NCT04790188

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 10, 2021

Completed
22 days until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2022

Completed
Last Updated

May 18, 2022

Status Verified

May 1, 2022

Enrollment Period

6 months

First QC Date

March 3, 2021

Last Update Submit

May 17, 2022

Conditions

Cognitive Change

Outcome Measures

Primary Outcomes (1)

  • Simple and multiple reaction time

    Vienna Test System®

    1.5 hours

Secondary Outcomes (9)

  • Inhibitory control

    1.5 hours

  • Working Memory

    1.5 hours

  • Working memory

    1.5 hours

  • Creative Intelligence

    1.5 hours

  • Verbal fluidity

    1.5 hours

  • +4 more secondary outcomes

Study Arms (2)

Experimental intervention first.

EXPERIMENTAL

Participants randomized to receive the nootropic first.

Dietary Supplement: NootropicDietary Supplement: Placebo

Experimental intervention second.

PLACEBO COMPARATOR

Participants randomized to receive the placebo first

Dietary Supplement: NootropicDietary Supplement: Placebo

Interventions

NootropicDIETARY_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.

Experimental intervention first.Experimental intervention second.
PlaceboDIETARY_SUPPLEMENT

10g of maltodextrin lemon flavor (HSN®).

Experimental intervention first.Experimental intervention second.

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • To talk and to read Spanish fluently.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jonatan Ruiz Ruiz

Granada, 18011, Spain

Location

Related Publications (1)

  • 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.

    PMID: 35634417DERIVED

MeSH Terms

Interventions

Nootropic Agents

Intervention Hierarchy (Ancestors)

Central Nervous System AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

March 3, 2021

First Posted

March 10, 2021

Study Start

April 1, 2021

Primary Completion

September 25, 2021

Study Completion

May 15, 2022

Last Updated

May 18, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)