RecruitingNot Applicable

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 (GutFood)

United Kingdom84 participantsStarted 2026-05-18

Plain-language summary

Ageing is associated with changes in gut microbiota composition, increased inflammation, and a greater risk of poor mental health outcomes. Nutritional inadequacies, including low dietary fibre intake and suboptimal B-vitamin status, are common in older adults and may contribute to these age-related health issues. Research suggests that increasing dietary fibre intake, particularly through prebiotics such as inulin, may help to improve gut health. In addition, B-vitamins have been linked to both gut and mental health, although their combined effects with prebiotics are not well understood. With the assistance of a food company, the investigators have developed a functional drink enriched with chicory inulin, alone or in combination with B-vitamins. Therefore, the investigators plan to conduct a 12-week randomised, double-blind, placebo-controlled trial to test the effect of this functional drink on gut health outcomes, nutritional status, inflammation, and mental health in adults aged 50 years and older.

Who can participate

Age range

50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Gut microbiome profile

Timeframe: 12 weeks

Serum total homocysteine

Timeframe: 12 weeks

Folate

Timeframe: 12 weeks

Vitamin B12

Timeframe: 12 weeks

Vitamin B6

Timeframe: 12 weeks

Riboflavin

Timeframe: 12 weeks

Trial details

NCT IDNCT07592975

SponsorUniversity of Ulster

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Shane Gordon, PhD

+44 28 7012 3035 S.Gordon2@ulster.ac.uk

View on ClinicalTrials.gov More Biomarkers of B-vitamin Status and Gut Microbiome Composition trials

Plain-language summary

Who can participate

Age range

50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.