Cognitive DeclineMAEVENCT07226674
Microbiota Mediated Flavonoid Metabolites for Cognitive Health
A study testing Polyphenol Supplement in people with Cognitive Decline and Cognitive Dysfunction, run by University of Ulster at 1 site in United Kingdom.
Trial summary
Globally, populations are ageing increasing the prevalence of Alzheimer's disease (AD), due to lack of effective treatments. The traditional Mediterranean diet, rich in fibre and polyphenols (PPs) can help prevent or delay cognitive dysfunction and preserve healthy brain structure and function. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Decline, Cognitive Dysfunction
- What is being tested?
- Polyphenol Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Nov 2025to Jan 2028
- 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
- 50+ years
- BMI ≥ 25 kg/m2
- Enhanced risk of AD - defined as family history of AD, 1st degree family member
- Habitually consume suboptimal diets such as typical Western diet (i.e., high in animal products, refined carbohydrates and processed food).
- Subjects capable of and willing to comply with the protocol and to give their written informed consent.
Who cannot join
- Cognitive impairment at time of recruitment into the study, as measured by the Mini Mental Status Exam (MMSE, score 25-30), and Clinical Dementia Rating (CDR, score=0) or Everyday Cognition Scale-12 (ECog-12, score<1.36 included).
- Pre-existing psychosis or psychiatric conditions.
- Currently receiving treatment for dementia.
- History of substance abuse or cerebrovascular events.
- Heavy use of tobacco (>1/2 pack per day)
- Any intolerance or allergy documented or suspected to one of the components of the study products.
Show all 18Show fewer
- Have taken probiotics or antibiotic therapy within the last 1 month
- Change in medication use in the last 3 months.
- Frailty, malnutrition, or food allergy/intolerance requiring special diets will also be excluded.
- Following any specific diet (vegetarian, vegan, etc.)
- Body weight at enrolment greater than 400lbs due to weight restrictions on the MRI table.
- Pregnant, breastfeeding, postpartum for less than 6 months, or unwilling to practice birth control during participation in the study.
- Unable to safely participate in the MRI (claustrophobia, presence of devices affected by MRI such as pacemakers, neurostimulators, or metallic foreign body, etc.)
- Chronic pain.
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- Having a psychological or linguistic inability to sign the informed consent;
- Under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision;
- Subject participating in another biomedical study or participation in another study within the 3 months before entry into this study.
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
Ulster University, Human Intervention Studies Unit
Coleraine, BT52 1SA
Aoife Caffrey, PhD, +44 (0) 28 701 23401, a.caffrey@ulster.ac.uk
c.gill@ulster.ac.uk
About this study
Official title: MAEVE: Microbiota Mediated Flavonoid Metabolites for Cognitive Health
Globally, populations are ageing increasing the prevalence of Alzheimer's disease (AD), due to lack of effective treatments. The traditional Mediterranean diet, rich in fibre and polyphenols (PPs) can help prevent or delay cognitive dysfunction and preserve healthy brain structure and function. Cognitive decline is inversely associated with higher PP intakes (>421mg/day) i.e., total flavonoids, flavan-3-ols and flavonoid oligomers. The positive brain effects of flavonoid intake are likely mediated in part by gut microbial PP metabolites, consistent with the emerging role of the brain-gut microbiome (BGM) system in neurodegeneration. Our preliminary data indicate that circulating phenyl-γ-valerolactones (PVL), neuroprotective compounds exclusively produced by gut microbiota from flavan-3-ol rich foods18 are associated with delaying cognitive dysfunction. Intake of PPs change gut microbial composition and function, altering the physiology of the host's secondary bile acid (BA) pool through modulation of bacterial 7α-dehydroxylation of de-conjugated primary BAs into secondary BAs. This is noteworthy as 7α-dehydroxylation of BAs does not happen in the brain and because gut microbial BA metabolites have regulatory and signalling functions in the brain. The ratio between certain primary and secondary BAs is also dysregulated in AD with significantly lower serum concentrations of cholic acid (a primary BA) and increased levels of deoxycholic acid (a bacterially produced secondary BA). The increased ratio of cholic acid to deoxycholic acid is correlated with cognitive decline. Increased levels of tyrosine, tryptophan, purine, and tocopherol have also been identified in postmortem AD brains. However, specific pathways and mechanisms underlying these associations are unclear. In this multi-PI application by leaders in the field of BGM interactions, we leverage the collectively (NIH, HSC, SFI) funded Tripartite US-Ireland R\&D Partnership Program to determine the mechanisms involved in PP intake on maintaining healthier cognitive and brain function, as mediated by gut microbiota metabolites of PP and BAs in 50+ year old elderly with enhanced AD risk.
- Conditions
- Cognitive Decline, Cognitive Dysfunction
- Being tested
- Polyphenol Supplement, Placebo Supplement
- Keywords
- Polyphenols, Mediterranean Diet, Gut Microbiome, Alzheimer Disease
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyphenol SupplementDietary supplement
Juice Plus Essentials, Berry Blend Capsules
Placebo SupplementDietary supplement
Micronutrient matched placebo
| Study group | Role | What they receive |
|---|---|---|
| Polyphenol Supplement | Experimental | Juice Plus Essentials, Berry Blend Capsules Receives: Dietary Supplement: Polyphenol Supplement |
| Placebo Supplement | Placebo comparator | Not described Receives: Dietary Supplement: Placebo Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in Polyphenol-derived metabolite concentrations pre, mid, & post intervention - stool
Measurement of metabolomics via stool specimen.
Measured: Collected three times by the participant at home, once at baseline (week 0), once at mid-study (month 6), and once at the final 12month appointment (month 12)
Differences in Polyphenol-derived metabolite concentrations pre, mid, & post intervention - blood
Measurement of metabolomics via blood specimen.
Measured: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (month 6), and once at the final 12month appointment (month 12).
Differences in microbiome levels pre, mid, & post intervention - Stool
16S RNA sequencing to measure microbiome levels via stool specimen.
Measured: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (month 6), and once at the final 12month appointment (month 12).
Differences in microbiome levels pre & post intervention - Blood
16S RNA sequencing to measure microbiome levels via blood specimen.
Measured: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (month 6), and once at the final 12month appointment (month 12).
Differences in microbiome levels pre, mid, & post intervention - Stool
Shotgun metagenomics, sequencing to measure microbiome levels via stool specimen.
Measured: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (month 6), and once at the final 12month appointment (month 12).
Differences in microbiome levels pre, mid, & post intervention - Blood
Shotgun metagenomics, sequencing to measure microbiome levels via stool specimen.
Measured: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (month 6), and once at the final 12month appointment (month 12).
Differences in Cognitive Measures pre, mid, & post intervention - Executive Function
Administration of a standardized Stroop Neuro-psychological test; participants ability to correctly identify colours when words are printed in conflicting ink colours.
Measured: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (month 6), and once at the final 12month appointment (month 12).
Differences in Cognitive Measures pre, mid, & post intervention - Executive Function
Administration of a standardized Trails A \& B; participants ability to connect dots, in order, as quickly as possible.
Measured: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (month 6), and once at the final 12month appointment (month 12).
Differences in Cognitive Measures pre, mid, & post intervention
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Measured: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (month 6), and once at the final 12month appointment (month 12).
Differences in Cognitive Measures pre, mid, & post intervention
Administration of a standardized arithmetic task; participants ability to complete quick mental math.
Measured: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (month 6), and once at the final 12month appointment (month 12).
Secondary outcomes (9)
Differences in tryptophan-associated metabolite profiles pre, mid, and post intervention - Stool
Measurement of tryptophan-associate metabolite profiles via stool specimen.
Measured: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (month 6), and once at the final 12month appointment (month 12).
Differences in Bile Acid's (BA's) pre, mid, & post intervention - Stool
Measurement of BA's via stool specimen.
Measured: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (month 6), and once at the final 12month appointment (month 12).
Differences in Inflammatory markers pre, mid, & post intervention - Blood
Measurement of inflammatory markers via blood specimen.
Measured: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (month 6), and once at the final 12month appointment (month 12).
Differences in Alzheimer's Disease (AD) markers pre, mid, & post intervention - Blood [Time
Measurement of AD markers via blood specimen.
Measured: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (month 6), and once at the final 12month appointment (month 12).
Anthropometrics - BMI
Measurement of height(in) and weight(lbs), used to calculate body mass index (BMI)
Measured: Measured three times, once at each in-clinic appointment (week 0, month 6, month 12)
Questionnaire Data
Use of validated surveys to assess ingestive behaviours, social isolation, stress, health, physical activity, etc., self-reported by the participant at home.
Measured: Collected 3 times (1) before beginning the dietary supplement, (2) mid-study month 6, (3) end of study month 12.
Monthly Questionnaire Data
Collected once a month for the duration of the study (12months).
Measured: Collected 3 times (1) before beginning the dietary supplement, (2) mid-study month 6, (3) end of study month 12.
Anthropometrics - waist and hip circumference
Measurement of waist and hip circumference (cm)
Measured: Measured three times, once at each in-clinic appointment (week 0, month 6, & month 12)
Systolic and Diastolic Blood Pressure
Measurement of the pressure of circulating blood at rest
Measured: Measured three times, once at each in-clinic appointment (week 0, month 6, month 12).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2025
- Study start25 Nov 2025 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DeclineStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional Model
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Collaborators
- University of Parma, University College Cork, National Institute on Aging (NIA), University of California, Los Angeles
- Responsible party
- Sponsor
- Investigators
- Chris Gill, PhD, Principal investigator, Ulster University, Human Intervention Studies Unit, Coleraine, Co. Londonderry, BT52 1SA, United Kingdom.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07226674
- Sponsor's protocol ID
- REC/25/0046
- Other IDs
- 1R01AG081768-01, 5R01AG081768-02
- Acronym
- MAEVE
- Status last verified
- Nov 2025
- First submitted
- 7 Nov 2025
- Last updated
- 24 Nov 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 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MAEVE: Microbiota Mediated Flavonoid Metabolites for Cognitive Health
- ClinicalTrials.gov ID
- NCT07226674
- Acronym / sponsor ID
- MAEVE / REC/25/0046
- Conditions
- Cognitive Decline, Cognitive Dysfunction
- Keywords
- Polyphenols, Mediterranean Diet, Gut Microbiome, Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Collaborators
- University of Parma, University College Cork, National Institute on Aging (NIA), University of California, Los Angeles
- Study start
- 25 Nov 2025 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 10 Nov 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.
Globally, populations are ageing increasing the prevalence of Alzheimer's disease (AD), due to lack of effective treatments. The traditional Mediterranean diet, rich in fibre and polyphenols (PPs) can help prevent or delay cognitive dysfunction and preserve healthy brain structure and function. Cognitive decline is inversely associated with higher PP intakes (>421mg/day) i.e., total flavonoids, flavan-3-ols and flavonoid oligomers. The positive brain effects of flavonoid intake are likely mediated in part by gut microbial PP metabolites, consistent with the emerging role of the brain-gut microbiome (BGM) system in neurodegeneration. Our preliminary data indicate that circulating phenyl-γ-valerolactones (PVL), neuroprotective compounds exclusively produced by gut microbiota from flavan-3-ol rich foods18 are associated with delaying cognitive dysfunction. Intake of PPs change gut microbial composition and function, altering the physiology of the host's secondary bile acid (BA) pool through modulation of bacterial 7α-dehydroxylation of de-conjugated primary BAs into secondary BAs. This is noteworthy as 7α-dehydroxylation of BAs does not happen in the brain and because gut microbial BA metabolites have regulatory and signalling functions in the brain. The ratio between certain primary and secondary BAs is also dysregulated in AD with significantly lower serum concentrations of cholic acid (a primary BA) and increased levels of deoxycholic acid (a bacterially produced secondary BA). The increased ratio of cholic acid to deoxycholic acid is correlated with cognitive decline. Increased levels of tyrosine, tryptophan, purine, and tocopherol have also been identified in postmortem AD brains. However, specific pathways and mechanisms underlying these associations are unclear. In this multi-PI application by leaders in the field of BGM interactions, we leverage the collectively (NIH, HSC, SFI) funded Tripartite US-Ireland R\&D Partnership Program to determine the mechanisms involved in PP intake on maintaining healthier cognitive and brain function, as mediated by gut microbiota metabolites of PP and BAs in 50+ year old elderly with enhanced AD risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Interventional Model
| Arm | Type | Receives |
|---|---|---|
| Polyphenol Supplement | Experimental | Dietary Supplement: Polyphenol SupplementJuice Plus Essentials, Berry Blend Capsules |
| Placebo Supplement | Placebo comparator | Dietary Supplement: Placebo Supplement |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 50+ years
- BMI ≥ 25 kg/m2
- Enhanced risk of AD - defined as family history of AD, 1st degree family member
- Habitually consume suboptimal diets such as typical Western diet (i.e., high in animal products, refined carbohydrates and processed food).
- Subjects capable of and willing to comply with the protocol and to give their written informed consent.
Key exclusion criteria (18 listed)
- Cognitive impairment at time of recruitment into the study, as measured by the Mini Mental Status Exam (MMSE, score 25-30), and Clinical Dementia Rating (CDR, score=0) or Everyday Cognition Scale-12 (ECog-12, score<1.36 included).
- Pre-existing psychosis or psychiatric conditions.
- Currently receiving treatment for dementia.
- History of substance abuse or cerebrovascular events.
- Heavy use of tobacco (>1/2 pack per day)
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 |
|---|---|---|
| Polyphenol SupplementJuice Plus Essentials, Berry Blend Capsules | Dietary supplement | Polyphenol Supplement |
| Placebo SupplementMicronutrient matched placebo | Dietary supplement | Placebo Supplement |
Primary outcome
Differences in Polyphenol-derived metabolite concentrations pre, mid, & post intervention - stool
Time frame: Collected three times by the participant at home, once at baseline (week 0), once at mid-study (month 6), and once at the final 12month appointment (month 12)
Measurement of metabolomics via stool specimen.
Differences in Polyphenol-derived metabolite concentrations pre, mid, & post intervention - blood
Time frame: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (month 6), and once at the final 12month appointment (month 12).
Measurement of metabolomics via blood specimen.
Differences in microbiome levels pre, mid, & post intervention - Stool
Time frame: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (month 6), and once at the final 12month appointment (month 12).
16S RNA sequencing to measure microbiome levels via stool specimen.
Differences in microbiome levels pre & post intervention - Blood
Time frame: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (month 6), and once at the final 12month appointment (month 12).
16S RNA sequencing to measure microbiome levels via blood specimen.
Differences in microbiome levels pre, mid, & post intervention - Stool
Time frame: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (month 6), and once at the final 12month appointment (month 12).
Shotgun metagenomics, sequencing to measure microbiome levels via stool specimen.
Differences in microbiome levels pre, mid, & post intervention - Blood
Time frame: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (month 6), and once at the final 12month appointment (month 12).
Shotgun metagenomics, sequencing to measure microbiome levels via stool specimen.
Differences in Cognitive Measures pre, mid, & post intervention - Executive Function
Time frame: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (month 6), and once at the final 12month appointment (month 12).
Administration of a standardized Stroop Neuro-psychological test; participants ability to correctly identify colours when words are printed in conflicting ink colours.
Differences in Cognitive Measures pre, mid, & post intervention - Executive Function
Time frame: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (month 6), and once at the final 12month appointment (month 12).
Administration of a standardized Trails A \& B; participants ability to connect dots, in order, as quickly as possible.
Differences in Cognitive Measures pre, mid, & post intervention
Time frame: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (month 6), and once at the final 12month appointment (month 12).
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Differences in Cognitive Measures pre, mid, & post intervention
Time frame: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (month 6), and once at the final 12month appointment (month 12).
Administration of a standardized arithmetic task; participants ability to complete quick mental math.
9 secondary outcomes
Differences in tryptophan-associated metabolite profiles pre, mid, and post intervention - Stool
Time frame: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (month 6), and once at the final 12month appointment (month 12).
Differences in Bile Acid's (BA's) pre, mid, & post intervention - Stool
Time frame: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (month 6), and once at the final 12month appointment (month 12).
Differences in Inflammatory markers pre, mid, & post intervention - Blood
Time frame: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (month 6), and once at the final 12month appointment (month 12).
Differences in Alzheimer's Disease (AD) markers pre, mid, & post intervention - Blood [Time
Time frame: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (month 6), and once at the final 12month appointment (month 12).
Anthropometrics - BMI
Time frame: Measured three times, once at each in-clinic appointment (week 0, month 6, month 12)
Questionnaire Data
Time frame: Collected 3 times (1) before beginning the dietary supplement, (2) mid-study month 6, (3) end of study month 12.
Monthly Questionnaire Data
Time frame: Collected 3 times (1) before beginning the dietary supplement, (2) mid-study month 6, (3) end of study month 12.
Anthropometrics - waist and hip circumference
Time frame: Measured three times, once at each in-clinic appointment (week 0, month 6, & month 12)
Systolic and Diastolic Blood Pressure
Time frame: Measured three times, once at each in-clinic appointment (week 0, month 6, month 12).
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 24 Nov 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.
Chris Gill, PhD principal investigator
Ulster University, Human Intervention Studies Unit, Coleraine, Co. Londonderry, BT52 1SA, United Kingdom.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polyphenol Supplement in people with Cognitive Decline and Cognitive Dysfunction, 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 5 inclusion and 18 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 24 Nov 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?
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 Chris Gill, PhD (+44 28 7012 3181, c.gill@ulster.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in Polyphenol-derived metabolite concentrations pre, mid, & post intervention - stool (time frame: Collected three times by the participant at home, once at baseline (week 0), once at mid-study (month 6), and once at the final 12month appointment (month 12)). The study lists 10 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 24 Nov 2025.