Diets Enriched With Pecans

NCT04376632 | Completed

• 1 other identifier: STUDY00005985
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypercholesterolemia; Obesity

Outcome Measures

Primary Outcomes (6)

• 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)

  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)

  Baseline, 4 weeks, 8 weeks

• Change in baseline low-density lipoprotein (LDL) peak size at 4 and 8 weeks

  LDL peak size (angstrom)

  Baseline, 4 weeks, 8 weeks

• Change in baseline weight at 4 and 8 weeks

  Weight (kg)

  Baseline, 4 weeks, 8 weeks

• Change in baseline waist and hip circumference at 4 and 8 weeks

  waist and hip circumference (cm)

  Baseline, 4 weeks, 8 weeks

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

  Total body fat percentage (%)

  Baseline, 4 weeks, 8 weeks

Secondary Outcomes (11)

• Change in fasting and postprandial peptide YY, cholecystokinin (CCK), and ghrelin from baseline to 8 weeks

  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

  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

  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

  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

  Baseline and 8 weeks

Other Outcomes (1)

• Change in baseline perceived stress at 4 and 8 weeks

  Baseline, 4 weeks, 8 weeks

Study Arms (3)

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.

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.

Dietary Supplement: Pecan SUB

Interventions

Pecan ADD DIETARY_SUPPLEMENT

Raw pecan halves without dietary substitution instructions

Also known as: Pecan

Pecan ADD

Pecan SUB DIETARY_SUPPLEMENT

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

Also known as: Pecan

Pecan SUB

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Georgia: lead
• Georgia Pecan Commission: collaborator

Study Sites (1)

University of Georgia- Department of Foods and Nutrition

Athens, Georgia, 30605, United States

Location

Related Publications (1)

• 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.

  PMID: 34383903 DERIVED

MeSH Terms

Conditions

Hypercholesterolemia; Obesity

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are unaware that there are 2 pecan groups (with and without dietary substitution instructions)
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Dept. of Foods and Nutrition

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: May 6, 2020
• Study Start: August 10, 2018
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: June 1, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)