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
- Polyphenol Supplement (supplement), Placebo Supplement (supplement)
- How long the study runs
- Study runs about 26 months (dates as stated)
- About the drug or intervention
- Polyphenol Supplement — supplement: Juice Plus Essentials, Berry Blend Capsules · Placebo Supplement — supplement: Micronutrient matched placebo
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 50 Years and over
- Who
- All
- Number of participants
- 100
- Started
- 2025-11-25
- Last checked
- 2025-11
Plain English Summary
What is this study?
- • Testing a new treatment for cognitive decline
- • NA - 100 participants
- • Globally, populations are ageing increasing the prevalence of Alzheimer's disease (AD), due to lack of effective treatments
Who can take part?
- • Ages 50 Years and over
- • Diagnosed with cognitive decline
Where?
- • Coleraine - Ulster University, Human Intervention Studies Unit
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
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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
- ✓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...
- ✓Subjects capable of and willing to comply with the protocol and to give their written agreement to take part.
Who cannot take part
- ✗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.
See the full criteria
Where Is This Study? (1 UK site)
Ulster University, Human Intervention Studies Unit
Coleraine BT52 1SA, United Kingdom
How to Get in Touch
Chris Gill, PhD
Sponsor contactCONTACT
Aoife Caffrey, PhD
Sponsor contactCONTACT