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)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorUniversity of Ulster

About this trial

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.

Eligibility criteria

Qualifiers

Community-dwelling

Non or low consumers (≤ 4 portions/week) of foods/beverages fortified with B-vitamins

Individuals with the capacity to provide informed consent

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Inulin and B-vitamins
  • Inulin
  • Placebo

Treatment groups

84 Participants
are divided into 3 treatment groups

Sponsors and collaborators

University of Ulster

Lead sponsor

ABC Nutritionals

Collaborator

Sensus B.V. (Royal Cosun), Roosendaal, The Netherlands

Collaborator

University of Leeds

Collaborator