34 Participants Needed

Vitamin C for Gut Health in Obesity

SC
Overseen ByStudy Coordinator

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if daily vitamin C intake can improve gut health and reduce inflammation in adults with obesity. Poor gut health can allow harmful substances into the bloodstream, leading to inflammation and potentially increasing the risk of heart and liver problems. Participants will take vitamin C during one period and a placebo (a look-alike pill with no active ingredient) during another, while researchers assess gut health through various tests. Individuals with obesity (BMI between 30-40) who are willing to follow a diet low in fruits and vegetables for two weeks at a time might be suitable candidates. Participants may not benefit directly, but their involvement will help determine if vitamin C is an effective treatment for improving gut health in obesity. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on vitamin C's potential benefits for gut health.

Do I have to stop taking my current medications for the trial?

You may need to stop taking certain medications that can interact with vitamin C, like blood thinners, some antiviral drugs, and certain antipsychotic medications. The trial does not specify other medications, so it's best to discuss your current medications with the study team.

Is there any evidence suggesting that taking vitamin C is safe for improving gut health in adults with obesity?

Research shows that vitamin C is generally safe when taken in recommended amounts. Studies suggest that high doses of vitamin C for two weeks can positively affect gut bacteria, indicating that it is usually well-tolerated by healthy individuals.

Vitamin C, available without a prescription, often supports immune health. The FDA has approved it for general use, which adds confidence in its safety.

Some mild side effects may include an upset stomach or diarrhea, especially at very high doses. These effects are usually temporary and resolve on their own.

Overall, vitamin C appears to be a safe choice for most people, including those with obesity, when used as directed.12345

Why are researchers excited about this trial?

Researchers are excited about using Vitamin C for gut health in obesity because it offers a natural approach that could enhance gut function without the need for pharmaceuticals. Unlike standard treatments that focus on medication or dietary changes alone, Vitamin C supplementation works by potentially improving gut health through its antioxidant properties. This method might offer a safer, more holistic way to address gut health issues related to obesity, which is why there's a lot of interest in its potential benefits.

What evidence suggests that vitamin C might be an effective treatment for gut health in obesity?

This trial will compare the effects of different vitamin C levels on gut health in individuals with obesity. Studies have shown that vitamin C can impact gut health by altering the balance of gut bacteria. High doses of vitamin C taken for two weeks have led to positive changes in the gut bacteria of healthy individuals. Some research suggests that vitamin C might help reduce inflammation, which is often elevated in people with obesity. However, studies involving individuals with obesity have found only small or no significant improvements in gut health. Additionally, higher blood levels of vitamin C have been linked to a lower risk of liver disease. Overall, while vitamin C shows promise, its effects on gut health, particularly in people with obesity, remain unproven.56789

Who Is on the Research Team?

RB

Richard Bruno, PhD, RD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

Adults aged 18-50 with obesity (BMI 30-40), non-vegetarian/non-vegan, who speak English and have normal blood pressure. They must not have taken vitamin C supplements in the past month and be willing to eat a diet low in fruits and vegetables for the study duration.

Inclusion Criteria

My blood pressure is below 140/90 mm Hg.
I haven't taken multivitamins or vitamin C in the last month.
I include animal products in my diet.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Period 1

Participants receive either vitamin C or placebo for 2 weeks, with assessments on Days 0, 7, and 14

2 weeks
3 visits (in-person)

Washout

Participants undergo a 2-week washout period between treatment periods

2 weeks

Treatment Period 2

Participants receive the alternate treatment (vitamin C or placebo) for 2 weeks, with assessments on Days 0, 7, and 14

2 weeks
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Vitamin C
Trial Overview The trial is examining if daily vitamin C supplementation can improve gut health by reducing inflammation compared to a placebo. Participants will alternate between taking vitamin C and a placebo over two-week periods, with breaks in between, while their diet, activity, gut permeability, and biological samples are monitored.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Adequate Vitamin C StatusExperimental Treatment1 Intervention
Group II: Inadequate Vitamin C StatusPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials
891
Recruited
2,659,000+

Citations

Vitamins, Gut Microbiome & GI Health in HumansIn this review, we discuss the effects of vitamins on the gut microbiome, and related gastrointestinal health, based on in vitro, animal and human studies.
Vitamin C Supplementation in Healthy Individuals Leads to ...High-dose vitamin C supplementation for two weeks shows microbiota-modulating effects in healthy individuals, with several beneficial shifts of bacterial ...
Anti-inflammatory Activities of Vitamin C Supplementation ...Overview. This study is testing whether taking vitamin C every day can help improve gut health and reduce inflammation in adults with obesity.
Vitamin C Pharmacology & Health/Obesity ReviewRandomized trials assessing the effect of vitamin C supplementation in patients with obesity have found modest or no overall improvements in ...
Vitamin C in Gastrointestinal Function and DisordersA cross-sectional study of 4500 participants found that serum vitamin C levels of 50.5-67.0 µmol/L were associated with reduced liver disease risk whereas serum ...
The relationship between vitamin C status, the gut-liver axis ...Poor vitamin C status promotes endotoxemia, leading to metabolic dysfunction that impairs vitamin E trafficking through a mechanism involving the gut-liver ...
A Systematized Review of the Relationship Between ...Studies in children found that higher vitamin C intakes were associated with obesity. In an analysis of NHANES III data of 12–16-y-old boys and girls, boys who ...
Vitamin C | Linus Pauling Institute | Oregon State UniversityIn the Swedish Mammography Cohort, overweight women who consumed an average of 110 mg/day of vitamin C had a 39% lower risk of breast cancer compared to ...
Vitamin C Supplementation in Healthy Individuals Leads to ...High-dose vitamin C supplementation for two weeks shows microbiota-modulating effects in healthy individuals, with several beneficial shifts of bacterial ...
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