Biomarkers of B-vitamin Status and Gut Microbiome CompositionNCT07592975
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)
A study testing Inulin and B-vitamins and Inulin in people with Biomarkers of B-vitamin Status and Gut Microbiome Composition, run by University of Ulster at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Biomarkers of B-vitamin Status and Gut Microbiome Composition
- What is being tested?
- Inulin and B-vitamins and Inulin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 May 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Community-dwelling
- Non or low consumers (≤ 4 portions/week) of foods/beverages fortified with B-vitamins
- Individuals with the capacity to provide informed consent
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Human Intervention Studies Unit
Coleraine, County Londonderry, BT521SA
Julie Sittlington, PhD, +44 28 7012 4101, jj.sittlington@ulster.ac.uk
About this study
Official 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
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.
- Being tested
- Inulin and B-vitamins, Inulin, Placebo
- Keywords
- Functional food, Healthy ageing, B-vitamin status, Gut microbes, Inulin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inulin and B-vitaminsDietary 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).
InulinDietary supplement
A functional drink containing inulin (7.5 g per serving) without additional B-vitamins.
PlaceboDietary supplement
A control/placebo drink with similar energy content (~182 kJ / 43 kcal/ per serving) but without the additional nutrient provision.
| Study group | Role | What they receive |
|---|---|---|
| Inulin and B-vitamins | Active comparator | Not described Receives: Dietary Supplement: Inulin and B-vitamins |
| Inulin only | Active comparator | Not described Receives: Dietary Supplement: Inulin |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbiome profile
Faecal samples will be collected to examine the gut microbiome profile using faecal 16S rRNA profiling, V3-V4 region and QIIME2 pipeline.
Measured: 12 weeks
Serum total homocysteine
Measured by gas chromatography-tandem mass spectrometry based on methylchloroformate derivatisation.
Measured: 12 weeks
Folate
Serum folate and red blood cell folate measured by microbiological assay based on a chloramphenicol-resistant strain of Lactobacillus casei.
Measured: 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.
Measured: 12 weeks
Vitamin B6
Vitamin B6 status as measured by plasma pyridoxal-5-phosphate using high-performance liquid chromatography with fluorescence detection.
Measured: 12 weeks
Riboflavin
Measured using the functional assay erythrocyte glutathione reductase activation coefficient, EGRac
Measured: 12 weeks
Secondary outcomes (6)
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).
Measured: 12 weeks
Gut microbial metabolites
Faecal short-chain fatty acids (SCFAs)
Measured: 12 weeks
Depressive symptoms
Measured using the Centre for Epidemiological Studies Depression Scale (CES-D).
Measured: 12 weeks
Anxiety symptoms
Measured using the Hospital Anxiety and Depression Scale (HADS).
Measured: 12 weeks
Sleep quality
Measured using the Pittsburgh Sleep Quality Index (PSQI).
Measured: 12 weeks
Physiological stress
Serum cortisol concentrations measured as a biomarker of physiological stress.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start18 May 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biomarkers of B-vitamin Status and Gut Microbiome CompositionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Collaborators
- ABC Nutritionals, Sensus B.V. (Royal Cosun), Roosendaal, The Netherlands, University of Leeds
- Responsible party
- Principal investigator, Leane Hoey, University of Ulster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07592975
- Sponsor's protocol ID
- REC/24/0064
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07592975
- Acronym / sponsor ID
- REC/24/0064
- Keywords
- Functional food, Healthy ageing, B-vitamin status, Gut microbes, Inulin
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Collaborators
- ABC Nutritionals, Sensus B.V. (Royal Cosun), Roosendaal, The Netherlands, University of Leeds
- Study start
- 18 May 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Inulin and B-vitamins | Active comparator | Dietary Supplement: Inulin and B-vitamins |
| Inulin only | Active comparator | Dietary Supplement: Inulin |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Community-dwelling
- Non or low consumers (≤ 4 portions/week) of foods/beverages fortified with B-vitamins
- Individuals with the capacity to provide informed consent
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inulin and B-vitaminsA 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 supplement | Inulin and B-vitamins |
| InulinA functional drink containing inulin (7.5 g per serving) without additional B-vitamins. | Dietary supplement | Inulin only |
| PlaceboA control/placebo drink with similar energy content (~182 kJ / 43 kcal/ per serving) but without the additional nutrient provision. | Dietary supplement | Placebo |
Primary outcome
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.
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
6 secondary outcomes
Inflammation
Time frame: 12 weeks
Gut microbial metabolites
Time frame: 12 weeks
Depressive symptoms
Time frame: 12 weeks
Anxiety symptoms
Time frame: 12 weeks
Sleep quality
Time frame: 12 weeks
Physiological stress
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inulin and B-vitamins and Inulin in people with Biomarkers of B-vitamin Status and Gut Microbiome Composition, run by University of Ulster at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shane Gordon, PhD (+44 28 7012 3035, S.Gordon2@ulster.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut microbiome profile (time frame: 12 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.