Human Intervention Studies Unit
Coleraine, County Londonderry, BT521SA, United Kingdom
Location status: Recruiting
Recruiting
NCT Number: NCT07592975
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)
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.
Recruiting
Interested in participating?
Request InfoKey information
Age range
50 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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)
Treatment and study plan
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.
Primary outcomes
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Gut microbiome profile
Time frame: 12 weeks
Faecal samples will be collected to examine the gut microbiome profile using faecal 16S rRNA profiling, V3-V4 region and QIIME2 pipeline.
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Serum total homocysteine
Time frame: 12 weeks
Measured by gas chromatography-tandem mass spectrometry based on methylchloroformate derivatisation.
-
Folate
Time frame: 12 weeks
Serum folate and red blood cell folate measured by microbiological assay based on a chloramphenicol-resistant strain of Lactobacillus casei.
-
Vitamin B12
Time frame: 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
Time frame: 12 weeks
Vitamin B6 status as measured by plasma pyridoxal-5-phosphate using high-performance liquid chromatography with fluorescence detection.
-
Riboflavin
Time frame: 12 weeks
Measured using the functional assay erythrocyte glutathione reductase activation coefficient, EGRac
Secondary outcomes
-
Inflammation
Time frame: 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
Time frame: 12 weeks
Faecal short-chain fatty acids (SCFAs)
-
Depressive symptoms
Time frame: 12 weeks
Measured using the Centre for Epidemiological Studies Depression Scale (CES-D).
-
Anxiety symptoms
Time frame: 12 weeks
Measured using the Hospital Anxiety and Depression Scale (HADS).
-
Sleep quality
Time frame: 12 weeks
Measured using the Pittsburgh Sleep Quality Index (PSQI).
-
Physiological stress
Time frame: 12 weeks
Serum cortisol concentrations measured as a biomarker of physiological stress.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
University of Ulster
Other
Collaborators
- ABC Nutritionals
- Sensus B.V. (Royal Cosun), Roosendaal, The Netherlands
- University of Leeds
Registry information
Official study title
'GutFood' - 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
Important dates
- Study start
- 2026
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- May 18, 2026
- Registry last updated
- May 18, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.