The main objective of this study is to study the effect of Aronia Melanocarpa intake on cognitive performance. The secondary objectives are to investigate effects of AME on eye health.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
cognitief functioneren
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
cognitive performance will be measured through a digital test battery
(Cambridge neuropsychological test automated battery; CANTAB). These tests are
aimed at three domains: attention & psychomotor speed, memory, and executive
function
Secondary outcome
Moreover, we are researching eye health both objectively and subjectively by
measuring tear production (Schirmer's test) and osmolarity, as well as
subjective eye fatigue (subjective eye fatigue questionnaire).
Background summary
The shift of on-site education/working to online education/working has had a
detrimental impact on motivation to study or work and ultimately on mental
health. Moreover, online education has been shown to have a negative effect on
concentration, learning, and academic performance. Stress in the workplace is
an increasing problem, leading to decreased productivity and overall well-being
of working adults. Consequently, there is a great interest in improving
cognitive performance, including memory and attention. Moreover, digital screen
use is increasing rapidly resulting in fatigued/dry eyes and/or eye strain.
Previous studies in young adults have mainly focused on acute or short-term
(e.g. 1 week) effects of anthocyanin supplementation on cognitive performance.
Our research hypothesis of the current study is that long term (6 weeks) AME
supplementation affects domains of cognitive performance. Moreover, AME
supplementation is expected to have a beneficial effect on parameters of eye
health related to screen use.
Study objective
The main objective of this study is to study the effect of Aronia Melanocarpa
intake on cognitive performance. The secondary objectives are to investigate
effects of AME on eye health.
Study design
randomized, double-blind, placebo-controlled, cross-over trial
Intervention
65 mg Aronia Melanocarpa extract (AME) and placebo (cellulose) will be ingested
for 2x 6 weeks by use of capsules
Study burden and risks
The total study duration will be 18 weeks, including the wash-out period of 6
weeks. During the study, blood samples will be collected (< 500 mL in total),
which may cause a hematoma or bruise. Other measurements are not expected to
cause side effects. Subjects will have a time investment of 9.5 hours
(screening, four test days). A similar dose of AME has already been used in
previous studies, with no side effects.
Universiteitssingel 50
Maastricht 6229ER
NL
Universiteitssingel 50
Maastricht 6229ER
NL
Listed location countries
Age
Inclusion criteria
men and women, 18-35 years old, BMI 18-30, non-smoking
Exclusion criteria
smoking, contact lens wearers, past refractive surgery, severe medical
conditions, use of dietary supplements or medication affecting main outcomes,
drug or alcohol abuse
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 | NCT(nognietbekend) |
| CCMO | NL81486.068.22 |