The Effect of Berry Extract Administration on Cognitive Health
Primary Purpose
Cognitive Impairment, Overweight and Obesity
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Brainport high dose
Brainport low dose
Placebo
Sponsored by

About this trial
This is an interventional prevention trial for Cognitive Impairment
Eligibility Criteria
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
Sites / Locations
- Maastricht University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Brainport high dose
Brainport low dose
Placebo
Arm Description
Maltodextrin
Outcomes
Primary Outcome Measures
Cognition
test attention with STROOP
Cognition
Test concentration with 'cijferdoorstreep test'
Cognition
Test psychomotor speed with grooved pegboard
Secondary Outcome Measures
vascular structure
measure vascular structure with ultrasound.
Mood
Test mood with visual analogue mood scale. 8 emotions are scored on a 1-10 scale.
Blood pressure
Liver function
analysis of alkaline phosphatase, alanine aminotransferase, aspartaat aminotransferase, bilirubine, gamma-glutamyltransferase to determine liver function.
flavo-enzyme
monoamine oxidase B analysis
Full Information
NCT ID
NCT03236259
First Posted
July 20, 2017
Last Updated
February 23, 2021
Sponsor
Maastricht University Medical Center
Collaborators
BioActor B.V.
1. Study Identification
Unique Protocol Identification Number
NCT03236259
Brief Title
The Effect of Berry Extract Administration on Cognitive Health
Official Title
The Effect of Berry Extract Administration on Cognitive Health
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
February 21, 2017 (Actual)
Primary Completion Date
August 21, 2018 (Actual)
Study Completion Date
August 21, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
BioActor B.V.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairment, Overweight and Obesity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brainport high dose
Arm Type
Active Comparator
Arm Title
Brainport low dose
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Maltodextrin
Intervention Type
Dietary Supplement
Intervention Name(s)
Brainport high dose
Intervention Description
berry extract, high dose. Daily ingestion of capsule
Intervention Type
Dietary Supplement
Intervention Name(s)
Brainport low dose
Intervention Description
Berry extract, low dose. Daily ingestion of capsule
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Maltodextrin. Daily ingestion of capsule
Primary Outcome Measure Information:
Title
Cognition
Description
test attention with STROOP
Time Frame
6 months
Title
Cognition
Description
Test concentration with 'cijferdoorstreep test'
Time Frame
6 months
Title
Cognition
Description
Test psychomotor speed with grooved pegboard
Time Frame
6 months
Secondary Outcome Measure Information:
Title
vascular structure
Description
measure vascular structure with ultrasound.
Time Frame
6 months
Title
Mood
Description
Test mood with visual analogue mood scale. 8 emotions are scored on a 1-10 scale.
Time Frame
6 months
Title
Blood pressure
Time Frame
6 months
Title
Liver function
Description
analysis of alkaline phosphatase, alanine aminotransferase, aspartaat aminotransferase, bilirubine, gamma-glutamyltransferase to determine liver function.
Time Frame
6 months
Title
flavo-enzyme
Description
monoamine oxidase B analysis
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Maastricht University Medical Center
City
Maastricht
Country
Netherlands
12. IPD Sharing Statement
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The Effect of Berry Extract Administration on Cognitive Health
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