Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Hypercholesterolemia
  • Obesity
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Participant)Masking Description: Participants are unaware that there are 2 pecan groups (with and without dietary substitution instructions)Primary Purpose: Other

Participation Requirements

Age
Between 30 years and 75 years
Gender
Both males and females

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)...

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.

Tracking Information

NCT #
NCT04376632
Collaborators
Georgia Pecan Commission
Investigators
Not Provided