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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03793777
Other study ID # Brainport_002
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 9, 2020
Est. completion date April 29, 2021

Study information

Verified date September 2020
Source Maastricht University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

There is a great interest in improving cognitive performance, including memory and attention. Improved attention is desirable for a large group of people because it is linked to improved performance . Students and professionals can benefit from improved attention and thus performance in academic and other work environments. In addition, cognitive functioning also plays an important role in sports. Various cognitive skills, including attention, reaction time and motor function, have shown that they can influence sport performance. A completely natural supplement with aronia melanocarpa extract could be a promising way to naturally improve cognitive performance.


Description:

There is a great interest in improving cognitive performance, including memory and attention. Improved attention is desirable for a large group of people because it is linked to improved performance. Students and professionals can benefit from improved attention and thus performance in academic and other work environments. In addition, cognitive functioning also plays an important role in sports. Various cognitive skills, including attention, reaction time and motor function, have shown that they can influence sport performance. A completely natural supplement with aronia melanocarpa extract could be a promising way to naturally improve cognitive performance. The product in this study is aronia melanocarpa which contains polyphenols. A limited number of clinical studies have already been carried out to see the effect of similar products on cognitive functioning. However, these studies have often been done in older study populations or over a longer period of time. In this study, in healthy adolescents (ages between the 18-35 and with a BMI between 18.5 and 30), the investigators want to test the short term (7 days) effect of aronia melanocarpa extract on cognitive functioning. The investigators will also test the effect of supplementation on the particpant's mood, vascular function, blood biomarkers, retinal vasculature, and subjective cognition.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date April 29, 2021
Est. primary completion date April 29, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - Healthy young adults: ages between 18 and 35 - BM between 18.5-30 kg/m2 Exclusion Criteria: - Current use of (antioxidant) dietary supplements and not willing to quit for the duration of the study duration - Pre-existing or history of neurological illness - High blood pressure (>140 systolic and/or >90 diastolic mmHg) - Use of medication that might have influence on endpoints (e.g. antidepressant) - Known pregnancy or lactation - Food allergy to the study product - Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study, to be decided by the principle investigator, in the 180 days prior to the study - Abuse of products (> 20 alcoholic consumptions per week and drug usage) - Participation in a scientific intervention study which may interfere with this study in the 180 days prior to this study

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Aronia
daily supplementation
Placebo
daily supplementation

Locations

Country Name City State
Netherlands Maastricht University Maastricht Limburg

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 Cognitive function CANTAB After 7 days of supplementation
Secondary Mood VAMS After 7 days of supplementation
Secondary Biomarkers in blood and saliva BDNF & cortisol After 7 days of supplementation
Secondary Vascular function SBP & DBP, PWA & PWV After 7 days of supplementation
Secondary Microvasculature Fundus photography After 7 days of supplementation
Secondary Subjective cognition Cognitive Failures Questionnaire After 7 days of supplementation
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