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

NCT05598619 | Completed DMC

• 1 other identifier: 020-11-11-VITC
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

microbiota; vitamin; short chain fatty acids

Outcome Measures

Primary Outcomes (1)

• Microbial metabolites measured as short-chain fatty acid content in faeces, at baseline and at week 12.

  To assess the changes of microbial metabolites from baseline to 12 weeks supplementation of three different doses of colon delivered vitamin C to compare the changes to placebo.

  from baseline to 12 weeks

Secondary Outcomes (12)

• Faecal microbial composition and diversity

  from baseline to 12 weeks

• Intestinal inflammation

  from baseline to 12 weeks

• Intestinal barrier integrity

  from baseline to 12 weeks

• Oxidative stress in blood

  from baseline to 12 weeks

• Inflammatory status in blood

  from baseline to 12 weeks

Study Arms (4)

Low dose

EXPERIMENTAL

Daily dose of 80 mg Vitamin C (Ascorbic acid) once a day for 12 weeks

Dietary Supplement: Vitamin C

Mid dose

EXPERIMENTAL

Daily dose of 200 mg Vitamin C (Ascorbic acid) once a day for 12 weeks

Dietary Supplement: Vitamin C

High dose

EXPERIMENTAL

Daily dose of 500 mg Vitamin C (Ascorbic acid) once a day for 12 weeks

Dietary Supplement: Vitamin C

Placebo

PLACEBO COMPARATOR

One capsule of 570 mg (consisting microcrystalline cellulose) once a day for 12 weeks

Other: placebo

Interventions

Vitamin C DIETARY_SUPPLEMENT

Colon delivered vitamin C (ascorbic acid) for 12 weeks

Also known as: Ascorbic acid

High dose; Low dose; Mid dose

placebo OTHER

Colon delivered placebo once a day for 12 weeks

Also known as: Microcrystalline cellulose

Placebo

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be willing and able to give written informed consent and to understand, to participate, and to comply with the clinical study requirements.
• Between 50 and 70 years of age.
• Has a BMI of between 18.5 - 30 Kg/m2.
• Participants have had a stable body weight (≤5 % change) over the past 3-months.
• Is in general good health, as determined by interview and vital signs (blood pressure, heart rate, pulse) by the investigator.
• Willing to avoid consuming gut microbiome modulating dietary supplements, prebiotic, probiotic, or fibre-rich supplements, and, within 4 weeks prior to the baseline visit, until the end of the study.
• Maintain current level of physical activity.
• Willing to consume the investigational product daily for the duration of the study.
• Female participants in menopause for at least the last one year.

You may not qualify if:

• Are hypersensitive to any of the components of the test product.
• Has taken antibiotics within the previous 3 months prior to Baseline (Visit 2).
• Is currently using systemic steroids, systemic antibiotics, proton pump inhibitors, H2 blocker, antacid, metformin, or immunosuppressant medication.
• Participant has a history of drug and/or alcohol abuse at the time of enrolment (Drinks more than nationally recommended units per week (\>11 units for women; \>17 units for men); Is currently in treatment for alcohol/substance abuse; Has been diagnosed with alcohol/substance abuse disorder).
• Is a smoker or vaper.
• Vegetarian or vegan.
• Has made any major dietary changes in the past 3 months prior to Baseline (Visit 2).
• Planned major changes in the lifestyle (i.e., diet, dieting, exercise level, significant travel) during the duration of the study.
• Has a currently active eating disorder.
• Has food allergies or other issues with foods that would preclude the intake of the study products, as determined by the study investigator.
• Is having a typical fibre intake \>30 g fibre/day.
• Has an active gastrointestinal disorder or previous gastrointestinal surgery, which in the opinion of the investigator would impact the study outcomes.
• If taking chronic medications (e.g., anti-hypertensive medications), they must have been taking the product for at least two months to screening and agree to maintain the same dosage throughout the study.
• Has severe or uncontrolled type 2 diabetes, psychiatric disorder, gastrointestinal disease (i.e., diarrhoea, Crohn's disease, ulcerative colitis, IBS, diverticulosis, stomach or duodenal ulcers respiratory or cardiac illness or any other condition which in the opinion of the investigator would impact the study outcomes.
• Has a current or history of any gastrointestinal cancer

Sponsors & Collaborators

• DSM Nutritional Products, Inc.: lead
• Atlantia Food Clinical Trials: collaborator

Study Sites (1)

Atlantia Food Clinical Trials, 1st Floor, Block C, Heron House, Blackpool Retail Park, Cork

Cork, Ireland

Location

MeSH Terms

Interventions

Ascorbic Acid; microcrystalline cellulose

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Prof Timothy Dinan

  Cork University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled, parallel trial

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: October 28, 2022
• Study Start: July 1, 2022
• Primary Completion: March 13, 2023
• Study Completion: March 13, 2023
• Last Updated: August 22, 2024

Record last verified: 2024-08

Locations

IE (1)