Study on Effects of a Functional Drink with Prebiotic Inulin and B-vitamins on Gut Health, Inflammation, and Mental Well-being in Adults 50 and Older

What this Trial Is About

Researchers are investigating how a functional drink containing prebiotics and B-vitamins affects gut health, inflammation, and mental health in adults aged 50 years and older. Ageing can change gut bacteria and increase inflammation, which may worsen mental health. The study aims to test if increasing dietary fiber through inulin and adding B-vitamins can improve gut microbiota diversity and nutritional status in this population. The trial is a 12-week randomized, double-blind, placebo-controlled study comparing three groups one receiving a drink with inulin plus B-vitamins, another with inulin only, and a placebo group. Each serving of the active drinks contains 7.5 grams of inulin, with the combination drink also providing folic acid, vitamin B12, vitamin B6, and riboflavin. The placebo drink has similar calories but no added nutrients. Participants will be monitored through gut microbiome profiles and blood tests measuring total homocysteine, folate, vitamin B12, B6, and riboflavin at 12 weeks. Secondary assessments include inflammation markers, gut microbial metabolites, mood symptoms, sleep quality, and physiological stress. The study sponsors aim to evaluate these effects without requiring long-term treatment, and participation lasts for the full 12 weeks.

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)