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MAEVENCT07226674

Microbiota Mediated Flavonoid Metabolites for Cognitive Health

StatusRecruiting
PhaseNot applicable
Primary completion (estimated)

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 ↗

  1. 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
  2. Minor Start date: Nov 10, 2025 to Nov 25, 2025v2
  3. 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
Show 4 moreShow less
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