Clinical trial NCT03793777: The Effect of Aronia Melanocarpa Extract on Cognitive Function
Official title: The Effect of Short-term Aronia Melanocarpa Extract Supplementation on Cognitive Function in Healthy Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Function
Keywords: supplementation
cognition
cognitive function
vascular function
microvasculature
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: BioActor B.V.
First posted: 2019-01-04
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Cross-over study with 2 intervention conditions
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cognitive function
timeFrame: After 7 days of supplementation
Secondary outcomes:
measure: Mood
timeFrame: After 7 days of supplementation
measure: Biomarkers in blood and saliva
timeFrame: After 7 days of supplementation
measure: Vascular function
timeFrame: After 7 days of supplementation
measure: Microvasculature
timeFrame: After 7 days of supplementation
measure: Subjective cognition
timeFrame: After 7 days of supplementation
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
state: Limburg
Study officials:
affiliation: Maastricht University
name: Jogchum Plat, Prof
role: PRINCIPAL_INVESTIGATOR
References: