History of Changes for Study: NCT04790188

Effect of a Nootropic on the Cognitive Performance in Young Adults

A study version is represented by a row in the table.
Select two study versions to compare. One each from columns A and B.
Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
Click "Compare" to do the comparison and show the differences.
Select a version's Submitted Date link to see a rendering of the study for that version.
The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
Hover over the "Recruitment Status" to see how the study's recruitment status changed.
Study edits or deletions are displayed in red.
Study additions are displayed in green.

Study Record Versions

Version	Submitted Date	Changes
1	March 8, 2021	None (earliest Version on record)
2	March 9, 2021	Oversight and Study Status
3	December 24, 2021	Recruitment Status, Study Status, Contacts/Locations and Study Design
4	May 17, 2022	Recruitment Status and Study Status

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	NOCOPE project
Brief Title:	Effect of a Nootropic on the Cognitive Performance in Young Adults
Official Title:	Effect of a Nootropic on the Cognitive Performance in Young Adults
Secondary IDs:

Study Status


Record Verification:	March 2021
Overall Status:	Not yet recruiting
Study Start:	April 1, 2021
Primary Completion:	April 2021 [Anticipated]
Study Completion:	September 2021 [Anticipated]

First Submitted:	March 3, 2021
First Submitted that Met QC Criteria:	March 8, 2021
First Posted:	March 10, 2021 [Actual]

Last Update Submitted that Met QC Criteria:	March 8, 2021
Last Update Posted:	March 10, 2021 [Actual]

Sponsor/Collaborators


Sponsor:	Universidad de Granada
Responsible Party:	Principal Investigator Investigator: Jonatan Ruiz Ruiz Official Title: Associate professor Affiliation: Universidad de Granada
Collaborators:

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	No
Data Monitoring:	No

Study Description

Brief 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).

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


Conditions:	Cognitive Change
Keywords:

Study Design


Study Type:	Interventional
Primary Purpose:	Other
Study Phase:	Not Applicable
Interventional Study Model:	Crossover Assignment
Number of Arms:	2
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:	Randomized
Enrollment:	25 [Anticipated]

Arms and Interventions

Arms

Assigned Interventions

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

Dietary Supplement: Placebo

10g of maltodextrin lemon flavor (HSN®).

Outcome Measures


Primary Outcome Measures:
1.	Simple and multiple reaction time [ Time Frame: 1.5 hours ] Vienna Test System®
Secondary Outcome Measures:
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)

Eligibility


Minimum Age:	18 Years
Maximum Age:	35 Years
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	Yes
Criteria:	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.

Contacts/Locations


Central Contact Person:	Lucas Jurado-Fasoli, PhD student Telephone: 618375662 Ext. 34 Email: juradofasoli@ugr.es
Central Contact Backup:	Jonatan R. Ruiz, PhD Email: ruizj@ugr.es
Locations:

IPDSharing


Plan to Share IPD:	No

References


Links:
Available IPD/Information: