foods in the habitual diet. They are also instructed to avoid all other nuts. Receives: Dietary Supplement: Pecan SUB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in baseline fasting blood lipids at 4 weeks and 8 weeks
Total cholesterol (mg/dL), high-density lipoprotein (HDL) cholesterol (mg/dL), triglycerides (mg/dL), low-density lipoprotein (LDL) cholesterol (mg/dL), non-HDL cholesterol (mg/dL), apolipoprotein B (mg/dL)
Measured: Baseline, 4 weeks, 8 weeks
Change in baseline lipoprotein(a), lipoprotein particle number, and lipoprotein size at 4 and 8 weeks
Low-density lipoprotein (LDL) particle number (nmol/L), LDL small (nmol/L), LDL medium (nmol/L), HDL large (nmol/L), lipoprotein(a) (nmol/L)
Measured: Baseline, 4 weeks, 8 weeks
Change in baseline low-density lipoprotein (LDL) peak size at 4 and 8 weeks
LDL peak size (angstrom)
Measured: Baseline, 4 weeks, 8 weeks
Change in baseline weight at 4 and 8 weeks
Weight (kg)
Measured: Baseline, 4 weeks, 8 weeks
Change in baseline waist and hip circumference at 4 and 8 weeks
waist and hip circumference (cm)
Measured: Baseline, 4 weeks, 8 weeks
Change in baseline total body fat percentage at 4 and 8 weeks
Total body fat percentage (%)
Measured: Baseline, 4 weeks, 8 weeks
Secondary outcomes (11)
Change in fasting and postprandial peptide YY, cholecystokinin (CCK), and ghrelin from baseline to 8 weeks
Peptide YY (pg/mL), CCK (pg/mL) and ghrelin (pg/mL)
Measured: Data will be collected at fasting at baseline, 4 weeks and 8 weeks. Postprandial data will be collected at baseline and 8 weeks.
Change in fasting and postprandial glucose and triglycerides from baseline to 8 weeks
Glucose (mg/dL) and triglycerides (mg/dL)
Measured: Data will be collected at fasting at baseline, 4 weeks and 8 weeks. Postprandial data will be collected at baseline and 8 weeks.
Change in fasting and postprandial non-esterified free fatty acids (NEFA) from baseline to 8 weeks
NEFA (mEq/L)
Measured: Data will be collected at fasting at baseline, 4 weeks and 8 weeks. Postprandial data will be collected at baseline and 8 weeks.
Change in fasting and postprandial insulin from baseline to 8 weeks
Insulin (uU/mL)
Measured: Data will be collected at fasting at baseline, 4 weeks and 8 weeks. Postprandial data will be collected at baseline and 8 weeks.
Change in resting metabolic rate (RMR) from baseline to 8 weeks
RMR (kcals/d) measured via indirect calorimetry
Measured: Baseline and 8 weeks
Change in diet induced thermogenesis (DIT) from baseline to 8 weeks
DIT (kcals) measured via indirect calorimetry
Measured: Baseline and 8 weeks
Change in fasting and postprandial carbohydrate and fat oxidation from baseline to 8 weeks
Carbohydrate oxidation (g) and fat oxidation (g) measured via indirect calorimetry
Measured: Measured at fasting and for 3.5h postprandially at baseline and 8 weeks
Change in diet respiratory exchange ratio (RER) from baseline to 8 weeks
RER measured via indirect calorimetry
Measured: Measured at fasting and for 3.5h postprandially at baseline and 8 weeks
Change in fasting and postprandial lipid peroxidation from baseline to 8 weeks
Malondialdehyde (MDA) (uM) measured via Thiobarbituric acid reactive substances (TBARS) assay.
Measured: Measured at fasting and for 4 hours postprandially at baseline and 8 weeks
Change in fasting and postprandial total antioxidant capacity from baseline to 8 weeks
Total antioxidant capacity (uM trolox equivalents) measured via Oxygen Radical Absorbance Capacity (ORAC) assay.
Measured: Measured at fasting and for 4 hours postprandially at baseline and 8 weeks
Changes in fasting and postprandial hunger and satiety from baseline to 8 weeks
Hunger, fullness, prospective consumption, and desire to eat measured via a Visual Analog Scale (VAS) (mm). The range of scores on the continuous VAS is 0-100 mm. Zero represents no hunger, fullness, prospective consumption, and desire to eat, while 100 represents the greatest feeling of these outcomes.
Measured: Measured at fasting and for 4 hours postprandially at baseline and 8 weeks. Also, measured once per hour after the baseline and 8-week visits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start10 Aug 2018
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
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 HypercholesterolemiaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Georgia
- Sponsor type
- University, hospital or other
- Collaborators
- Georgia Pecan Commission
- Responsible party
- Principal investigator, Jamie Cooper, PhD, University of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04376632
- Sponsor's protocol ID
- STUDY00005985
- Status last verified
- May 2022
- First submitted
- 30 Apr 2020
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The plan is to share group averages through publication.
Publications
Guarneiri LL, Paton CM, Cooper JA. Pecan-Enriched Diets Alter Cholesterol Profiles and Triglycerides in Adults at Risk for Cardiovascular Disease in a Randomized, Controlled Trial. J Nutr. 2021 Oct 1;151(10):3091-3101. doi: 10.1093/jn/nxab248.
PubMed 34383903
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Health Effects of Diets With and Without Pecans
- ClinicalTrials.gov ID
- NCT04376632
- Acronym / sponsor ID
- STUDY00005985
- Conditions
- Hypercholesterolemia, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- University of GeorgiaUniversity, hospital or other
- Collaborators
- Georgia Pecan Commission
- Study start
- 10 Aug 2018 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 6 May 2020 (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.
Background: Previous studies report that daily pecan consumption reduces cholesterol in healthy adults while promoting weight maintenance.
Purpose: To examine the impact of daily pecan consumption with and without dietary substitution instructions for an 8-week period on markers of health in adults at risk for cardiovascular disease.
Detailed description
This was a single-blind, randomized controlled trial. The investigators recruited subjects with hypercholesterolemia (high blood cholesterol levels) or at higher risk for cardiovascular disease (CVD) (BMI > 28 kg/m2). Subjects were randomized into one of three groups: (1) the no nut group (CON), (2) pecan ADD (no diet instructions), and (3) pecan SUB (instructions to substitute pecans with isocaloric foods in habitual diet).
There was a screening visit and 3 testing visits: Baseline (visit 1), mid-visit at week 4 (visit 2), and post-visit at week 8 (visit 3). Anthropometrics, questionnaires, and a fasting blood sample were collected at each visit. A subset of participants participated in a saturated fatty acid meal challenge in which additional blood and metabolism measurements were collected.
Hypothesis: The investigators hypothesized that daily pecan consumption would result in significantly greater improvements in blood lipids, metabolism, and appetite compared to the control group. The investigators also hypothesized that pecan ADD group will result in a larger increase in body weight compared to the pecan SUB and control groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants in this group avoid all nuts for 8 weeks. |
| Pecan ADD | Experimental | Dietary Supplement: Pecan ADDParticipants in this group consume 68 g of pecans/d with no additional dietary instructions and avoid all other nuts. |
| Pecan SUB | Experimental | Dietary Supplement: Pecan SUBParticipants in this group consume 68 g of pecans/d with instructions to substitute pecans with isocaloric foods in the habitual diet. They are also instructed to avoid all other nuts. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ages 30-75y with higher cholesterol levels or BMI of 28 kg/m2 or greater (A higher cholesterol level is indicated by "Borderline High/Undesirable" in two or more of the variables (total cholesterol 200-239 mg/dL, LDL cholesterol 130-159 mg/dL, triglycerides 150-199 mg/dL) or "High" in either total cholesterol (240 mg/dL and higher) or LDL (160 mg/dL or higher).
Key exclusion criteria (22 listed)
- Familial hypercholesterolemia (individuals with LDL levels greater than the 95th percentile or HDL levels lower than the 20th percentile based on age and sex)
- Nut consumption >2 servings/week or tree nut butter consumption >3 servings/week
- Hormone replacement therapy <5 years
- Women who are pregnant or planning to become pregnant
- Regular exercise of >3 hours/week
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 |
|---|---|---|
| Pecan ADDAlso: PecanRaw pecan halves without dietary substitution instructions | Dietary supplement | Pecan ADD |
| Pecan SUBAlso: PecanRaw pecan halves with instructions to substitute pecans with isocaloric foods in the habitual diet | Dietary supplement | Pecan SUB |
Primary outcome
Change in baseline fasting blood lipids at 4 weeks and 8 weeks
Time frame: Baseline, 4 weeks, 8 weeks
Total cholesterol (mg/dL), high-density lipoprotein (HDL) cholesterol (mg/dL), triglycerides (mg/dL), low-density lipoprotein (LDL) cholesterol (mg/dL), non-HDL cholesterol (mg/dL), apolipoprotein B (mg/dL)
Change in baseline lipoprotein(a), lipoprotein particle number, and lipoprotein size at 4 and 8 weeks
Time frame: Baseline, 4 weeks, 8 weeks
Low-density lipoprotein (LDL) particle number (nmol/L), LDL small (nmol/L), LDL medium (nmol/L), HDL large (nmol/L), lipoprotein(a) (nmol/L)
Change in baseline low-density lipoprotein (LDL) peak size at 4 and 8 weeks
Time frame: Baseline, 4 weeks, 8 weeks
LDL peak size (angstrom)
Change in baseline weight at 4 and 8 weeks
Time frame: Baseline, 4 weeks, 8 weeks
Weight (kg)
Change in baseline waist and hip circumference at 4 and 8 weeks
Time frame: Baseline, 4 weeks, 8 weeks
waist and hip circumference (cm)
Change in baseline total body fat percentage at 4 and 8 weeks
Time frame: Baseline, 4 weeks, 8 weeks
Total body fat percentage (%)
11 secondary outcomes
Change in fasting and postprandial peptide YY, cholecystokinin (CCK), and ghrelin from baseline to 8 weeks
Time frame: Data will be collected at fasting at baseline, 4 weeks and 8 weeks. Postprandial data will be collected at baseline and 8 weeks.
Change in fasting and postprandial glucose and triglycerides from baseline to 8 weeks
Time frame: Data will be collected at fasting at baseline, 4 weeks and 8 weeks. Postprandial data will be collected at baseline and 8 weeks.
Change in fasting and postprandial non-esterified free fatty acids (NEFA) from baseline to 8 weeks
Time frame: Data will be collected at fasting at baseline, 4 weeks and 8 weeks. Postprandial data will be collected at baseline and 8 weeks.
Change in fasting and postprandial insulin from baseline to 8 weeks
Time frame: Data will be collected at fasting at baseline, 4 weeks and 8 weeks. Postprandial data will be collected at baseline and 8 weeks.
Change in resting metabolic rate (RMR) from baseline to 8 weeks
Time frame: Baseline and 8 weeks
Change in diet induced thermogenesis (DIT) from baseline to 8 weeks
Time frame: Baseline and 8 weeks
Change in fasting and postprandial carbohydrate and fat oxidation from baseline to 8 weeks
Time frame: Measured at fasting and for 3.5h postprandially at baseline and 8 weeks
Change in diet respiratory exchange ratio (RER) from baseline to 8 weeks
Time frame: Measured at fasting and for 3.5h postprandially at baseline and 8 weeks
Change in fasting and postprandial lipid peroxidation from baseline to 8 weeks
Time frame: Measured at fasting and for 4 hours postprandially at baseline and 8 weeks
Change in fasting and postprandial total antioxidant capacity from baseline to 8 weeks
Time frame: Measured at fasting and for 4 hours postprandially at baseline and 8 weeks
Changes in fasting and postprandial hunger and satiety from baseline to 8 weeks
Time frame: Measured at fasting and for 4 hours postprandially at baseline and 8 weeks. Also, measured once per hour after the baseline and 8-week visits.
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 1 Jun 2022.
- Derived from this study: PubMed 34383903Guarneiri LL, Paton CM, Cooper JA. Pecan-Enriched Diets Alter Cholesterol Profiles and Triglycerides in Adults at Risk for Cardiovascular Disease in a Randomized, Controlled Trial. J Nutr. 2021 Oct 1;151(10):3091-3101. doi: 10.1093/jn/nxab248.
- Individual participant dataSharing planned: No. The plan is to share group averages through publication.
Related trials for Hypercholesterolemia
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RecruitingObservational study
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Hypercholesterolemia, Atherosclerosis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pecan ADD and Pecan SUB in people with Hypercholesterolemia and Obesity, run by University of Georgia 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 1 inclusion and 22 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 1 Jun 2022. 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 baseline fasting blood lipids at 4 weeks and 8 weeks (time frame: Baseline, 4 weeks, 8 weeks). The study lists 6 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 NCT04376632, 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 1 Jun 2022.