Anti-inflammatory Activities of Vitamin C Supplementation on the Gut Barrier Function in Adults With Obesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorOhio State University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
English speaking
Men and women between 18-50 years of age
BMI 30-40 kg/m²
Resting blood pressure <140/90 mm Hg
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
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.
Treatment groups
34 Participants
are divided into 2 treatment groupsGroup A: Inadequate Vitamin C StatusPlacebo comparator 1 intervention
Group B: Adequate Vitamin C StatusExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Small Intestinal Permeability
Urinary excretion ratio of lactulose/mannitol following oral ingestion of these sugar probes.
Time frame
Between-treatment arm comparison on day 14 following 2-week intervention.Secondary outcomes
1
Large Intestinal Permeability
Urinary excretion ratio of sucralose/erythritol following oral ingestion of these sugar probes.
Time frame
Between-treatment arm comparison on day 14 following 2-week intervention.2
Plasma Vitamin C
Biochemical measures of Vitamin C
Time frame
Between-treatment arm comparison on day 14 following 2-week intervention.3
Plasma Vitamin C
Biochemical measures of Vitamin C
Time frame
Within-treatment arm comparison from day 0 to day 14 following 2-week intervention.4
Fecal Calprotectin
Biochemical measures of Calprotectin
Time frame
Between-treatment arm comparison on day 14 following 2-week intervention.Other outcomes
1
alpha-Diversity (Chao1)
Gut microbiota alpha-diversity will be determined from 16S rRNA sequencing
Time frame
Between-treatment arm comparison on day 14 following 2-week intervention2
alpha-Diversity (Shannon Index)
Gut microbiota alpha-diversity will be determined from 16S rRNA sequencing
Time frame
Between-treatment arm comparison on day 14 following 2-week intervention3
beta-Diversity (Bray-Curtis Dissimilarity)
Gut microbiota beta-diversity will be determined from 16S rRNA sequencing
Time frame
Between-treatment arm comparison on day 14 following 2-week intervention4
beta-Diversity (UniFrac)
Gut microbiota beta-diversity will be determined from 16S rRNA sequencing
Time frame
Between-treatment arm comparison on day 14 following 2-week interventionSponsors and contacts
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Source ClinicalTrials.gov