Cognitive Change
Conditions
Brief summary
The main aim of this study is to determine the effect of a nootropic on cognitive performance (i.e., reaction time, inhibitory control, cognitive flexibility, working memory, neuro-psychological outcomes).
Detailed description
Cognitive decline is a worrisome consequence of normal or pathologic ageing, having a high personal, eco- nomic and societal burden; also, it could herald the onset of dementia which is associated with significant morbidity and mortality. However, with a general increase in life expectancy and a corresponding increase in the prevalence of age-related cognitive impairment, there have been concerted efforts towards the development and adoption of preventive strategies that would minimize the risk of developing dementia, or reduce the rate of cognitive decline with ageing. In the last few decades, certain compounds have been found useful in the management of cognitive decline. The term 'nootropic' has been used to define such substances with the capacity to enhance cognition. While research has led to the synthesis of several drugs with nootropic effects, attention is now being shifted to the discovery, characterization and utilization of nootropics from natural sources for the prevention and management of age-related cognitive decline. 25 young adults will be randomized into two conditions (nootropic and placebo conditions) with 48 hours of separation between conditions. 48h previous to the randomization the participants will perform a familiarization to avoid the learning effects. Each evaluation day will conform to the following tests: * Simple and multiple reaction time * Inhibitory control * Cognitive flexibility * Working memory * Creative intelligence * Verbal fluidity * Motivation * Mood * Positive and negative emotions * Adverse effects
Interventions
DIETARY_SUPPLEMENTNootropic
10g of Evo-Gamers® lemon flavor (HSN®). The nutritional composition per service is: L-Tyrosine (1000mg), Acetyl L-Carnitine HCL (500mg), Citicoline sodium (200mg), L-alpha-Glycerylphosphorylcholine (Alpha-GPC; 100mg), Vitamin C (150mg), Vitamin E (12.1mg), Vitamin B6 (3mg), Vitamin B2 (3mg), Vitamin A (810μg), Vitamin D (10μg), Vitamin B12 (5μg), Taurine (500mg), Caffeine (300mg), L-Theanine (150mg), Mango Leaves (2000mg), Huperzia Leaves (200mg). The dose to be administered is that recommended on the labeling and nutritional information of the nootropic which has been produced under GMP procedures and approved by the EFSA.
DIETARY_SUPPLEMENTPlacebo
10g of maltodextrin lemon flavor (HSN®).
Sponsors
Universidad de Granada
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male or female * Ages 18-30 years * BMI: 18-30.0 kg/m2 * Stable weight over the last 3 months (body weight changes\<3kg) * Participant must be capable and willing to provide consent, understand
Exclusion criteria
, instructions and protocols. * To talk and to read Spanish fluently.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Simple and multiple reaction time | 1.5 hours | Vienna Test System® |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Working Memory | 1.5 hours | Tests Flankers and Task switching, EPrime ® software |
| Working memory | 1.5 hours | N-Back y Spatial working memory , EPrime ® software |
| Creative Intelligence | 1.5 hours | CREA test |
| Verbal fluidity | 1.5 hours | Phonological and semantic verbal fluidity |
| Inhibitory control | 1.5 hours | Stroop test, E-Prime® software |
| Mood | 1.5 hours | EVEA scale |
| Positive and negative emotions | 1.5 hours | PANAS scale |
| Adverse effects | 1.5 hours | Visual analogue scales of adverse effects (gastrointestinal, nervous or psychologic) |
| Motivation | 1.5 hours | Situational Motivation Scale (EMSI) |
Countries
Spain
Outcome results
None listed