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OpenTrials
Completed

NCT Number: NCT04376632

Diets Enriched With 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.

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Key information

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Georgia- Department of Foods and Nutrition

Athens, Georgia, 30605, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pecan ADD

Dietary Supplement

Raw pecan halves without dietary substitution instructions

Other names: Pecan

Pecan SUB

Dietary Supplement

Raw pecan halves with instructions to substitute pecans with isocaloric foods in the habitual diet

Other names: Pecan

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. Change in baseline weight at 4 and 8 weeks

    Time frame: Baseline, 4 weeks, 8 weeks

    Weight (kg)

  5. Change in baseline waist and hip circumference at 4 and 8 weeks

    Time frame: Baseline, 4 weeks, 8 weeks

    waist and hip circumference (cm)

  6. Change in baseline total body fat percentage at 4 and 8 weeks

    Time frame: Baseline, 4 weeks, 8 weeks

    Total body fat percentage (%)

Secondary outcomes

  1. 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.

    Peptide YY (pg/mL), CCK (pg/mL) and ghrelin (pg/mL)

  2. 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.

    Glucose (mg/dL) and triglycerides (mg/dL)

  3. 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.

    NEFA (mEq/L)

  4. 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.

    Insulin (uU/mL)

  5. Change in resting metabolic rate (RMR) from baseline to 8 weeks

    Time frame: Baseline and 8 weeks

    RMR (kcals/d) measured via indirect calorimetry

  6. Change in diet induced thermogenesis (DIT) from baseline to 8 weeks

    Time frame: Baseline and 8 weeks

    DIT (kcals) measured via indirect calorimetry

  7. 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

    Carbohydrate oxidation (g) and fat oxidation (g) measured via indirect calorimetry

  8. 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

    RER measured via indirect calorimetry

  9. 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

    Malondialdehyde (MDA) (uM) measured via Thiobarbituric acid reactive substances (TBARS) assay.

  10. 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

    Total antioxidant capacity (uM trolox equivalents) measured via Oxygen Radical Absorbance Capacity (ORAC) assay.

  11. 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.

    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.

Other outcomes

  1. Change in baseline perceived stress at 4 and 8 weeks

    Time frame: Baseline, 4 weeks, 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Georgia

Other

Collaborators

  • Georgia Pecan Commission

Registry information

Official study title

Comparison of Health Effects of Diets With and Without Pecans

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
May 6, 2020
Registry last updated
Jun 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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