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Completed

NCT Number: NCT04790188

Effect of a Nootropic on the Cognitive Performance in Young Adults

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).

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Key information

Conditions

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jonatan Ruiz Ruiz

Granada, 18011, Spain

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Placebo

Dietary Supplement

10g of maltodextrin lemon flavor (HSN®).

Primary outcomes

  1. Simple and multiple reaction time

    Time frame: 1.5 hours

    Vienna Test System®

Secondary outcomes

  1. Inhibitory control

    Time frame: 1.5 hours

    Stroop test, E-Prime® software

  2. Working Memory

    Time frame: 1.5 hours

    Tests Flankers and Task switching, EPrime ® software

  3. Working memory

    Time frame: 1.5 hours

    N-Back y Spatial working memory , EPrime ® software

  4. Creative Intelligence

    Time frame: 1.5 hours

    CREA test

  5. Verbal fluidity

    Time frame: 1.5 hours

    Phonological and semantic verbal fluidity

  6. Motivation

    Time frame: 1.5 hours

    Situational Motivation Scale (EMSI)

  7. Mood

    Time frame: 1.5 hours

    EVEA scale

  8. Positive and negative emotions

    Time frame: 1.5 hours

    PANAS scale

  9. Adverse effects

    Time frame: 1.5 hours

    Visual analogue scales of adverse effects (gastrointestinal, nervous or psychologic)

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Mar 10, 2021
Registry last updated
May 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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