CompletedNCT04790188Updated May 18, 2022

Effect of a Nootropic on the Cognitive Performance in Young Adults

An interventional study of Nootropic and Placebo in Cognitive Change, sponsored by Universidad de Granada. Completed at 1 site in Spain. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-18.

Sponsored by Universidad de Granada · Not applicable, Interventional, and Other

Phase: Not applicable
Study type: Interventional
Enrollment: 25
Allocation: Randomized
Ages: 18 Years to 35 Years
Sex: All

Study 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).

Read the 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

Conditions studied

Cognitive Change

In context

Lead sponsor

Universidad de Granada is the lead sponsor of 241 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 35 Years
Sexes eligible: All
Accepts 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.

Exclusion criteria

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.

Study design

Phase: Not applicable
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 25 participants (actual)

Study arms

Experimental
Experimental intervention first.
Participants randomized to receive the nootropic first.
Dietary Supplement: Nootropic · Dietary Supplement: Placebo
Placebo comparator
Experimental intervention second.
Participants randomized to receive the placebo first
Dietary Supplement: Nootropic · Dietary Supplement: Placebo

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®).

What researchers measure

Primary outcomes

Simple and multiple reaction time
Vienna Test System®
Time frame: 1.5 hours

Secondary outcomes

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

Study locations

1 site

Jonatan Ruiz Ruiz
Granada, 18011, Spain

References and documents

Publications

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. PubMed 35634417 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04790188
Lead sponsor: Universidad de Granada
Responsible party: Jonatan Ruiz Ruiz (Associate professor, Universidad de Granada) — Principal investigator
First posted: Mar 10, 2021
Start date: Apr 1, 2021
Primary completion: Sep 25, 2021
Completion: May 15, 2022
Last update: May 18, 2022

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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