Cardiometabolic Effects of the Recommended Daily Pecan Intake Dose

NCT07696403 | Not Yet Recruiting

• 1 other identifier: PROJECT00014754
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiovascular disease risk factors, including higher BMIs and poor cholesterol profiles, are on the rise and contribute to the United States' growing disease burden. The bioactive compounds contained in tree nuts have been shown to beneficially affect cardiometabolic health outcomes. Pecans contain more total phenols, sterols, and flavonoids than any other tree nut. They also are a rich source of polyunsaturated fatty acids (PUFAs), fiber, vitamin A, vitamin E, folic acid, calcium, magnesium, phosphorus, potassium, and zinc. These bioactive components in pecans are likely the reason for the previously documented improvements in cardiometabolic health. This study aims to examine the impact of a low dose of pecans on changes in fasting and postprandial lipid metabolism/blood lipids and markers of chronic disease risk. The specific aims of this study are to:

• Examine the effect of pecan consumption at a dose of 6% of total energy needs for 12 weeks on fasting and postprandial blood lipids.
• Examine the effect of pecan consumption at a dose of 6% of total energy needs for 12 weeks on other markers of chronic disease risk. Participants will be asked to:
• Consume pecans daily for 12 weeks or maintain their current habitual diet.
• Attend two short visits at 4 and 8 weeks for fasting blood draws, body measurements, and to collect their next 4 weeks' supply of study materials.
• Attend two longer (5 h) testing visits, which include eating a standard breakfast meal and having their blood drawn periodically before and after breakfast. Researchers will compare the Pecan and Control groups to examine the physiologic effects of incorporating a low dose of pecans into one's diet.

Conditions

Nutrition, Healthy; Dyslipidemia; Overweight and Obesity

Outcome Measures

Primary Outcomes (7)

• Change in fasting serum lipoprotein and cholesterol concentrations

  The concentration of fasting serum total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, oxidized low-density lipoprotein cholesterol, cholesterol/HDL ratio, and non-HDL cholesterol (mg/dL)

  baseline, 12 weeks

• Change in fasting and postprandial plasma triglyceride concentrations

  The concentration of plasma triglycerides before and after the high saturated fat meal challenge at both pre-and post-intervention visits (mg/dL)

  baseline, 12 weeks

• Change in fasting and postprandial plasma non-esterified fatty acid (NEFA) concentrations

  The concentration of plasma NEFAs before and after the high saturated fat meal challenge at both pre- and post-intervention visits (mEq/L)

  baseline, 12 weeks

• Change in fasting and postprandial plasma appetite control hormone concentrations

  The concentration of plasma appetite control hormones before and after the high saturated fat meal challenge at both pre- and post-intervention visits. Appetite control hormones include cholecystokinin (CCK), Peptide YY (PYY), and Ghrelin (pg/mL)

  baseline, 12 weeks

• Change in fasting and postprandial subjective feelings related to appetite

  Visual analog scale ratings of feelings related to appetite before and after the high saturated fat meal challenge, and for the remainder of the day, at both pre- and post-intervention visits. Subjective feelings of hunger, fullness, desire to eat, prospective consumption, and a composite appetite score are measured by visual analog scales (mm).

  baseline, 12 weeks

• Change in fasting and postprandial plasma Malondialdehyde (MDA)

  The concentration of MDA before and after the high saturated fat meal challenge at both pre- and post-intervention visits (nmol/mL).

  baseline, 12 weeks

• Change in fasting and postprandial plasma total antioxidant capacity

  Total antioxidant capacity before and after the high saturated fat meal challenge at both pre- and post-intervention visits (U/mL).

  baseline, 12 weeks

Secondary Outcomes (11)

• Change in fasting serum hepatic enzymes

  baseline, 12 weeks

• Change in fasting serum hepatic proteins

  baseline, 12 weeks

• Change in fasting serum bilirubin

  baseline, 12 weeks

• Change in fasting and postprandial plasma insulin concentrations

  baseline, 12 weeks

• Change in fasting and postprandial plasma glucose concentrations

  baseline, 12 weeks

Other Outcomes (14)

• Change in blood pressure

  baseline, 12 weeks

• Change in body weight

  baseline, 12 weeks

• Change in body composition

  baseline, 12 weeks

Study Arms (2)

Pecan

EXPERIMENTAL

Participants are given pecans and instructed on how to substitute study foods into their diet to maintain caloric balance.

Other: Pecan

Control

EXPERIMENTAL

Participants are asked to maintain their current habitual diet and to avoid any tree nut/peanut consumption and limit nut butters to no more than twice per week for the entire 12-week intervention period.

Other: Control

Interventions

Pecan OTHER

Participants are provided with a quantity of pecans that delivers 6% of the participant's estimated energy needs for 12 weeks.

Pecan

Control OTHER

Participants are asked to maintain their current habitual diet and to avoid any tree nut/peanut consumption and limit nut butters to no more than twice per week for the entire 12-week intervention period.

Control

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• year-old men and women at increased risk for cardiovascular disease. Increased risk for cardiovascular disease will be defined by either elevated cholesterol profiles -or- overweight/obesity.
• Elevated cholesterol profiles will be defined as:
• "Borderline High" and/or "at risk" in two or more of the following variables (total cholesterol: 180-239 mg/dL, LDL cholesterol 110-159 mg/dL, triglycerides 130-199 mg/dL) --or-- "High" in total cholesterol (240 mg/dL and higher), LDL (160 mg/dL or higher), or triglycerides (between 200-350 mg/dL).
• Overweight/obesity will be defined by body mass index (overweight \> 28 kg/m2 or obesity 30 kg/m2 or greater).

You may not qualify if:

• Probable familial hypercholesterolemia, defined by: total cholesterol greater than 290 mg/dL or LDL levels greater than 190 mg/dL plus a family history of myocardial infarction (MI) before 50 years of age in a 2nd-degree relative or below age 60 in a 1st-degree relative.
• Women on hormone replacement therapy less than 2 years.
• Women who are pregnant or nursing
• Individuals who regularly exercise more than 3h/w
• Weight gain or loss of more than 5% body weight in the past 3 months
• Plans to begin a weight loss/exercise regimen during the trial
• History of medical or surgical events that could affect digestion or swallowing
• Gastrointestinal surgeries, conditions, or disorders
• Any chronic diseases (including moderate to severe asthma, chronic lung disease, and kidney disease)
• Metabolic disease
• Atherosclerosis
• Previous MI or stroke
• Cancer
• Fasting blood glucose levels greater than 126 mg/dL
• Blood pressure greater than 180/120 mmHg

Sponsors & Collaborators

• University of Georgia: lead

Study Sites (1)

University of Georgia

Athens, Georgia, 30602, United States

Location

MeSH Terms

Conditions

Dyslipidemias; Overweight; Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Jamie A Cooper, PhD

  University of Georgia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jamie A Cooper, PhD

CONTACT

706-542-4378; jamie.cooper@uga.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are blinded from which group they are in.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department Head of Kinesiology, Director of UGA Obesity Initiative

Model Details: Two groups of 12-week parallel feeding trials, with one group receiving 6% of energy needs from pecans and one group serving as Control (instructed to maintain their current habitual diet).

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 10, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: July 13, 2026

Record last verified: 2026-07

Locations

US (1)