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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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

    Dietary supplement

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

  • Placebo

    Dietary supplement

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

Treatment groups

84 Participants
are divided into 3 treatment groups
Group A: Inulin and B-vitaminsActive comparator 1 intervention
Group B: Inulin onlyActive comparator 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
12 weeks
2

Serum total homocysteine

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

Time frame
12 weeks
3

Folate

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

Time frame
12 weeks
4

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.

Time frame
12 weeks

Secondary outcomes

1

Inflammation

Markers of inflammation (analysed by enzyme-linked immunosorbent assay): C-reactive protein (CRP), interleukin 6 (IL-6), interleukin 10 (IL-10), tumour necrosis factor (TNF-α).

Time frame
12 weeks
2

Gut microbial metabolites

Faecal short-chain fatty acids (SCFAs)

Time frame
12 weeks
3

Depressive symptoms

Measured using the Centre for Epidemiological Studies Depression Scale (CES-D).

Time frame
12 weeks
4

Anxiety symptoms

Measured using the Hospital Anxiety and Depression Scale (HADS).

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Ulster

Lead sponsor

ABC Nutritionals

Collaborator

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

Collaborator

University of Leeds

Collaborator