The Effects of a Combination of Nootropic Ingredients on Cognition in Healthy Young Volunteers
Condition: Biomedical Enhancement
Study type: Interventional

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.
    

Intervention name(s): CAF+; Caffeine-alone; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): CAF+ will be a blend consisting of caffeine (100 mg), L-theanine (200 mg), vinpocetine (40 mg), L-tyrosine (300 mg), pyridoxine (1 mg), and cobalamin (20 mg).; Caffeine (100 mg); Rice flour
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Cognition; working memory; nootropic; reaction time; healthy individuals; cognitive enhancement