The Effect of Berry Extract Administration on Cognitive Health

Study Overview
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Brief Summary
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The purpose of this study is to investigate the effects of daily supplementation of Brainport for a period of 6 months on cognitive health.

Official Title
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The Effect of Berry Extract Administration on Cognitive Health

Conditions
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Cognitive Impairment, Overweight and Obesity

Intervention / Treatment
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* Dietary Supplement: Brainport high dose
* Dietary Supplement: Brainport low dose
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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. Diabetes 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) Smoking 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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Brainport high dose<br> | Dietary Supplement: Brainport high dose<br>* berry extract, high dose. Daily ingestion of capsule<br>|
| Active Comparator: Brainport low dose<br> | Dietary Supplement: Brainport low dose<br>* Berry extract, low dose. Daily ingestion of capsule<br>|
| Placebo Comparator: Placebo<br>Maltodextrin | Dietary Supplement: Placebo<br>* Maltodextrin. Daily ingestion of capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognition | test attention with STROOP | 6 months | 
| Cognition | Test concentration with 'cijferdoorstreep test' | 6 months | 
| Cognition | Test psychomotor speed with grooved pegboard | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vascular structure | measure vascular structure with ultrasound. | 6 months | 
| Mood | Test mood with visual analogue mood scale. 8 emotions are scored on a 1-10 scale. | 6 months | 
| Blood pressure |  | 6 months | 
| Liver function | analysis of alkaline phosphatase, alanine aminotransferase, aspartaat aminotransferase, bilirubine, gamma-glutamyltransferase to determine liver function. | 6 months | 
| flavo-enzyme | monoamine oxidase B analysis | 6 months |