Anti-inflammatory Activities of Vitamin C Supplementation on the Gut Barrier Function in Adults With Obesity

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University
Study ID
NCT07151105
Status
Recruiting

Conditions

  • Adequate Vitamin C Status
  • Inadequate Vitamin C Status

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Vitamin C Supplement + Low Vitamin C Diet — DIETARY_SUPPLEMENT
    Participants will receive a vitamin C supplement (1000 mg/d) while following a low vitamin C diet to achieve adequate vitamin C status in a blinded manner. This will be compared to participants receiving a placebo while following a low vitamin C diet that is expected to maintain inadequate vitamin C status.
  • Placebo + Low Vitamin C Diet — DIETARY_SUPPLEMENT
    Participants will receive a placebo while following a low vitamin C diet to achieve inadequate vitamin C status in a blinded manner. This will be compared to participants receiving a vitamin C supplement while following a low vitamin C diet that is expected to maintain adequate vitamin C status.

Study Details

This study is testing whether taking vitamin C every day can help improve gut health and reduce inflammation in adults with obesity. Poor gut health-sometimes called "leaky gut"-can allow harmful substances from bacteria to enter the bloodstream, which may lead to inflammation and increase the risk of heart disease and liver problems. Participants will complete two study periods, each lasting two weeks, with a two-week break in between. In one period, they will take vitamin C; in the other, a placebo. During each period, researchers will collect blood, urine, and stool samples, ask participants to track their diet and activity, and perform a test to measure gut permeability. There are minimal risks, such as discomfort from blood draws or temporary stomach upset from a sugar drink. While participants may not directly benefit, their involvement will help researchers learn whether vitamin C is a safe and effective way to improve gut health in people with obesity.

Key Dates

Start date
Oct 1, 2025
Status verified
Oct 2025
Primary completion
Jun 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
34 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Placebo Comparator: Inadequate Vitamin C Status
    Placebo + Low Vitamin C Diet
  • Experimental: Adequate Vitamin C Status
    Vitamin C Supplement + Low Vitamin C Diet

Primary Outcome Measure

Small Intestinal Permeability [ Time Frame: Between-treatment arm comparison on day 14 following 2-week intervention. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Ohio State UniversityColumbusOhio43210-

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