The Effect of Berry Extract Administration on Cognitive Health

• Sponsor: Maastricht University Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03236259
• Collaborator: BioActor B.V. (Industry)
• Enrollment: 102
• Location: 1
• Arms: 3
• Actual Duration (Months): 17.9
• Patients Per Site Per Month: 5.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cognitive Impairment; Overweight and Obesity	Dietary Supplement: Brainport high dose; Dietary Supplement: Brainport low dose; Dietary Supplement: Placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 102 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: The Effect of Berry Extract Administration on Cognitive Health
• Actual Study Start Date: Feb 21, 2017
• Actual Primary Completion Date: Aug 21, 2018
• Actual Study Completion Date: Aug 21, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Brainport high dose	Dietary Supplement: Brainport high dose; berry extract, high dose. Daily ingestion of capsule
Active Comparator: Brainport low dose	Dietary Supplement: Brainport low dose; Berry extract, low dose. Daily ingestion of capsule
Placebo Comparator: Placebo Maltodextrin	Dietary Supplement: Placebo; Maltodextrin. Daily ingestion of capsule

Outcome Measures

Primary Outcome Measures

1. Cognition [6 months]

   test attention with STROOP

2. Cognition [6 months]

   Test concentration with 'cijferdoorstreep test'

3. Cognition [6 months]

   Test psychomotor speed with grooved pegboard

Secondary Outcome Measures

1. vascular structure [6 months]

   measure vascular structure with ultrasound.

2. Mood [6 months]

   Test mood with visual analogue mood scale. 8 emotions are scored on a 1-10 scale.

3. Blood pressure [6 months]

4. Liver function [6 months]

   analysis of alkaline phosphatase, alanine aminotransferase, aspartaat aminotransferase, bilirubine, gamma-glutamyltransferase to determine liver function.

5. flavo-enzyme [6 months]

   monoamine oxidase B analysis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 60 Years
• Sexes Eligible for Study: 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.

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maastricht University Medical Center	Maastricht		Netherlands

Sponsors and Collaborators

• Maastricht University Medical Center
• BioActor B.V.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maastricht University Medical Center
• ClinicalTrials.gov Identifier: NCT03236259
• Other Study ID Numbers: Brainport-001
• First Posted: Aug 1, 2017
• Last Update Posted: Feb 25, 2021
• Last Verified: Sep 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Overweight

Study Results

No Results Posted as of Feb 25, 2021