NCT03236259CompletedNot Applicable
The Effect of Berry Extract Administration on Cognitive Health
Maastricht University Medical Center1 site in 1 country102 target enrollmentStarted: February 21, 2017Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 102
- Locations
- 1
- Primary Endpoint
- Cognition
Study Overview
Brief Summary
The purpose of this study is to investigate the effects of daily supplementation of Brainport for a period of 6 months on cognitive health.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •healthy individuals
- •Age between 40 and 60 years
- •BMI 25 - 35 kg/m2
Exclusion Criteria
- •History of severe cardiovascular, respiratory, urogenital, gastrointestinal/hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat). Dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological diseases, allergy, major surgery and /or laboratory assessments that might limit participation in or completion of the study protocol.
- •Use of medication that might have influence on endpoints (hypertension medication)
- •Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study in the 180 days prior to the study
- •Use of antibiotics in the 30 days prior to the start of the study
- •Use of antioxidants, minerals and vitamin supplements available in pharmacies, drugstores, food markets or in alternative medicine
- •Pregnancy, lactation
- •Abuse of products (> 20 alcoholic consumptions per week and drugs)
- •Weight gain or loss (> 3 kg in previous 3 months)
- •High physical activity (>4.5 hours of running/week)
- •History of any side effects towards intake of berries
Arms & Interventions
Placebo
Placebo Comparator
Maltodextrin
Intervention: Placebo (Dietary Supplement)
Brainport high dose
Active Comparator
Intervention: Brainport high dose (Dietary Supplement)
Brainport low dose
Active Comparator
Intervention: Brainport low dose (Dietary Supplement)
Outcomes
Primary Outcomes
Cognition
Time Frame: 6 months
test attention with STROOP
Secondary Outcomes
- Liver function(6 months)
- flavo-enzyme(6 months)
- Mood(6 months)
- vascular structure(6 months)
- Blood pressure(6 months)
Investigators
Study Sites (1)
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