Biomarkers of B-vitamin Status and Gut Microbiome Composition
Conditions
Keywords
Functional food, Healthy ageing, B-vitamin status, Gut microbes, Inulin
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.
Interventions
DIETARY_SUPPLEMENTInulin and B-vitamins
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).
DIETARY_SUPPLEMENTInulin
A functional drink containing inulin (7.5 g per serving) without additional B-vitamins.
DIETARY_SUPPLEMENTPlacebo
A control/placebo drink with similar energy content (\~182 kJ / 43 kcal/ per serving) but without the additional nutrient provision.
Sponsors
University of Ulster
ABC Nutritionals
Sensus B.V. (Royal Cosun), Roosendaal, The Netherlands
University of Leeds
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gut microbiome profile | 12 weeks | 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 | 12 weeks | Measured by gas chromatography-tandem mass spectrometry based on methylchloroformate derivatisation. |
| Folate | 12 weeks | Serum folate and red blood cell folate measured by microbiological assay based on a chloramphenicol-resistant strain of Lactobacillus casei. |
| Vitamin B12 | 12 weeks | 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. |
| Vitamin B6 | 12 weeks | Vitamin B6 status as measured by plasma pyridoxal-5-phosphate using high-performance liquid chromatography with fluorescence detection. |
| Riboflavin | 12 weeks | Measured using the functional assay erythrocyte glutathione reductase activation coefficient, EGRac |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inflammation | 12 weeks | 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 | 12 weeks | Faecal short-chain fatty acids (SCFAs) |
| Depressive symptoms | 12 weeks | Measured using the Centre for Epidemiological Studies Depression Scale (CES-D). |
| Anxiety symptoms | 12 weeks | Measured using the Hospital Anxiety and Depression Scale (HADS). |
| Sleep quality | 12 weeks | Measured using the Pittsburgh Sleep Quality Index (PSQI). |
| Physiological stress | 12 weeks | Serum cortisol concentrations measured as a biomarker of physiological stress. |
Countries
United Kingdom
Contacts
CONTACTShane Gordon, PhD
Outcome results
None listed