The primary objectives are to investigate effects of AME intake on brain vascular function and insulin-sensitivity in cognitive-control brain areas, while we will also evaluate changes in cognitive function (secondary objective).
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
cognitief functioneren
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Cerebral blood flow responses before and after intranasal insulin
administration will be non-invasively quantified by MRI.
Secondary outcome
Furthermore, effects of AME on cognitive performance will be assessed.
Exploratory outcomes are other potential mechanisms responsible for observed
effects on cognitive function, and other perceivable benefits such as vascular
improvements and metabolic markers.
Background summary
Previously, we have observed beneficial effects of Aronia Melanocarpa extract
(AME) supplementation on cognitive performance in healthy middle-aged adults.
However, underlying mechanisms have not yet been addressed. In addition,
effects of AME are unknown in subjects at increased risk of cognitive
impairment. We hypothesize that supplementation with AME enhances (regional)
brain vascular function and brain insulin-sensitivity, thereby improving
cognitive function of subjects at increased risk of cognitive impairment.
Study objective
The primary objectives are to investigate effects of AME intake on brain
vascular function and insulin-sensitivity in cognitive-control brain areas,
while we will also evaluate changes in cognitive function (secondary
objective).
Study design
The present study is a randomized, double-blind, placebo-controlled, cross-over
trial consisting of two study groups and a pre- and post-test day in both study
arms.
Intervention
Participants will receive, in random order, daily 160 mg of an
anthocyanin-rich Aronia extract (containing 40 mg anthocyanins) or a placebo
for six weeks, separated by a 12-week wash-out.
Study burden and risks
The total study duration will be 24 weeks, including the wash-out period of 12
weeks. During the study, blood samples will be collected (< 500 mL in total),
which may cause a hematoma or bruise. Furthermore, ASL MRI is a non-invasive
method, without significant risks. No contrast medication or radioactive tracer
will be administered. The use of insulin as nasal spray is safe and already
used in multiple studies from our department. Other measurements are not
expected to cause side effects. Subjects will have a time investment of ±11.5
hours (screening, four test days, 24hr bp e.g.). A similar dose of AME has
already been used in previous studies, with no side effects.
Universiteitsingel 50
Maastricht 6229ER
NL
Universiteitsingel 50
Maastricht 6229ER
NL
Listed location countries
Age
Inclusion criteria
men and women, age 55-75, BMI 25-35 kg/m2
Exclusion criteria
smoking, diabetes mellitus, active cardiovascular disease, severe medical
conditions, use of supplements or medication affecting main outcomes,
contra-indications for MRI
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 |
|---|---|
| CCMO | NL80072.068.21 |