Trials Today

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.	Other: Freeze-dried grape powder 48 g/day oral consumption during the 4-week active period. Other: Placebo powder Isocaloric placebo matched to grape powder; oral consumption during the 4-week active period.
Experimental Sequence 2: Placebo then Grape	Isocaloric placebo powder for 4 weeks, 4-week washout, then whole freeze-dried grape powder for 4 weeks.	Other: Freeze-dried grape powder 48 g/day oral consumption during the 4-week active period. Other: Placebo powder Isocaloric placebo matched to grape powder; oral consumption during the 4-week active period.

Recruiting Locations

University of Missouri-Columbia
Columbia, Missouri 65211

Contact:
Caitlyn Winn, MS
207-210-8049
cawq6x@umsystem.edu

More Details

NCT ID: NCT07231484
Status: Recruiting
Sponsor: University of Missouri-Columbia

Study Contact

Jaapna Dhillon PhD, PhD
573-884-2103
jdhillon@health.missouri.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.