Diets Enriched With Pecans

NCT ID: NCT04376632

Last Updated: 2022-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-10
• Study Completion Date: 2021-06-01

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.

Conditions

Hypercholesterolemia; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Control

Participants in this group avoid all nuts for 8 weeks.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Pecan ADD

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

Group Type: EXPERIMENTAL

Pecan ADD

Intervention Type: DIETARY_SUPPLEMENT

Raw pecan halves without dietary substitution instructions

Pecan SUB

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.

Group Type: EXPERIMENTAL

Pecan SUB

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Pecan ADD

Raw pecan halves without dietary substitution instructions

Intervention Type: DIETARY_SUPPLEMENT

Pecan SUB

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Pecan; Pecan

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Georgia Pecan Commission

UNKNOWN

Sponsor Role: collaborator

University of Georgia

OTHER

Sponsor Role: lead

Responsible Party

Jamie Cooper, PhD

Associate Professor, Dept. of Foods and Nutrition

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Georgia- Department of Foods and Nutrition

Athens, Georgia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34383903 (View on PubMed)

Other Identifiers

STUDY00005985

Identifier Type: -

Identifier Source: org_study_id