The Effect of Berry Extract Administration on Cognitive Health

Not Applicable

Completed

• Conditions: Cognitive Impairment; Overweight and Obesity
• Interventions: Dietary Supplement: Brainport low dose; Dietary Supplement: Brainport high dose; Dietary Supplement: Placebo

• Registration Number: NCT03236259
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-21
• Study First Submitted: 2017-07-20
• Study First Submitted QC: 2017-07-31
• Study First Posted: 2017-08-01
• Primary Completion: 2018-08-21
• Study Completion: 2018-08-21
• Status Verified: 2018-09
• Last Update Submitted: 2021-02-23
• Last Update Posted: 2021-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brainport low dose	Brainport low dose	-
Brainport high dose	Brainport high dose	-
Placebo	Placebo	Maltodextrin

Primary Outcome Measures

Name	Time	Method
Cognition	6 months	Test psychomotor speed with grooved pegboard

Secondary Outcome Measures

Name	Time	Method
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
Mood	6 months	Test mood with visual analogue mood scale. 8 emotions are scored on a 1-10 scale.
vascular structure	6 months	measure vascular structure with ultrasound.
Blood pressure	6 months

Trial Locations

Locations (1)

Maastricht University Medical Center; 🇳🇱 Maastricht, Netherlands