The Effect of Berry Extract Administration on Cognitive Health

Cognitive Impairment Clinical Trial

Official title:

The Effect of Berry Extract Administration on Cognitive Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03236259
• Other study ID #: Brainport-001
• Status: Completed
• Phase: N/A
• Start date: February 21, 2017
• Est. completion date: August 21, 2018

Study information

• Verified date: September 2018
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: August 21, 2018
• Est. primary completion date: August 21, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Impairment
• Overweight
• Overweight and Obesity

Intervention

Dietary Supplement:
• Brainport high dose
berry extract, high dose. Daily ingestion of capsule
• Brainport low dose
Berry extract, low dose. Daily ingestion of capsule
• Placebo
Maltodextrin. Daily ingestion of capsule

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	BioActor B.V.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognition	test attention with STROOP	6 months
Primary	Cognition	Test concentration with 'cijferdoorstreep test'	6 months
Primary	Cognition	Test psychomotor speed with grooved pegboard	6 months
Secondary	vascular structure	measure vascular structure with ultrasound.	6 months
Secondary	Mood	Test mood with visual analogue mood scale. 8 emotions are scored on a 1-10 scale.	6 months
Secondary	Blood pressure		6 months
Secondary	Liver function	analysis of alkaline phosphatase, alanine aminotransferase, aspartaat aminotransferase, bilirubine, gamma-glutamyltransferase to determine liver function.	6 months
Secondary	flavo-enzyme	monoamine oxidase B analysis	6 months