The Effect of Aronia Melanocarpa Extract on Cognitive Function

Sponsor

Maastricht University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT03793777

Collaborator

BioActor B.V. (Industry)

Enrollment

Location

Arms

6.6

Actual Duration (Months)

5.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Cognitive Function	Dietary Supplement: Aronia Dietary Supplement: Placebo	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Cross-over study with 2 intervention conditionsCross-over study with 2 intervention conditions

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

block randomization

Primary Purpose:

Prevention

Official Title:

The Effect of Short-term Aronia Melanocarpa Extract Supplementation on Cognitive Function in Healthy Young Adults

Actual Study Start Date :

Oct 9, 2020

Actual Primary Completion Date :

Apr 29, 2021

Actual Study Completion Date :

Apr 29, 2021

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: placebo microcrystalline cellulose supplementation	Dietary Supplement: Placebo daily supplementation
Experimental: Aronia aronia melanocarpa supplementation	Dietary Supplement: Aronia daily supplementation

Arm

Intervention/Treatment

Placebo Comparator: placebo

microcrystalline cellulose supplementation

Dietary Supplement: Placebo

daily supplementation

Experimental: Aronia

aronia melanocarpa supplementation

Dietary Supplement: Aronia

daily supplementation

Outcome Measures

Primary Outcome Measures

Cognitive function [After 7 days of supplementation]
CANTAB

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maastricht University	Maastricht	Limburg	Netherlands	6229ET

Sponsors and Collaborators

Maastricht University Medical Center
BioActor B.V.

Investigators

Principal Investigator: Jogchum Plat, Prof, Maastricht University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Maastricht University Medical Center

ClinicalTrials.gov Identifier:

NCT03793777

Other Study ID Numbers:

Brainport_002

First Posted:

Jan 4, 2019

Last Update Posted:

Sep 5, 2021

Last Verified:

Sep 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Maastricht University Medical Center

Study Results

No Results Posted as of Sep 5, 2021