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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)

RecruitingNAAges 50 Years - anyAllUniversity of Ulster
NCT07592975 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 functio

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📋 Eligibility rules (as published)
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)
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What it tests

  • Inulin and B-vitamins
  • Inulin
  • Placebo
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Where

1 site
Human Intervention Studies Unit
Coleraine, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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