NCT03793777

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 4, 2019

Completed
1.8 years until next milestone

Study Start

First participant enrolled

October 9, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2021

Completed
Last Updated

September 5, 2021

Status Verified

September 1, 2020

Enrollment Period

7 months

First QC Date

December 19, 2018

Last Update Submit

September 3, 2021

Conditions

Cognitive Function

Keywords

supplementationcognitioncognitive functionvascular functionmicrovasculature

Outcome Measures

Primary Outcomes (1)

  • Cognitive function

    CANTAB

    After 7 days of supplementation

Secondary Outcomes (5)

  • Mood

    After 7 days of supplementation

  • Biomarkers in blood and saliva

    After 7 days of supplementation

  • Vascular function

    After 7 days of supplementation

  • Microvasculature

    After 7 days of supplementation

  • Subjective cognition

    After 7 days of supplementation

Study Arms (2)

placebo

PLACEBO COMPARATOR

microcrystalline cellulose supplementation

Dietary Supplement: Placebo

Aronia

EXPERIMENTAL

aronia melanocarpa supplementation

Dietary Supplement: Aronia

Interventions

AroniaDIETARY_SUPPLEMENT

daily supplementation

Aronia
PlaceboDIETARY_SUPPLEMENT

daily supplementation

placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy young adults: ages between 18 and 35
  • BM between 18.5-30 kg/m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University

Maastricht, Limburg, 6229ET, Netherlands

Location

Related Publications (1)

  • Ahles S, Joris PJ, Plat J. Short-term Aronia melanocarpa extract supplementation improves cognitive performance: a randomized, double-blind, placebo-controlled cross-over study in healthy young adults. Eur J Nutr. 2024 Aug;63(5):1545-1553. doi: 10.1007/s00394-024-03381-3. Epub 2024 Apr 24.

    PMID: 38656355DERIVED

Study Officials

  • Jogchum Plat, Prof

    Maastricht University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
block randomization
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Cross-over study with 2 intervention conditions
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2018

First Posted

January 4, 2019

Study Start

October 9, 2020

Primary Completion

April 29, 2021

Study Completion

April 29, 2021

Last Updated

September 5, 2021

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)