Clinical trial
Effects of Grape Consumption on the Immune-Gut Axis in Obesity
Recruiting now · Not applicable · 1 countries · Registry ID NCT07231484
Recruiting nowNot applicableInterventional
What this study is about
This study is investigating the benefits of whole freeze-dried grape powder consumption on the immune-gut axis in adults with obesity.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 60 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity &Amp; Overweight
Full registry criteria
Inclusion Criteria: * Age: 18-60 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 * 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
Treatments and study arms
Freeze-dried grape powder
Other
48 g/day oral consumption during the 4-week active period.
Placebo powder
Other
Isocaloric placebo matched to grape powder; oral consumption during the 4-week active period.
Primary outcomes
Gut microbial diversityBaseline, Week 4, Week 8, Week 12
Assessed via 16s rRNA sequencing
LPS-binding protein concentrationBaseline, Week 4, Week 8, Week 12
Intestinal permeability marker
Cytokine concentrations following PBMC stimulationBaseline, Week 4, Week 12
IL-6, IL-10
Perceived stress scoreBaseline, Week 4, Week 8, Week 12
Assessed using validated Cohen's Perceived Stress Scale. Scores range from 0-56 with higher scores indicating greater stress perceptions.
Study locations
1 locations were listed when this page was built. The first 40 are shown.
University of Missouri-Columbia🇺🇸 Columbia, Missouri, United States
Caitlyn Winn, MSContact
Jaapna Dhillon, PhDPrincipal Investigator
Caitlyn Winn, MSSub Investigator