Effect of a Nootropic on the Cognitive Performance in Young Adults
NCT ID: NCT04790188
Last Updated: 2022-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
25 participants
INTERVENTIONAL
2021-04-01
2022-05-15
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
QUADRUPLE
Study Groups
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Experimental intervention first.
Participants randomized to receive the nootropic first.
Nootropic
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.
Placebo
10g of maltodextrin lemon flavor (HSN®).
Experimental intervention second.
Participants randomized to receive the placebo first
Nootropic
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.
Placebo
10g of maltodextrin lemon flavor (HSN®).
Interventions
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Nootropic
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.
Placebo
10g of maltodextrin lemon flavor (HSN®).
Eligibility Criteria
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Inclusion Criteria
* Ages 18-30 years
* BMI: 18-30.0 kg/m2
* Stable weight over the last 3 months (body weight changes\<3kg)
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.
18 Years
35 Years
ALL
Yes
Sponsors
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Universidad de Granada
OTHER
Responsible Party
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Jonatan Ruiz Ruiz
Associate professor
Locations
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Jonatan Ruiz Ruiz
Granada, , Spain
Countries
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References
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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.
Other Identifiers
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NOCOPE project
Identifier Type: -
Identifier Source: org_study_id
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