At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Inulin and B-vitamins (supplement), Inulin (supplement), Placebo (supplement)
- How long the study runs
- Study runs about 7 months (dates as stated)
- About the drug or intervention
- Inulin and B-vitamins — 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 — supplement: A functional drink containing inulin (7.5 g per serving) without additional B-vitamins. · Placebo — supplement: A control/placebo drink with similar energy content (\~182 kJ / 43 kcal/ per serving) but without the additional nutrient provision.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 50 Years and over
- Who
- All
- Number of participants
- 84
- Started
- 2026-05-18
- Last checked
- 2026-05
Plain English Summary
What is this study?
- • Testing a new treatment for biomarkers of b-vitamin status and gut microbiome composition
- • NA - 84 participants
- • Ageing is associated with changes in gut microbiota composition, increased inflammation, and a greater risk of poor mental health outcomes
Who can take part?
- • Ages 50 Years and over
- • Diagnosed with biomarkers of b-vitamin status and gut microbiome composition
Where?
- • Coleraine - Human Intervention Studies Unit
This is a simplified summary. Always discuss with your doctor before making any decisions.
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 50 Years and over
- Who can join: All genders
What the study is looking for
- ✓Community-dwelling
- ✓Non or low consumers (≤ 4 portions/week) of foods/beverages fortified with B-vitamins
- ✓Individuals with the capacity to provide agreement to take part
Who cannot take part
- ✗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)
See the full criteria
Where Is This Study? (1 UK site)
Human Intervention Studies Unit
Coleraine BT521SA, United Kingdom
How to Get in Touch
Shane Gordon, PhD
Sponsor contactCONTACT