Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT07151105

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 50 Years

SexAll

Healthy volunteersNot accepted

ConditionAdequate Vitamin C Status, Inadequate Vitamin C Status

Full registry criteria

Inclusion Criteria: * English speaking * Men and women between 18-50 years of age * BMI 30-40 kg/m² * Resting blood pressure \<140/90 mm Hg * No use of multivitamin/vitamin C supplement within past 1-month * Non-vegetarian/non-vegan * Willingness to follow a diet low in fruits and vegetables for two, 2-week periods Exclusion Criteria: * Current smoker or vaper, including tobacco, cannabis, or nicotine products * Alcohol consumption \>2 drinks/day * Use of antibiotics within past 1-month * Use of probiotic supplements within past 1-month * Use of anti-inflammatory drugs within past 1-month * Individuals with unmanaged or poorly controlled diabetes, dyslipidemia, hypertension * Known history of bleeding disorders, hemochromatosis, or kidney stones * For Women: Pregnancy, lactation, or change in birth control within the past 3-months * Use of certain medications that may interact with vitamin C, including blood thinners, some antiviral drugs (e.g., indinavir), and certain antipsychotic medications (e.g., fluphenazine).

Treatments and study arms

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.

Primary outcomes

Small Intestinal PermeabilityBetween-treatment arm comparison on day 14 following 2-week intervention.

Urinary excretion ratio of lactulose/mannitol following oral ingestion of these sugar probes.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

The Ohio State University🇺🇸 Columbus, Ohio, United States

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