Cognitive Impairment, Overweight and Obesity
Conditions
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.
Interventions
DIETARY_SUPPLEMENTBrainport high dose
berry extract, high dose. Daily ingestion of capsule
DIETARY_SUPPLEMENTBrainport low dose
Berry extract, low dose. Daily ingestion of capsule
DIETARY_SUPPLEMENTPlacebo
Maltodextrin. Daily ingestion of capsule
Sponsors
BioActor B.V.
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 60 Years
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. * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cognition | 6 months | test attention with STROOP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| vascular structure | 6 months | measure vascular structure with ultrasound. |
| Mood | 6 months | Test mood with visual analogue mood scale. 8 emotions are scored on a 1-10 scale. |
| Blood pressure | 6 months | — |
| Liver function | 6 months | analysis of alkaline phosphatase, alanine aminotransferase, aspartaat aminotransferase, bilirubine, gamma-glutamyltransferase to determine liver function. |
| flavo-enzyme | 6 months | monoamine oxidase B analysis |
Countries
Netherlands
Outcome results
None listed