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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
84
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).
A functional drink containing inulin (7.5 g per serving) without additional B-vitamins.
A control/placebo drink with similar energy content (\~182 kJ / 43 kcal/ per serving) but without the additional nutrient provision.
Human Intervention Studies Unit
Coleraine, County Londonderry, United Kingdom
RECRUITINGGut 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
Serum total homocysteine
Measured by gas chromatography-tandem mass spectrometry based on methylchloroformate derivatisation.
Time frame: 12 weeks
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
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
Vitamin B6
Vitamin B6 status as measured by plasma pyridoxal-5-phosphate using high-performance liquid chromatography with fluorescence detection.
Time frame: 12 weeks
Riboflavin
Measured using the functional assay erythrocyte glutathione reductase activation coefficient, EGRac
Time frame: 12 weeks
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
Gut microbial metabolites
Faecal short-chain fatty acids (SCFAs)
Time frame: 12 weeks
Depressive symptoms
Measured using the Centre for Epidemiological Studies Depression Scale (CES-D).
Time frame: 12 weeks
Anxiety symptoms
Measured using the Hospital Anxiety and Depression Scale (HADS).
Time frame: 12 weeks
Sleep quality
Measured using the Pittsburgh Sleep Quality Index (PSQI).
Time frame: 12 weeks
Physiological stress
Serum cortisol concentrations measured as a biomarker of physiological stress.
Time frame: 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.