Effect of a Nootropic on the Cognitive Performance in Young Adults

Cognitive Change Clinical Trial

Official title:

Effect of a Nootropic on the Cognitive Performance in Young Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04790188
• Other study ID #: NOCOPE project
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: May 15, 2022

Study information

• Verified date: May 2022
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 15, 2022
• Est. primary completion date: September 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Change

Intervention

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.
• Placebo
10g of maltodextrin lemon flavor (HSN®).

Locations

Country	Name	City	State
Spain	Jonatan Ruiz Ruiz	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

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