MAEVENCT07226674
Microbiota Mediated Flavonoid Metabolites for Cognitive Health
At risk: Primary completion moved at least 5 months later.
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Record History
All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗
Notable Start date changed from estimate of Nov 25, 2025 to Mar 3, 2026 Show 6 more changesShow less
- Primary endpoints: details revised at 10 of 10 entries
- Eligibility criteria shortened, about 4 words
- Primary completion pushed from Jun 2027 to Dec 20, 2027
- Study completion date: Jan 2028 to Jan 20, 2028
- Secondary endpoints: details revised at 4 of 9 entries
- Collaborators shortened, about 16 words
- Minor Start date: Nov 10, 2025 to Nov 25, 2025v2
- Study First Submitted
- Notable: the plan changed
- Minor: routine updates
Endpoints
Primary
Differences in Polyphenol-derived metabolite concentrations pre, mid, & post intervention - stool
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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 (9)
Differences in tryptophan-associated metabolite profiles pre, mid, and post intervention - Stool
Differences in Bile Acid's (BA's) pre, mid, & post intervention - Stool
Differences in Inflammatory markers pre, mid, & post intervention - Blood
Differences in Alzheimer's Disease (AD) markers pre, mid, & post intervention - Blood [Time
Anthropometrics - BMI
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Questionnaire Data
Monthly Questionnaire Data
Anthropometrics - waist and hip circumference
Systolic and Diastolic Blood Pressure
Arms and interventions
Polyphenol SupplementExperimental
Juice Plus Essentials, Berry Blend Capsules
Placebo SupplementPlacebo comparator
Dietary supplements: Polyphenol Supplement, Placebo Supplement
Sites
1 site in 1 country
- Ulster University, Human Intervention Studies UnitColeraine, United Kingdom