- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03793777
The Effect of Aronia Melanocarpa Extract on Cognitive Function
September 3, 2021 updated by: Maastricht University Medical Center
The Effect of Short-term Aronia Melanocarpa Extract Supplementation on Cognitive Function in Healthy Young Adults
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Limburg
-
Maastricht, Limburg, Netherlands, 6229ET
- Maastricht University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 31 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: placebo
microcrystalline cellulose supplementation
|
daily supplementation
|
|
Experimental: Aronia
aronia melanocarpa supplementation
|
daily supplementation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cognitive function
Time Frame: After 7 days of supplementation
|
CANTAB
|
After 7 days of supplementation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mood
Time Frame: After 7 days of supplementation
|
VAMS
|
After 7 days of supplementation
|
|
Biomarkers in blood and saliva
Time Frame: After 7 days of supplementation
|
BDNF & cortisol
|
After 7 days of supplementation
|
|
Vascular function
Time Frame: After 7 days of supplementation
|
SBP & DBP, PWA & PWV
|
After 7 days of supplementation
|
|
Microvasculature
Time Frame: After 7 days of supplementation
|
Fundus photography
|
After 7 days of supplementation
|
|
Subjective cognition
Time Frame: After 7 days of supplementation
|
Cognitive Failures Questionnaire
|
After 7 days of supplementation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Jogchum Plat, Prof, Maastricht University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 9, 2020
Primary Completion (Actual)
April 29, 2021
Study Completion (Actual)
April 29, 2021
Study Registration Dates
First Submitted
December 19, 2018
First Submitted That Met QC Criteria
January 2, 2019
First Posted (Actual)
January 4, 2019
Study Record Updates
Last Update Posted (Actual)
September 5, 2021
Last Update Submitted That Met QC Criteria
September 3, 2021
Last Verified
September 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- Brainport_002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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