Biomedical Enhancement Clinical Trial
Official title:
The Effects of a Combination of Nootropic Ingredients on Cognition in Healthy Young Volunteers
Achieving optimal concentration during cognitively demanding tasks is of immense human value. Despite our understanding of the important role that attention, working memory, and fluid intelligence play in professional success, and the huge individual differences in these constructs, the modulation of these cognitive domains has not been rigorously studied. From the widespread use of caffeine, to the more questionable and increasing use of prescription medications to achieve peak attention, the tremendous interest in achieving cognitive performance has driven individuals to experiment, often with prescription and illegal drugs. Herein, we aim to standardize and extend the study of attention modulating substances, to identify blends that achieve safe enhancements in attention and working memory. Specific to this proposal, we aim to develop CAF+, a blend of natural and generally regarded as safe compounds to improve attention and working memory in normal, healthy individuals. CAF+ is composed of caffeine (100 mg), L-theanine (200 mg), vinpocetine (40 mg), L-tyrosine (300 mg), pyridoxine (0.06 mg), and cobalamin (20 mg).
Rationale: There is still a great need to find treatments that can improve cognitive function
in people that suffer from memory and attention problems, as well as healthy, young
individuals. There are various natural ingredients that have been claimed to improve
cognitive functions in humans (e.g., caffeine, L-theanine, vinpocetine). These ingredients
have a different mechanism of action and are assumed to have a general effect on brain
function. It is hypothesized that a combination of these natural ingredients may be more
effective to improve cognitive performance. In this study we would like to test the
cognition-enhancing potential of a mixture of different natural ingredients.
Objective: Examine the effects of a treatment that consists of different natural ingredients
on cognitive performance in young healthy subjects. These effects will be compared with
caffeine treatment, a natural ingredient that has been found to improve cognition in various
studies.
Study design: This study will use a double-blind placebo controlled, cross-over design.
Study population: Twenty-one healthy subjects in the age range from 18-35 years will be
included.
Intervention: The subjects will be tested three times. At each test session they will receive
one capsule (Placebo, Caffeine, or CAF+).
Main study parameters/endpoints: The primary outcome measure is the number of recalled words
in a verbal word learning task.
Nature and extent of the burden and risks associated with participation, benefit and group
relatedness: The subjects who will be included in the study will visit the testing site four
times (medical screening + practice session, and three test sessions). Each testing session
will last 2.5 h. In total the subjects will spent about 10 h when they participate. During
the three test sessions the subjects will receive a capsule that contains a placebo, caffeine
or a combination of different natural ingredients. These treatments are well tolerated. No
adverse reactions of treatment are expected. The subjects have to abstain from drinking
coffee and smoking the evening before the test days. The results of this study will reveal
whether a combination of different natural ingredients is more effective than coffee to
improve cognitive functions. In the light of a great demand for finding treatments that can
be beneficial for old subjects suffering from age-related cognitive impairments, it is
considered that the risks are minimal and there is a considerable potential benefit.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT05550987 -
The Use of Modern Technologies in Neurorehabilitation
|
N/A |