Effects of Grape Consumption on the Immune-Gut Axis in Obesity
Purpose
This study is investigating the benefits of whole freeze-dried grape powder consumption on the immune-gut axis in adults with obesity.
Condition
- Obesity &Amp; Overweight
Eligibility
- Eligible Ages
- Between 30 Years and 45 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Age: 30-45 years - Obesity with BMI of 30-45 kg/m2 - Willingness to consume study foods - Consistent diet and activity patterns for 4 weeks - Weight stable (<5kg change over last 3 months) - Non-smoker > 1 year or more - Not currently consuming an extremely healthy diet
Exclusion Criteria
- Study food allergies - Regular consumption of grapes or grape-derived products - Gastrointestinal disease and/or bariatric surgery - Uncontrolled hypertension and blood pressure >180/110 - Diabetes - Clinical Depression - Illicit drug use - History of alcohol or drug abuse - Recent use of medications that affect immune function (e.g., corticosteroids) - Recent consumption of antibiotics, prebiotics, probiotics, symbiotics, or dietary supplements containing fiber or phytochemicals - Pregnant or lactating individuals - HIV positivity - Recent start of medications that affect metabolism or appetite - Drug therapy for coronary artery disease, peripheral artery disease, congestive heart failure, or dyslipidemia
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Sequence 1: Grape then Placebo |
Whole freeze-dried grape powder for 4 weeks, 4-week washout, then isocaloric placebo powder for 4 weeks. |
|
|
Experimental Sequence 2: Placebo then Grape |
Isocaloric placebo powder for 4 weeks, 4-week washout, then whole freeze-dried grape powder for 4 weeks. |
|
Recruiting Locations
University of Missouri-Columbia
Columbia, Missouri 65211
Columbia, Missouri 65211
More Details
- NCT ID
- NCT07231484
- Status
- Recruiting
- Sponsor
- University of Missouri-Columbia
Detailed Description
The study is a 12-wk randomized, controlled, crossover trial. Participants will be randomized to one of two intervention sequences, either consuming 48g/day of whole freeze-dried grape powder followed by an isocaloric placebo powder or consuming the placebo powder followed by the whole freeze-dried grape powder. Active intervention phases will be 4 weeks in duration followed by a 4-week washout period between treatments.