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OpenTrials
Completed

NCT Number: NCT03236259

The Effect of Berry Extract Administration on Cognitive Health

The purpose of this study is to investigate the effects of daily supplementation of Brainport for a period of 6 months on cognitive health.

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Key information

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Center

Maastricht, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brainport high dose

Dietary Supplement

berry extract, high dose. Daily ingestion of capsule

Brainport low dose

Dietary Supplement

Berry extract, low dose. Daily ingestion of capsule

Placebo

Dietary Supplement

Maltodextrin. Daily ingestion of capsule

Primary outcomes

  1. Cognition

    Time frame: 6 months

    test attention with STROOP

  2. Cognition

    Time frame: 6 months

    Test concentration with 'cijferdoorstreep test'

  3. Cognition

    Time frame: 6 months

    Test psychomotor speed with grooved pegboard

Secondary outcomes

  1. vascular structure

    Time frame: 6 months

    measure vascular structure with ultrasound.

  2. Mood

    Time frame: 6 months

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

  3. Blood pressure

    Time frame: 6 months

  4. Liver function

    Time frame: 6 months

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

  5. flavo-enzyme

    Time frame: 6 months

    monoamine oxidase B analysis

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • BioActor B.V.

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 1, 2017
Registry last updated
Feb 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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