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).

Study Overview

• Status: Completed
• Conditions: Cognitive Change
• Intervention / Treatment: Dietary supplement: Nootropic; Dietary supplement: Placebo

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

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Granada, Spain, 18011
    • Jonatan Ruiz Ruiz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental intervention first.; Participants randomized to receive the nootropic first.	Dietary supplement: 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.; Dietary supplement: Placebo; 10g of maltodextrin lemon flavor (HSN®).
PLACEBO_COMPARATOR: Experimental intervention second.; Participants randomized to receive the placebo first	Dietary supplement: 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.; Dietary supplement: Placebo; 10g of maltodextrin lemon flavor (HSN®).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universidad de Granada

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2021
• Primary Completion (ACTUAL): September 25, 2021
• Study Completion (ACTUAL): May 15, 2022

Study Registration Dates

• First Submitted: March 3, 2021
• First Submitted That Met QC Criteria: March 8, 2021
• First Posted (ACTUAL): March 10, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 18, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nootropic Agents
• Other Study ID Numbers: NOCOPE project

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No