Recruiting

Grape Powder

Sponsor:

University of Missouri-Columbia

Code:

NCT07231484

Conditions

Obesity &Amp; Overweight

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Freeze-dried grape powder

Placebo powder

Study Details

Brief summary:

This study is investigating the benefits of whole freeze-dried grape powder consumption on the immune-gut axis in adults with obesity.

Conditions

Obesity &Amp; Overweight

Study ID

NCT07231484

Start date

Dec 19, 2025

Status verified date

Jul, 2026

Completion date

Dec 30, 2027

Anticipated

Primary completion date

Dec 20, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Freeze-dried grape powder

48 g/day oral consumption during the 4-week active period.

Placebo powder

Isocaloric placebo matched to grape powder; oral consumption during the 4-week active period.

Primary outcome measure

  • Gut microbial diversity [ Time Frame: Baseline, Week 4, Week 8, Week 12 ]
  • LPS-binding protein concentration [ Time Frame: Baseline, Week 4, Week 8, Week 12 ]
  • Cytokine concentrations following PBMC stimulation [ Time Frame: Baseline, Week 4, Week 12 ]
  • Perceived stress score [ Time Frame: Baseline, Week 4, Week 8, Week 12 ]

Central Contacts and Locations

Central contacts

Jaapna Dhillon PhD, PhD

573-884-2103jdhillon@health.missouri.edu

Caitlyn Winn, MS

207-210-8049cawq6x@umsystem.edu

Locations

University of Missouri-Columbia

Recruiting

Columbia, Missouri, United States, 65211

Contacts

Caitlyn Winn, MS

2072108049cawq6x@umsystem.edu

Principal Investigator:

Jaapna Dhillon, PhD

More Information

Sponsor

University of Missouri-Columbia

Last update posted

Jul 31, 2026

Last verified

Jul, 2026

Keywords

  • Obesity
  • Immunity
  • Microbiome
  • Gut
  • Grape
  • Stress

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Missouri-Columbia on 2026-07-31.