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)

NCT07592975 | Recruiting

• 1 other identifier: REC/24/0064
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Biomarkers of B-vitamin Status and Gut Microbiome Composition

Keywords

Functional food; Healthy ageing; B-vitamin status; Gut microbes; Inulin

Outcome Measures

Primary Outcomes (6)

• Gut microbiome profile

  Faecal samples will be collected to examine the gut microbiome profile using faecal 16S rRNA profiling, V3-V4 region and QIIME2 pipeline.

  12 weeks

• Serum total homocysteine

  Measured by gas chromatography-tandem mass spectrometry based on methylchloroformate derivatisation.

  12 weeks

• Folate

  Serum folate and red blood cell folate measured by microbiological assay based on a chloramphenicol-resistant strain of Lactobacillus casei.

  12 weeks

• Vitamin B12

  Serum total vitamin B12 measured by microbiological assay based on a colistin sulphate-resistant strain of Lactobacillus leichmannii; serum methylmalonic acid measured by gas chromatography-tandem mass spectrometry based on methylchloroformate derivatisation.

  12 weeks

• Vitamin B6

  Vitamin B6 status as measured by plasma pyridoxal-5-phosphate using high-performance liquid chromatography with fluorescence detection.

  12 weeks

• Riboflavin

  Measured using the functional assay erythrocyte glutathione reductase activation coefficient, EGRac

  12 weeks

Secondary Outcomes (6)

• Inflammation

  12 weeks

• Gut microbial metabolites

  12 weeks

• Depressive symptoms

  12 weeks

• Anxiety symptoms

  12 weeks

• Sleep quality

  12 weeks

Study Arms (3)

Inulin and B-vitamins

ACTIVE COMPARATOR

Dietary Supplement: Inulin and B-vitamins

Inulin only

ACTIVE COMPARATOR

Dietary Supplement: Inulin

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Inulin and B-vitamins DIETARY_SUPPLEMENT

A functional beverage containing inulin (7.5 g per serving) combined with B-vitamins folic acid (100μg), vitamin B12 (5μg), vitamin B6 (5mg) and riboflavin (2.5mg).

Inulin and B-vitamins

Inulin DIETARY_SUPPLEMENT

A functional drink containing inulin (7.5 g per serving) without additional B-vitamins.

Inulin only

Placebo DIETARY_SUPPLEMENT

A control/placebo drink with similar energy content (\~182 kJ / 43 kcal/ per serving) but without the additional nutrient provision.

Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• University of Ulster: lead
• ABC Nutritionals: collaborator
• Sensus B.V. (Royal Cosun), Roosendaal, The Netherlands: collaborator
• University of Leeds: collaborator

Study Sites (1)

Human Intervention Studies Unit

Coleraine, County Londonderry, BT521SA, United Kingdom

RECRUITING

MeSH Terms

Interventions

Inulin; Folic Acid

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Fructans; Polysaccharides; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Shane Gordon, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: Twice daily intervention for 12 weeks with one of the following treatments (in powder form): 1. A functional drink containing chicory inulin (7.5 g per serving) combined with B-vitamins: folic acid (100μg), vitamin B12 (5μg), vitamin B6 (5mg) and riboflavin (2.5mg). 2. A functional drink containing chicory inulin (7.5 g per serving) without additional B-vitamins. 3. A control/placebo drink with similar energy content (\~182 kJ / 43 kcal/ per serving) but without the additional nutrient provision.

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 18, 2026
• Study Start: May 18, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)