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Recruiting NCT07231484

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

No phase Interventional Obesity &Amp; Overweight

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Freeze-dried grape powder, Placebo powder.
Who it may be relevant to
Registry conditions: Obesity &Amp; Overweight. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effects of Grape Consumption on Immune and Gut Health in the Setting of Obesity

Overview

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

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.

Interventions

  • 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.

Primary outcome measures

  • 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]
Secondary outcome measures (12)
  • Gut microbiome abundance [Time frame: Baseline, Week 4, Week 8, Week 12]
  • Inflammatory Markers [Time frame: Baseline, Week 4, Week 8, Week 12]
  • Body mass [Time frame: Baseline, Week 4, Week 8, Week 12]
  • Body composition [Time frame: Baseline, Week 4, Week 8, Week 12]
  • Anthropometrics [Time frame: Baseline, Week 4, Week 8, Week 12]
  • Glucoregulation [Time frame: Baseline, Week 4, Week 8, Week 12]
  • Insulinemic biomarker concentrations [Time frame: Baseline, Week 4, Week 8, Week 12]
  • Lipid profile [Time frame: Baseline, Week 4, Week 8, Week 12]
  • Blood pressure [Time frame: Baseline, Week 4, Week 8, Week 12]
  • Dietary intake using 24-hour recalls [Time frame: Every week]
  • Physical activity [Time frame: Baseline, Week 4, Week 8, Week 12]
  • Sleep indices from Actigraphs [Time frame: Baseline, Week 4, Week 8, Week 12]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Missouri-Columbia — Columbia

Identifiers

NCT: NCT07231484 · 2128808

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗