CognitionNCT06911957
PRECOG Pilot Project
A study testing Prebiotic blend in people with Cognition and Affect (Mental Function), run by University of Reading at 1 site in United Kingdom.
Trial summary
This pilot study aims to investigate the chronic effects of a prebiotic blend on cognitive, affective and gut microbiome outcomes in healthy adults aged 60-75 years. Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognition, Affect (Mental Function), Gut Microbiome
- What is being tested?
- Prebiotic blend
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2025to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aging between 60-75 years old
- Having normal vision and hearing
- Having a normal body mass index (BMI<30)
Who cannot join
- Having mild to moderate subjective cognitive complaints
- Smoking
- Having food allergies
- Following restrictive and/or unbalanced diets
- Changing dietary intake majorly in past month
- Being diagnosed with any psychiatric or neurologic conditions (e.g. schizophrenia, depression, dementia) including eating disorders
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- Being diagnosed with any cardiometabolic diseases (including type II diabetes and cardiovascular disease), or suffering from hypertension or thrombosis related disorders or suffer from thyroid disease
- Currently taking anticoagulants, antiplatelet medication, antidepressants, proton-pump inhibitors
- Currently consuming prebiotic or probiotic supplements
- Continuous antibiotic use for > 3 days within 1 month prior to enrolment
- Continuous use of weight-loss drug for > 1 month before screening
- Having a significant gastrointestinal (GI) condition affecting absorption including (but not limited to) inflammatory bowel disease; total colectomy or bariatric surgery; irritable bowel disease; end stage renal disease; active cancer, or treatment for any cancer, in last 3 years
- Having a high fibre intake defined as > 20g of fibre/day
- Wheat and/or gluten intolerance and having coeliac disease
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Reading, School of Psychology and Clinical Languages
Reading, Berkshire, RG6 6ES
About this study
Official title: The Impact of Chronic Consumption of Plant-based Fibres on Cognitive Performance, Gut Microbiome and Mental Health Outcomes in Older Adults: a Pilot Randomised Controlled Trial
This pilot study aims to investigate the chronic effects of a prebiotic blend on cognitive, affective and gut microbiome outcomes in healthy adults aged 60-75 years.
Read the detailed description
This pilot study will employ a double-blind, randomised, placebo-controlled parallel design to investigate the chronic effects of 12-week-long prebiotic blend consumption on cognitive, affective, gut microbiome, metabolic, and anthropometric outcomes in healthy older adults with mild to moderate subjective cognitive complaints. Fifty participants will be randomised to Intervention or Placebo groups where they will be consuming 10g of prebiotic fibre blend or 10g of placebo (matched placebo powder) per day for 12-weeks. Outcome measures will be acquired before and after a 12-week chronic supplementation. These will include cognitive measures of overall cognitive functioning, and domain-specific cognitive performance, affective measures of depression and anxiety symptomatology; gastrointestinal symptomatology; systolic and diastolic blood pressure, as well as height, weight, hip and waist circumference. In addition, stool samples will be collected at all timepoints to assess microbiome diversity and composition.
- Conditions
- Cognition, Affect (Mental Function), Gut Microbiome
- Being tested
- Prebiotic blend, Placebo
- Keywords
- prebiotics, cognition, depression, anxiety, gut microbiome diversity, relative abundance
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prebiotic blendDietary supplement
10g of prebiotic fibre blend powder
PlaceboDietary supplement
10g of matched placebo powder
| Study group | Role | What they receive |
|---|---|---|
| Active: prebiotic blend (powder) | Experimental | Subjects will consume 10g of prebiotic fibre powder in their tea/coffee/water at breakfast. Receives: Dietary Supplement: Prebiotic blend |
| Active: matched placebo (powder) | Placebo comparator | Subjects will consume 10g of matched placebo powder in their tea/coffee/water at breakfast. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Drug Research Computerized Assessment System (COGDRAS) scores
The COGDRAS battery consists of 8 individual cognitive tests testing memory, attention and reaction times.
Measured: From baseline (pre intervention) to week 12 (post intervention)
Gut microbiome diversity
Stool samples will be collected to measure gut microbiome diversity. Indices of alpha and beta diversity will be analysed (16s sequencing).
Measured: From baseline (pre intervention) to week 12 (post intervention)
Gut microbiome composition
Stool samples will be collected to measure gut microbiome composition (genus and species) (16s sequencing).
Measured: From baseline (pre intervention) to week 12 (post intervention)
Secondary outcomes (8)
Geriatric Depression Scale scores
A validated self-report measure of depression that includes 15-items.
Measured: From baseline (pre intervention) to week 12 (post intervention)
Geriatric Anxiety Inventory scores
A validated self-report measure of anxiety that includes 20-items.
Measured: From baseline (pre intervention) to week 12 (post intervention)
Montreal Cognitive Assessment (MoCA) score
Composite measure of global cognitive function
Measured: From baseline (pre intervention) to week 12 (post intervention)
Gastrointestinal Symptom Rating Scale Scores
A validated self-report measure of gastrointestinal symptoms that includes 15-items (combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation) .
Measured: From baseline (pre intervention) to week 12 (post intervention)
Blood Pressure
Systolic and diastolic blood pressure (in mmHg) will be measured.
Measured: From baseline (pre intervention) to week 12 (post intervention)
Positive and Negative Affect Schedule (PANAS)
A 20-item questionnaire measuring positive and negative affect.
Measured: From baseline (pre intervention) to week 12 (post intervention)
Hip and waist circumference
Hip and waist circumference (in cm) will be measured.
Measured: From baseline (pre intervention) to week 12 (post intervention)
Body Mass Index
Weight (in kg) and height (in m) will be combined to report BMI in kg/m^2.
Measured: From baseline (pre intervention) to week 12 (post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start1 May 2025
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CognitionStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Collaborators
- Biotechnology and Biological Sciences Research Council, Myota Limited, i-NutriLife Hub
- Responsible party
- Principal investigator, Piril Hepsomali, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06911957
- Sponsor's protocol ID
- UREC 25/03
- Status last verified
- Dec 2025
- First submitted
- 20 Mar 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Chronic Consumption of Plant-based Fibres on Cognitive Performance, Gut Microbiome and Mental Health Outcomes in Older Adults: a Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06911957
- Acronym / sponsor ID
- UREC 25/03
- Conditions
- Cognition, Affect (Mental Function), Gut Microbiome
- Keywords
- prebiotics, cognition, depression, anxiety, gut microbiome diversity, relative abundance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Collaborators
- Biotechnology and Biological Sciences Research Council, Myota Limited, i-NutriLife Hub
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 4 Apr 2025 (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.
This pilot study aims to investigate the chronic effects of a prebiotic blend on cognitive, affective and gut microbiome outcomes in healthy adults aged 60-75 years.
Detailed description
This pilot study will employ a double-blind, randomised, placebo-controlled parallel design to investigate the chronic effects of 12-week-long prebiotic blend consumption on cognitive, affective, gut microbiome, metabolic, and anthropometric outcomes in healthy older adults with mild to moderate subjective cognitive complaints. Fifty participants will be randomised to Intervention or Placebo groups where they will be consuming 10g of prebiotic fibre blend or 10g of placebo (matched placebo powder) per day for 12-weeks. Outcome measures will be acquired before and after a 12-week chronic supplementation. These will include cognitive measures of overall cognitive functioning, and domain-specific cognitive performance, affective measures of depression and anxiety symptomatology; gastrointestinal symptomatology; systolic and diastolic blood pressure, as well as height, weight, hip and waist circumference. In addition, stool samples will be collected at all timepoints to assess microbiome diversity and composition.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active: prebiotic blend (powder) | Experimental | Dietary Supplement: Prebiotic blendSubjects will consume 10g of prebiotic fibre powder in their tea/coffee/water at breakfast. |
| Active: matched placebo (powder) | Placebo comparator | Dietary Supplement: PlaceboSubjects will consume 10g of matched placebo powder in their tea/coffee/water at breakfast. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aging between 60-75 years old
- Having normal vision and hearing
- Having a normal body mass index (BMI<30)
Key exclusion criteria (14 listed)
- Having mild to moderate subjective cognitive complaints
- Smoking
- Having food allergies
- Following restrictive and/or unbalanced diets
- Changing dietary intake majorly in past month
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 |
|---|---|---|
| Prebiotic blend10g of prebiotic fibre blend powder | Dietary supplement | Active: prebiotic blend (powder) |
| Placebo10g of matched placebo powder | Dietary supplement | Active: matched placebo (powder) |
Primary outcome
Cognitive Drug Research Computerized Assessment System (COGDRAS) scores
Time frame: From baseline (pre intervention) to week 12 (post intervention)
The COGDRAS battery consists of 8 individual cognitive tests testing memory, attention and reaction times.
Gut microbiome diversity
Time frame: From baseline (pre intervention) to week 12 (post intervention)
Stool samples will be collected to measure gut microbiome diversity. Indices of alpha and beta diversity will be analysed (16s sequencing).
Gut microbiome composition
Time frame: From baseline (pre intervention) to week 12 (post intervention)
Stool samples will be collected to measure gut microbiome composition (genus and species) (16s sequencing).
8 secondary outcomes
Geriatric Depression Scale scores
Time frame: From baseline (pre intervention) to week 12 (post intervention)
Geriatric Anxiety Inventory scores
Time frame: From baseline (pre intervention) to week 12 (post intervention)
Montreal Cognitive Assessment (MoCA) score
Time frame: From baseline (pre intervention) to week 12 (post intervention)
Gastrointestinal Symptom Rating Scale Scores
Time frame: From baseline (pre intervention) to week 12 (post intervention)
Blood Pressure
Time frame: From baseline (pre intervention) to week 12 (post intervention)
Positive and Negative Affect Schedule (PANAS)
Time frame: From baseline (pre intervention) to week 12 (post intervention)
Hip and waist circumference
Time frame: From baseline (pre intervention) to week 12 (post intervention)
Body Mass Index
Time frame: From baseline (pre intervention) to week 12 (post intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prebiotic blend in people with Cognition and Affect (Mental Function), run by University of Reading 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 14 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: finished, as of the sponsor's last update on 3 Dec 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Drug Research Computerized Assessment System (COGDRAS) scores (time frame: From baseline (pre intervention) to week 12 (post intervention)). The study lists 3 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 3 Dec 2025.