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Diets Enriched With Pecans

Primary Purpose

Hypercholesterolemia, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pecan ADD
Pecan SUB
Sponsored by
University of Georgia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hypercholesterolemia

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • University of Georgia- Department of Foods and Nutrition

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control

Pecan ADD

Pecan SUB

Arm Description

Participants in this group avoid all nuts for 8 weeks.

Participants in this group consume 68 g of pecans/d with no additional dietary instructions and avoid all other nuts.

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.

Outcomes

Primary Outcome Measures

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)
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)
Change in baseline low-density lipoprotein (LDL) peak size at 4 and 8 weeks
LDL peak size (angstrom)
Change in baseline weight at 4 and 8 weeks
Weight (kg)
Change in baseline waist and hip circumference at 4 and 8 weeks
waist and hip circumference (cm)
Change in baseline total body fat percentage at 4 and 8 weeks
Total body fat percentage (%)

Secondary Outcome Measures

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)
Change in fasting and postprandial glucose and triglycerides from baseline to 8 weeks
Glucose (mg/dL) and triglycerides (mg/dL)
Change in fasting and postprandial non-esterified free fatty acids (NEFA) from baseline to 8 weeks
NEFA (mEq/L)
Change in fasting and postprandial insulin from baseline to 8 weeks
Insulin (uU/mL)
Change in resting metabolic rate (RMR) from baseline to 8 weeks
RMR (kcals/d) measured via indirect calorimetry
Change in diet induced thermogenesis (DIT) from baseline to 8 weeks
DIT (kcals) measured via indirect calorimetry
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
Change in diet respiratory exchange ratio (RER) from baseline to 8 weeks
RER measured via indirect calorimetry
Change in fasting and postprandial lipid peroxidation from baseline to 8 weeks
Malondialdehyde (MDA) (uM) measured via Thiobarbituric acid reactive substances (TBARS) assay.
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.
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.

Full Information

First Posted
April 30, 2020
Last Updated
May 27, 2022
Sponsor
University of Georgia
Collaborators
Georgia Pecan Commission
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1. Study Identification

Unique Protocol Identification Number
NCT04376632
Brief Title
Diets Enriched With Pecans
Official Title
Comparison of Health Effects of Diets With and Without Pecans
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
August 10, 2018 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
June 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Georgia
Collaborators
Georgia Pecan Commission

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia, Obesity

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Participants are unaware that there are 2 pecan groups (with and without dietary substitution instructions)
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants in this group avoid all nuts for 8 weeks.
Arm Title
Pecan ADD
Arm Type
Experimental
Arm Description
Participants in this group consume 68 g of pecans/d with no additional dietary instructions and avoid all other nuts.
Arm Title
Pecan SUB
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Pecan ADD
Other Intervention Name(s)
Pecan
Intervention Description
Raw pecan halves without dietary substitution instructions
Intervention Type
Dietary Supplement
Intervention Name(s)
Pecan SUB
Other Intervention Name(s)
Pecan
Intervention Description
Raw pecan halves with instructions to substitute pecans with isocaloric foods in the habitual diet
Primary Outcome Measure Information:
Title
Change in baseline fasting blood lipids at 4 weeks and 8 weeks
Description
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)
Time Frame
Baseline, 4 weeks, 8 weeks
Title
Change in baseline lipoprotein(a), lipoprotein particle number, and lipoprotein size at 4 and 8 weeks
Description
Low-density lipoprotein (LDL) particle number (nmol/L), LDL small (nmol/L), LDL medium (nmol/L), HDL large (nmol/L), lipoprotein(a) (nmol/L)
Time Frame
Baseline, 4 weeks, 8 weeks
Title
Change in baseline low-density lipoprotein (LDL) peak size at 4 and 8 weeks
Description
LDL peak size (angstrom)
Time Frame
Baseline, 4 weeks, 8 weeks
Title
Change in baseline weight at 4 and 8 weeks
Description
Weight (kg)
Time Frame
Baseline, 4 weeks, 8 weeks
Title
Change in baseline waist and hip circumference at 4 and 8 weeks
Description
waist and hip circumference (cm)
Time Frame
Baseline, 4 weeks, 8 weeks
Title
Change in baseline total body fat percentage at 4 and 8 weeks
Description
Total body fat percentage (%)
Time Frame
Baseline, 4 weeks, 8 weeks
Secondary Outcome Measure Information:
Title
Change in fasting and postprandial peptide YY, cholecystokinin (CCK), and ghrelin from baseline to 8 weeks
Description
Peptide YY (pg/mL), CCK (pg/mL) and ghrelin (pg/mL)
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.
Title
Change in fasting and postprandial glucose and triglycerides from baseline to 8 weeks
Description
Glucose (mg/dL) and triglycerides (mg/dL)
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.
Title
Change in fasting and postprandial non-esterified free fatty acids (NEFA) from baseline to 8 weeks
Description
NEFA (mEq/L)
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.
Title
Change in fasting and postprandial insulin from baseline to 8 weeks
Description
Insulin (uU/mL)
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.
Title
Change in resting metabolic rate (RMR) from baseline to 8 weeks
Description
RMR (kcals/d) measured via indirect calorimetry
Time Frame
Baseline and 8 weeks
Title
Change in diet induced thermogenesis (DIT) from baseline to 8 weeks
Description
DIT (kcals) measured via indirect calorimetry
Time Frame
Baseline and 8 weeks
Title
Change in fasting and postprandial carbohydrate and fat oxidation from baseline to 8 weeks
Description
Carbohydrate oxidation (g) and fat oxidation (g) measured via indirect calorimetry
Time Frame
Measured at fasting and for 3.5h postprandially at baseline and 8 weeks
Title
Change in diet respiratory exchange ratio (RER) from baseline to 8 weeks
Description
RER measured via indirect calorimetry
Time Frame
Measured at fasting and for 3.5h postprandially at baseline and 8 weeks
Title
Change in fasting and postprandial lipid peroxidation from baseline to 8 weeks
Description
Malondialdehyde (MDA) (uM) measured via Thiobarbituric acid reactive substances (TBARS) assay.
Time Frame
Measured at fasting and for 4 hours postprandially at baseline and 8 weeks
Title
Change in fasting and postprandial total antioxidant capacity from baseline to 8 weeks
Description
Total antioxidant capacity (uM trolox equivalents) measured via Oxygen Radical Absorbance Capacity (ORAC) assay.
Time Frame
Measured at fasting and for 4 hours postprandially at baseline and 8 weeks
Title
Changes in fasting and postprandial hunger and satiety from baseline to 8 weeks
Description
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.
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.
Other Pre-specified Outcome Measures:
Title
Change in baseline perceived stress at 4 and 8 weeks
Description
The perceived stress scale (PSS) measures stress over the last 4 weeks on a scale from 0-40. Low scores indicate low stress. A score of 13 is average. Scores of 20 or greater are considered to be high stress.
Time Frame
Baseline, 4 weeks, 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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 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
Facility Information:
Facility Name
University of Georgia- Department of Foods and Nutrition
City
Athens
State/Province
Georgia
ZIP/Postal Code
30605
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The plan is to share group averages through publication.
Citations:
PubMed Identifier
34383903
Citation
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.
Results Reference
derived

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Diets Enriched With Pecans

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