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New treatment option for Cognitive Decline
Official title Microbiota Mediated Flavonoid Metabolites for Cognitive Health
ClinicalTrials.gov ID: NCT07226674
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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).
- people capable of and willing to comply with the protocol and to give their written informed consent.
You likely can't join if
- Cognitive impairment at time of recruitment into the study, as measured by the Mini Mental Status Exam (MMSE, score 25-30), and Clinical Dementia...
- 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 eligibility criteria
- 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).
- people capable of and willing to comply with the protocol and to give their written informed consent.
- 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Coleraine, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Coleraine, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.