Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 17 of 82 for:    extract | maltodextrin

The Effect of Berry Extract Administration on Cognitive Health

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03236259
Recruitment Status : Completed
First Posted : August 1, 2017
Last Update Posted : September 14, 2018
Sponsor:
Collaborator:
BioActor B.V.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cognitive Impairment Overweight and Obesity Dietary Supplement: Brainport high dose Dietary Supplement: Brainport low dose Dietary Supplement: Placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : February 21, 2017
Actual Primary Completion Date : August 21, 2018
Actual Study Completion Date : August 21, 2018

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03236259


Locations
Layout table for location information
Netherlands
Maastricht University Medical Center
Maastricht, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
BioActor B.V.

Layout table for additonal information
Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT03236259     History of Changes
Other Study ID Numbers: Brainport-001
First Posted: August 1, 2017    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Overweight
Cognitive Dysfunction
Body Weight
Signs and Symptoms
Cognition Disorders
Neurocognitive Disorders
Mental Disorders