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Clinical Trials/NCT07592975
NCT07592975RecruitingNot Applicable

'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

University of Ulster1 site in 1 country84 target enrollmentStarted: May 18, 2026Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
84
Locations
1

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
50 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Leane Hoey

Dr

University of Ulster

Study Sites (1)

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