Polyphenol Supplement for Cognitive Impairment
(MAEVE Trial)
Trial Summary
What is the purpose of this trial?
Globally, populations are aging thereby increasing healthcare burden, overall cognitive impairment, and dementia including Alzheimers diseases (AD). The lack of effective treatments makes it essential to develop new strategies for healthy cognitive aging, including interventions to slow or prevent cognitive decline. A traditional Mediterranean diet, rich in polyphenols (PPs), may prevent or delay the onset of cognitive dysfunction in older adults, preserving healthy brain structure and function, and lowering the risk of AD. These effects, mediated in part by gut microbiome-derived PP metabolites, highlight the role alterations in the brain-gut microbiome system play in neurodegeneration. Moreover, high levels of circulating phenyl-y-valerolactones, neuroprotective compounds, exclusively produced by gut microbiota from flavan-3-ol-rich foods (e.g., cocoa, tea, berries) are associated with delaying the onset of cognitive dysfunction in older adults. Intake of such PPs can also change gut microbial composition and function, altering the physiology of the hosts secondary bile acid (BA) pool, affecting regulatory and signaling functions in the brain as well as cognitive decline and AD. The investigators hypothesize that, in older adults with enhanced AD risk, dietary intake of PPs maintains healthier brain features and cognitive function, and that this beneficial effect is mediated by gut microbiota metabolites of PPs and BAs. In this multi-PI application by leaders in the field of brain-gut microbiome interactions, the investigators will conduct a year-long, multi-center, randomized double-blind placebo-controlled study in 300 older adults in the United States (validation sample of 100 from Northern Ireland) who are at enhanced risk of developing AD. Ultimately, the investigators will establish the protective effects of regular dietary PP intake on cognitive function and on brain-gut microbiome interactions, ideally allowing the development of effective dietary regimes to prevent of delay the onset of AD in at-risk elderly, thereby reducing cognitive decline and healthcare costs. Participants will be asked to provide information about their diet, mood, and behaviors via food diaries, physical body measures (e.g. height, weight, etc.), and online questionnaires collected before each in-clinic appointment, as well as monthly online questionnaires. MR imaging will be collected on participants to assess neurocognitive changes as a result of the supplement. Participants will be asked to provide both stool and blood samples. Participants will be randomly assigned to either the Juice Plus+ intervention group or the placebo treatment group and then asked to take their respective supplement 4 pills twice a day. All participants will be asked to come in for 4 in-clinic appointments, including 3 brain MRI scans and 3 cognitive testing appointments, collect 3 stool samples with corresponding diet diaries, and provide 3 blood samples over the course of 12 months. Participants will also meet with a nutritionist 3 times over the 12 months to discuss diet to ensure study eligibility and any questions about the supplement.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you have recently changed your use of psychoactive medications or other medications that interfere with the study's outcomes, you may not be eligible to participate.
What data supports the effectiveness of the polyphenol supplement treatment for cognitive impairment?
Research suggests that diets rich in polyphenols, like those found in cocoa, may help reduce the risk of cognitive decline and Alzheimer's disease. Some studies have shown that polyphenols can improve cognitive function, especially in older adults, by potentially reducing inflammation in the brain.12345
Is the Polyphenol Supplement safe for humans?
Polyphenols, found in foods like cocoa, grapes, and blueberries, have been studied for their health benefits, including cognitive support. While research is promising, more studies are needed to fully understand their safety and effects in humans. Current evidence suggests they are generally safe, but it's important to consider individual health conditions and consult with a healthcare provider.15678
How is the polyphenol supplement treatment different from other treatments for cognitive impairment?
The polyphenol supplement is unique because it uses naturally occurring compounds found in plants, like grapes and blueberries, which may help improve cognitive function by reducing neuroinflammation and oxidative stress. Unlike some other treatments, it focuses on dietary intake and its potential benefits for cognitive health, although more research is needed to confirm its effectiveness.12489
Research Team
Arpana Church, PhD
Principal Investigator
The Regents of the University of California, Los Angeles
Eligibility Criteria
This trial is for adults over 50 who are overweight or obese, speak English well, and eat a Western diet high in animal products and processed foods. They must be at higher risk of Alzheimer's due to family history but cannot participate if they have certain conditions that the provided information does not specify.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either the Juice Plus+ intervention or placebo, with regular monitoring and assessments
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Polyphenol Supplement
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Los Angeles
Lead Sponsor