Effect of a prebiotic drink with or without B-vitamins on gut microbes and wellbeing in older adults
Official title: 'GutFood' - Effect of a Food Intervention With a Prebiotic Alone or Combined With B-vitamins on Gut Microbiota Diversity, Inflammation and Mental Health Outcomes in Older Adults
Run by University of Ulster · NCT07592975 · Data updated 2026-11-12
A 12-week, randomized, double-blind study tests whether a chicory inulin drink, alone or with B-vitamins, can improve gut microbiota diversity, inflammation, and mental health in older adults who don’t get much B-vitamin–fortified food.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 50 Years and up |
| Sex | All |
| Enrollment | 84 (estimated) |
| Sponsor | University of Ulster Academic / other |
| Locations | 1 site (Coleraine, County Londonderry) |
| Status | Recruiting |
| Started | May 18, 2026 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | May 18, 2026 |
| Trial ID | NCT07592975 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Community-dwelling adults aged 65 and older who are low in B-vitamin–fortified foods and not taking related supplements.
✕Probably not a fit
Individuals already consuming adequate B-vitamins or prebiotics, or those with conditions/exclusions such as GI disease or recent antibiotic use, may not see benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study investigates how a functional drink enriched with chicory inulin, with or without B-vitamins, affects gut microbiome diversity, nutritional status, inflammation, and mental health in adults aged older than 65. Participants are randomized to receive inulin alone, inulin plus B-vitamins, or a placebo, in a double-blind design over 12 weeks. Primary outcomes focus on changes in gut microbiota composition and inflammatory markers, with secondary assessments of nutrient status and mood or cognitive-related measures. The trial is conducted in the Netherlands with collaboration among universities and industry partners, and targets community-dwelling individuals who consume little fortified foods. Eligibility excludes those on B-vitamin injections or other relevant supplements, recent antibiotic use, GI disease, or serious chronic illness.
Why it matters
Potential benefit: If successful, the drink could support healthier gut microbes, lower inflammation, and better mental health signs in older adults.
How similar studies have gone: Previous work suggests prebiotics can modulate gut microbiota and inflammation, but combining prebiotics with B-vitamins for mental health outcomes is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Community-dwelling * Non or low consumers (≤ 4 portions/week) of foods/beverages fortified with B-vitamins * Individuals with the capacity to provide informed consent Exclusion Criteria: * B12 injection users * Using supplements containing the nutrients of interest (B-vitamins, inulin, probiotics) * Taking medications that interfere with B-vitamin metabolism * Currently taking antibiotics * GI disease (Crohn's, coeliac) * Serious chronic disease (e.g. cancer, liver disease)
Where it's running
-
Human Intervention Studies Unit
Coleraine, County Londonderry, United Kingdom Recruiting
Study contacts
- Study coordinator: Shane Gordon, PhD
- Email: S.Gordon2@ulster.ac.uk
- Phone: +44 28 7012 3035
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.