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Effect of Colon Delivered Vitamin C on Gut Microbiota and Related Health Biomarkers in Healthy Older Adults

NCT05598619 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2024-08-22

No results posted yet for this study

Summary

Recent studies have shown that many vitamins, if consumed in high daily dosages or delivered to the colon, can modulate the gut microbiota and their metabolites. In parallel, gut microbiota imbalances are linked to diseases, e.g., obesity, type 2 diabetes, cardiovascular disease, autoimmune diseases, and intestinal inflammatory diseases. Therefore, vitamin administration could offer health benefits beyond those traditionally considered for these nutrients. Earlier, our group investigated the effect of colon-delivered vitamins A, B2, C, D, and E on the gut microbiota using a human clinical trial and showed that vitamin C, B2, and D modulates the human gut microbiome in terms of metabolic activity and bacterial composition. The most distinct effect was that of vitamin C, which significantly increased microbial alpha diversity and fecal short-chain fatty acids compared to the placebo. However, the dose-dependent and combined effect of colon-delivered vitamins on the microbial community and its subsequent impact on host health is unknown. This study will investigate the effect of colon-delivered vitamin C (three dosages) on the gut microbiome.

Conditions

  • Quality of Life

Interventions

DIETARY_SUPPLEMENT

Vitamin C

Colon delivered vitamin C (ascorbic acid) for 12 weeks

OTHER

placebo

Colon delivered placebo once a day for 12 weeks

Sponsors & Collaborators

  • Atlantia Food Clinical Trials

    collaborator INDUSTRY

  • DSM Nutritional Products, Inc.

    lead INDUSTRY

Principal Investigators

  • Prof Timothy Dinan · Cork University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2023-03-13
Completion
2023-03-13

Countries

  • Ireland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05598619 on ClinicalTrials.gov