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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).
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental intervention first. | Experimental | Participants randomized to receive the nootropic first. |
|
| Experimental intervention second. | Placebo Comparator | Participants randomized to receive the placebo first |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nootropic | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Simple and multiple reaction time | Vienna Test System® | 1.5 hours |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jonatan Ruiz Ruiz | Granada | 18011 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35634417 | Derived | Medrano M, Molina-Hidalgo C, Alcantara JMA, Ruiz JR, Jurado-Fasoli L. Acute Effect of a Dietary Multi-Ingredient Nootropic as a Cognitive Enhancer in Young Healthy Adults: A Randomized, Triple-Blinded, Placebo-Controlled, Crossover Trial. Front Nutr. 2022 May 12;9:858910. doi: 10.3389/fnut.2022.858910. eCollection 2022. |
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| ID | Term |
|---|---|
| D018697 | Nootropic Agents |
| ID | Term |
|---|---|
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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|
| Placebo | Dietary Supplement | 10g of maltodextrin lemon flavor (HSN®). |
|
| 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 |