The Effect of Berry Extract Administration on Cognitive Health

NCT03236259 | Completed DMC

• 1 other identifier: Brainport-001
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Impairment; Overweight and Obesity

Outcome Measures

Primary Outcomes (3)

• Cognition

  test attention with STROOP

  6 months

• Cognition

  Test concentration with 'cijferdoorstreep test'

  6 months

• Cognition

  Test psychomotor speed with grooved pegboard

  6 months

Secondary Outcomes (5)

• vascular structure

  6 months

• Mood

  6 months

• Blood pressure

  6 months

• Liver function

  6 months

• flavo-enzyme

  6 months

Study Arms (3)

Brainport high dose

ACTIVE COMPARATOR

Dietary Supplement: Brainport high dose

Brainport low dose

ACTIVE COMPARATOR

Dietary Supplement: Brainport low dose

Placebo

PLACEBO COMPARATOR

Maltodextrin

Dietary Supplement: Placebo

Interventions

Brainport high dose DIETARY_SUPPLEMENT

berry extract, high dose. Daily ingestion of capsule

Brainport high dose

Brainport low dose DIETARY_SUPPLEMENT

Berry extract, low dose. Daily ingestion of capsule

Brainport low dose

Placebo DIETARY_SUPPLEMENT

Maltodextrin. Daily ingestion of capsule

Placebo

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy individuals
• Age between 40 and 60 years
• BMI 25 - 35 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• BioActor B.V.: collaborator

Study Sites (1)

Maastricht University Medical Center

Maastricht, Netherlands

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Overweight; Obesity

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2017
• First Posted: August 1, 2017
• Study Start: February 21, 2017
• Primary Completion: August 21, 2018
• Study Completion: August 21, 2018
• Last Updated: February 25, 2021

Record last verified: 2018-09

Locations

NL (1)