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The Effect of Berry Extract Administration on Cognitive Health

Maastricht University Medical Centre (MUMC) logo

Maastricht University Medical Centre (MUMC)

Status

Completed

Conditions

Cognitive Impairment
Overweight and Obesity

Treatments

Dietary Supplement: Placebo
Dietary Supplement: Brainport low dose
Dietary Supplement: Brainport high dose

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03236259
Brainport-001

Details and patient eligibility

About

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

Enrollment

102 patients

Sex

All

Ages

40 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

102 participants in 3 patient groups, including a placebo group

Brainport high dose
Active Comparator group
Treatment:
Dietary Supplement: Brainport high dose
Brainport low dose
Active Comparator group
Treatment:
Dietary Supplement: Brainport low dose
Placebo
Placebo Comparator group
Description:
Maltodextrin
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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