With this research we look at the short-term effects of an aronia malanocarpa extract on cognitive functioning in healthy young adults compared to placebo.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Cognitief functioneren
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The short term (7 days) effect of supplementation on cognitive functioning
Secondary outcome
The short term (7 days) effect of supplementation on blood and saliva biomarkers
The short term (7 days) effect of supplementation on mood
The short term (7 days) effect of supplementation on vascular function.
The short term (7 days) effect of supplementation on microvasculature of the eye
The short term (7 days) effect of supplementation on subjective cognition
Background 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 (Vast, Young & Thomas, 2010).
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 (Baker, Nuccio & Jeukendrup, 2014). 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 extract, which contains
polyphenols. A limited number of clinical studies have already been carried out
to see the effect of this products and simular products on cognitive
functioning. However, these studies have often been done in older study
populations, 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), we want to test the short term (7 days) effect of aronia
melanocarpa extract on cognitive functioning. We will also test the effect of
supplementation on the participant's mood, subjective cognition, vascular
function, microvasculature of the eye, biomarker level in the blood and saliva,
as well as the blood pressure.
The study product is aronia malanocarpa (with an anthocyanin content of 24%).
Studies with aronia malanocarpa have shown positive indications with regard to
cognitive functioning, but this has not been tested in healthy young adults.
Study objective
With this research we look at the short-term effects of an aronia malanocarpa
extract on cognitive functioning in healthy young adults compared to placebo.
Study design
Randomized, double-blind, placebo-controlled cross-over study
Intervention
Subjects are randomly assigned to receive the intervention conditions in random
order. All subjects are randomly assigned to start one of the two conditions
(placebo, aronia melanocarpa). Each condition consists of taking supplements
for 7 days (30 minutes before breakfast) after which a wash-out period of 2
weeks follows and the remaining condition, which again consists of 7 days
supplementation, is started.
Study burden and risks
Participation in the study is a time investment in which some food products
have to be avoided, also a food diary must be filled out 4 times and a logbook
to specify the times of the intake of the capsules also needs to be filled out
for 7 days at a time during the two experimental conditions.
The dosage of aronia melanocarpa used in this study has no known side effects
based on previous human research.
Also for the intake of the placebo product, cellulose, no side effects are
known from previous human research.
For the intake of the Aronia extract no side effects are know from previous
human research,
Blood collection: risk of local hematoma, bruise and / or pain.
saliva collection: no risks
Cognitive test battery: no risks
Filling out the questionnaires, logbook and food diary: no risks
Vascular function assessment: no risks
fundus photography: no risks
Gaetano martinolaan 85
Maastricht 6229 GS
NL
Gaetano martinolaan 85
Maastricht 6229 GS
NL
Listed location countries
Age
Inclusion criteria
Healthy young adults: ages between 18 and 35, BMI between 18.5-30 kg/m2
Exclusion criteria
Medicine usage that could influence the endpoint of the study
Pregnancy or lactating
Known allergies for berries
High blood pressure (>140 systolic and/or >90 diastolic mmHg)
Usage of more than 20 alcoholic consumptions a week
Drug usage
Supplement usage
Participation in a scientific intervention study which may interfere with this
study in the 180 days prior to this study
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
ClinicalTrials.gov | NCT03793777 |
CCMO | NL67045.068.18 |