The Effect of Berry Extract Administration on Cognitive Health

NCT ID: NCT03236259

Last Updated: 2021-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-21

Study Completion Date

2018-08-21

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.

Detailed Description

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Conditions

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Cognitive Impairment Overweight and Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Brainport high dose

Group Type ACTIVE_COMPARATOR

Brainport high dose

Intervention Type DIETARY_SUPPLEMENT

berry extract, high dose. Daily ingestion of capsule

Brainport low dose

Group Type ACTIVE_COMPARATOR

Brainport low dose

Intervention Type DIETARY_SUPPLEMENT

Berry extract, low dose. Daily ingestion of capsule

Placebo

Maltodextrin

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin. Daily ingestion of capsule

Interventions

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Brainport high dose

berry extract, high dose. Daily ingestion of capsule

Intervention Type DIETARY_SUPPLEMENT

Brainport low dose

Berry extract, low dose. Daily ingestion of capsule

Intervention Type DIETARY_SUPPLEMENT

Placebo

Maltodextrin. Daily ingestion of capsule

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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BioActor B.V.

INDUSTRY

Sponsor Role collaborator

Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Maastricht University Medical Center

Maastricht, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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Brainport-001

Identifier Type: -

Identifier Source: org_study_id

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