Clinical trial NCT02857829: The Effects of a Combination of Nootropic Ingredients on Cognition in Healthy Young Volunteers
Official title: The Effects of a Combination of Nootropic Ingredients on Cognition in Healthy Young Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Biomedical Enhancement
Keywords: Cognition
working memory
nootropic
reaction time
healthy individuals
cognitive enhancement
Lead sponsor: Nootrobox, Inc.
Sponsor class: INDUSTRY
First posted: 2016-08-05
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* BMI between 18.5-30
* Willing to sign informed consent

Exclusion Criteria:

* Suffer from or have a history of cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal, haematological or psychiatric illness (Also those volunteers who have a first-degree relative with a psychiatric disorder or a history with a psychiatric disorder will be excluded)
* Alcohol consumption \>20 drinks/week
* pregnant or lactating
* use of medication of than oral contraceptives
* use of recreation drugs 2 weeks before until the end of the experiment
* any motor or sensory deficits which could reasonably be expected to affect test performance

Primary outcomes:
measure: Verbal Memory: Immediate recall score
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Verbal Memory: Delayed recall score
timeFrame: Up to 12 weeks
measure: Working memory
timeFrame: Up to 12 weeks
measure: Response inhibition and focused attention
timeFrame: Up to 12 weeks
measure: Complex-scanning and visual tracking
timeFrame: Up to 12 weeks
measure: Simple and -choice reaction time
timeFrame: Up to 12 weeks
Other outcomes:
measure: Heart Rate
timeFrame: Up to 12 weeks
measure: Blood Pressure
timeFrame: Up to 12 weeks
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
Study officials:
affiliation: Maastricht University
name: Arjan Blokland, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University
name: Anke Sambeth, PhD
role: PRINCIPAL_INVESTIGATOR
References: