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

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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