Trials / Completed
CompletedNCT04376632
Diets Enriched With Pecans
Comparison of Health Effects of Diets With and Without Pecans
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 124 (actual)
- Sponsor
- University of Georgia · Academic / Other
- Sex
- All
- Age
- 30 Years – 75 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Pecan ADD | Raw pecan halves without dietary substitution instructions |
| DIETARY_SUPPLEMENT | Pecan SUB | Raw pecan halves with instructions to substitute pecans with isocaloric foods in the habitual diet |
Timeline
- Start date
- 2018-08-10
- Primary completion
- 2021-06-01
- Completion
- 2021-06-01
- First posted
- 2020-05-06
- Last updated
- 2022-06-01
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04376632. Inclusion in this directory is not an endorsement.