Effect of a Nootropic on the Cognitive Performance in Young Adults

Study Overview
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Brief Summary
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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
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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

Official Title
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Effect of a Nootropic on the Cognitive Performance in Young Adults

Conditions
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Cognitive Change

Intervention / Treatment
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* Dietary Supplement: Nootropic
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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. Exclusion Criteria: History of neurological disease or mental disease. History of cardiovascular disease Diabetes or hypertension Pregnant, planning to become pregnant, or breastfeeding Have been treated previously or during the study period with neurological drugs. Have been treated previously or during the study period with prescription drugs: antihypertensive, lipid lowering, acid uric lowering, glucose lowering, beta blockers or any drug that under the investigator's judged could influence the results. Allergy/intolerance to any ingredient of the nootropic. High caffeine consumes (>300mg/day, or >3 coffees/day). Any non-controlled medical condition which could influence results or could be worsened by the participation in the study. Are deemed unsuitable by the investigator for any other reason, that prevent data collection.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental intervention first.<br>Participants randomized to receive the nootropic first. | Dietary Supplement: Nootropic<br>* 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.<br>Dietary Supplement: Placebo<br>* 10g of maltodextrin lemon flavor (HSN®).<br>|
| Placebo Comparator: Experimental intervention second.<br>Participants randomized to receive the placebo first | Dietary Supplement: Nootropic<br>* 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.<br>Dietary Supplement: Placebo<br>* 10g of maltodextrin lemon flavor (HSN®).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Simple and multiple reaction time | Vienna Test System® | 1.5 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inhibitory control | Stroop test, E-Prime® software | 1.5 hours | 
| Working Memory | Tests Flankers and Task switching, EPrime ® software | 1.5 hours | 
| Working memory | N-Back y Spatial working memory , EPrime ® software | 1.5 hours | 
| Creative Intelligence | CREA test | 1.5 hours | 
| Verbal fluidity | Phonological and semantic verbal fluidity | 1.5 hours | 
| Motivation | Situational Motivation Scale (EMSI) | 1.5 hours | 
| Mood | EVEA scale | 1.5 hours | 
| Positive and negative emotions | PANAS scale | 1.5 hours | 
| Adverse effects | Visual analogue scales of adverse effects (gastrointestinal, nervous or psychologic) | 1.5 hours |