Effects of Grape Consumption on the Immune-Gut Axis in Obesity

NCT07231484 | Recruiting

• 1 other identifier: 2128808
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

Obesity; Immunity; Microbiome; Gut; Grape; Stress

Outcome Measures

Primary Outcomes (4)

• Gut microbial diversity

  Assessed via 16s rRNA sequencing

  Baseline, Week 4, Week 8, Week 12

• LPS-binding protein concentration

  Intestinal permeability marker

  Baseline, Week 4, Week 8, Week 12

• Cytokine concentrations following PBMC stimulation

  IL-6, IL-10

  Baseline, Week 4, Week 12

• Perceived stress score

  Assessed using validated Cohen's Perceived Stress Scale. Scores range from 0-56 with higher scores indicating greater stress perceptions.

  Baseline, Week 4, Week 8, Week 12

Secondary Outcomes (18)

• Gut microbiome abundance

  Baseline, Week 4, Week 8, Week 12

• Inflammatory Markers

  Baseline, Week 4, Week 8, Week 12

• Body mass

  Baseline, Week 4, Week 8, Week 12

• Body composition

  Baseline, Week 4, Week 8, Week 12

• Anthropometrics

  Baseline, Week 4, Week 8, Week 12

Other Outcomes (2)

• Memory indices

  Baseline, Week 4, Week 8, Week 12

• Attention indices

  Baseline, Week 4, Week 8, Week 12

Study Arms (2)

Sequence 1: Grape then Placebo

EXPERIMENTAL

Whole freeze-dried grape powder for 4 weeks, 4-week washout, then isocaloric placebo powder for 4 weeks.

Other: Freeze-dried grape powder; Other: Placebo powder

Sequence 2: Placebo then Grape

EXPERIMENTAL

Isocaloric placebo powder for 4 weeks, 4-week washout, then whole freeze-dried grape powder for 4 weeks.

Other: Freeze-dried grape powder; Other: Placebo powder

Interventions

Freeze-dried grape powder OTHER

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

Sequence 1: Grape then Placebo; Sequence 2: Placebo then Grape

Placebo powder OTHER

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

Sequence 1: Grape then Placebo; Sequence 2: Placebo then Grape

Eligibility Criteria

• Age: 30 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Missouri-Columbia: lead
• California Table Grape Commission: collaborator

Study Sites (1)

University of Missouri-Columbia

Columbia, Missouri, 65211, United States

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jaapna Dhillon PhD, PhD

CONTACT

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

Caitlyn Winn, MS

CONTACT

207-210-8049; cawq6x@umsystem.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: November 17, 2025
• Study Start: December 19, 2025
• Primary Completion (Estimated): December 20, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: December 30, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Data will be deposited in online repositories

Locations

US (1)