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_SUPPLEMENTParticipants 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_SUPPLEMENTParticipants 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 StatusPlacebo + Low Vitamin C Diet
- Experimental: Adequate Vitamin C StatusVitamin 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
- Study Coordinator614-292-4751
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| The Ohio State University | Columbus | Ohio | 43210 | - |