Clinical trial NCT05803811: Effect of Colon Delivered Vitamin B2 on Gut Microbiota and Related Health Biomarkers in Healthy Older Adults
Official title: Effect of Colon Delivered Vitamin B2 on Gut Microbiota and Related Health Biomarkers in Healthy Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Keywords: microbiota
vitaminB2
Riboflavin
ShortChain fatty acids
Lead sponsor: DSM Nutritional Products, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Atlantia Food Clinical Trials
First posted: 2023-04-07
Enrollment: 348
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, placebo-controlled, parallel trial
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this intervention study (clinical trial) is to investigate the effect of colon-delivered Riboflavin (vitamin B2) on the faecal microbial composition and diversity in older healthy subjects (50 -70 years of age)


Eligibility criteria: Inclusion Criteria:

1. Participants must be willing and able to give written informed consent and to understand, to participate, and to comply with the clinical study requirements.
2. Between 50 and 70 years of age.
3. Has a BMI of between 18.5 - 30 Kg/m2.
4. Participants have had a stable body weight (≤5 % change) over the past 3-months.
5. Is in general good health, as determined by interview and vital signs (blood pressure, heart rate, pulse) by the investigator.
6. 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.
7. Maintain current level of physical activity.
8. Willing to consume the investigational product daily for the duration of the study.
9. Female participants in menopause for at least the last one year. -

Exclusion Criteria:

1. Are hypersensitive to any of the components of the test product.
2. Has taken antibiotics within the previous 3 months prior to Baseline (Visit2)
3. Is currently using systemic steroids, systemic antibiotics, proton pump inhibitors, H2 blocker, antacid, metformin, or immunosuppressant medication.
4. 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).
5. Is a smoker or vaper.
6. Vegetarian or vegan.
7. Has made any major dietary changes in the past 3 months prior to Baseline (Visit 2).
8. Planned major changes in the lifestyle (i.e., diet, dieting, exercise level, significant travel) during the duration of the study.
9. Has a currently active eating disorder.
10. Has food allergies or other issues with foods that would preclude the intake of the study products, as determined by the study investigator.
11. Is having a typical fibre intake \>30 g fibre/day.
12. Has an active gastrointestinal disorder or previous gastrointestinal surgery, which in the opinion of the investigator would impact the study outcomes.
13. 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.
14. 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.
15. Has a current or history of any gastrointestinal cancer
16. Are severely immunocompromised (HIV positive, transplant patient, on anti-rejection medications, on a steroid for \>30 days, or chemotherapy or radiotherapy with the last year).
17. Experiences alarm features such as weight loss, rectal bleeding, a recent change in bowel habit (\<3 months).
18. Have a current malignant disease or any concomitant end-stage organ disease.
19. Individuals who, in the opinion of the investigator are considered to be poor attendees or unlikely for any reason to be able to comply with the trial.
20. Participants may not be receiving treatment involving experimental drugs. If the participant has been in a recent experimental trial, these must have been completed not less than 60 days prior to this study.
21. Participants who have undergone intensive skin treatments (e.g. laser treatment or skin related surgery) in the last 3 months.
22. If taking any dietary supplements or medications known to affect skin health or other trial measures (resveratrol, ginkgo biloba, ginseng, fruit powder extracts and DHA).
23. Has a skin condition likely to interfere with skin assessments (e.g., eczema, dermatitis, any open skin wounds, reactive and sensitive skin).

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Primary outcomes:
measure: Faecal microbial composition and diversity
timeFrame: from baseline to 12 weeks
Secondary outcomes:
measure: Faecal microbial metabolites fatty acid content at baseline and week 12
timeFrame: Intestinal inflammation as assessed by faecal calprotectin at baseline and at week 12
measure: Intestinal inflammation
timeFrame: from baseline to 12 weeks
measure: Intestinal barrier integrity
timeFrame: from baseline to 12 weeks
measure: Oxidative stress in blood
timeFrame: from baseline to 12 weeks
measure: Inflammatory status in blood
timeFrame: from baseline to 12 weeks
measure: Gastrointestinal symptoms
timeFrame: from baseline to 12 weeks
measure: health-related quality of life
timeFrame: from baseline to 12 weeks
measure: Stool consistency
timeFrame: from baseline to 12 weeks
measure: Stool frequency
timeFrame: from baseline to 12 weeks
measure: Systemic vitamin status
timeFrame: from baseline to 12 weeks
measure: Faecal physiological pH
timeFrame: from baseline to 12 weeks
measure: Faecal microbial composition and diversity at week 4
timeFrame: from baseline to 4 weeks
measure: Microbial metabolites at week 4
timeFrame: from baseline to 4 weeks
Other outcomes:
measure: Skin barrier integrity
timeFrame: from baseline to 12 weeks
measure: Skin hydration
timeFrame: from baseline to 12 weeks
measure: Objective skin-health
timeFrame: from baseline to 12 weeks
Locations:
city: Cork
country: Ireland
facility: Atlantia Food Clinical Trials, 1st Floor, Block C, Heron House, Blackpool Retail Park, Cork
Study officials:
affiliation: Cork University Hospital
name: Prof Timothy Dinan
role: PRINCIPAL_INVESTIGATOR
References: