To examine the effects of a treatment that consists of different natural ingredients on cognitive performance in two different age groups. These effects will be compared with placebo treatment.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
geen aandoening
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is the number of recalled words in a verbal word lea
rning task, and the score on a spatial memory task which measures how
efficiently subjects can separate a representation of a picture from a similar,
but different, picture.
Secondary outcome
The following secundary measures will be examined in this study:
* The number of words memorized long-term in a verbal learning task.
* The number of correct responses in a working memory task.
* The performance on the Digit symbol substitution task to assess complex scanni
ng.
* The speed of responding in combination with correct responses in a psychomotor
task.
*The performance on a trail making test which measures mental flexibility and
attention.
* The performance on the Stroop to measure attention and inhibition.
* EEG measurement during the above mentioned behavioral tasks and during a
sensory gating task, which look at the efficiency of the brain in filtering out
unnecessary information.
Background summary
There is still a great need to find treatments that can improve cognitive functi
on in people that suffer from memory and
attention problems. There are various natural ingredients that have been claimed
to improve cognitive functions in humans, such as PDE 4-inhibitors. In this
study, a PDE 4-inhibitor will be combined with an ingredient that can enhance
this PDE 4-inhibition, together with other natural ingredients which have
potential to improve cognition as well.
It is hypothesized that this combination of these natural ingredients may
be more effective to improve cognitive performance that PDE 4-inhibition
alone.
Study objective
To
examine the effects of a treatment that consists of different natural ingredient
s on cognitive performance in two different age
groups. These effects will be compared with placebo treatment.
Study design
This study will use a double blind placebo controlled crossover design.
Intervention
Participants will be tested two times. During each test session, they will
receive one capsule (CILTEP or placebo).
Study burden and risks
The subjects who will be included in the study will visit the testing site
three to four times (medical screening + practice session including memory
screening, and two test sessions). Each testing session will last 2.5 h and the
medical screening, training and memory screening maximum 3
h. In total the subjects will spend about 8 h when they
participate. During the two test sessions the subjects will receive a capsule th
at contains a placebo, or a
combination of different natural ingredients. These treatments are well tolerate
d. No adverse reactions of treatment are
expected. The subjects have to abstain from drinking coffee and alcohol. Two
blood samples will be taken on each test day.
Universiteitssingel 40
Maastricht 6229ER
NL
Universiteitssingel 40
Maastricht 6229ER
NL
Listed location countries
Age
Inclusion criteria
30-40 or 60-75 years of age
Healthy
Normal static binocular acuity (corrected or uncorrected)
Body mass index between 18.5-30
Score op de Woord-Leertaak die binnen 1 standaarddeviatie van het gemiddelde valt
Willingness to sign informed consent
Exclusion criteria
having a history of cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal, haematological or psychiatric illness, having a first-degree relative with a psychiatric disorder or a history with a psychiatric disorder, excessive drinking (>20 glasses of alcohol containing beverages a week), pregnancy or lactation, use of psychoactive medication, centrally acting beta blockers, use of recreational drugs from 2 weeks before until the end of the experiment, systolic blood pressure above 160 mmHg, phenylketonuria, any sensory or motor deficits which could reasonably be expected to affect test performance, and use of steroids or Sudafed (pseudoephedrine).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL60999.068.17 |
| OMON | NL-OMON21957 |