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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Inulin and B-vitamins
Dietary supplementA 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 supplementA functional drink containing inulin (7.5 g per serving) without additional B-vitamins.
Placebo
Dietary supplementA control/placebo drink with similar energy content (\~182 kJ / 43 kcal/ per serving) but without the additional nutrient provision.
Treatment groups
Trial outcomes
Primary outcomes
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.
Serum total homocysteine
Measured by gas chromatography-tandem mass spectrometry based on methylchloroformate derivatisation.
Folate
Serum folate and red blood cell folate measured by microbiological assay based on a chloramphenicol-resistant strain of Lactobacillus casei.
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.
Secondary outcomes
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).
Gut microbial metabolites
Faecal short-chain fatty acids (SCFAs)
Depressive symptoms
Measured using the Centre for Epidemiological Studies Depression Scale (CES-D).
Anxiety symptoms
Measured using the Hospital Anxiety and Depression Scale (HADS).
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