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)
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Biomarkers of B-vitamin Status and Gut Microbiome Composition
In brief
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.
Key facts
- Study ID
- NCT07592975
- Run by
- University of Ulster
- People needed
- 84
- Starts
- 2026-05-18
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-05-18
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Community-dwelling
- Non or low consumers (≤ 4 portions/week) of foods/beverages fortified with B-vitamins
- Individuals with the capacity to provide informed consent
You may not qualify if…
- 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 is running
- Human Intervention Studies Unit — Coleraine, County Londonderry, United Kingdom (enrolling)
Full record on ClinicalTrials.gov
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