Effect of a Nootropic on the Cognitive Performance in Young Adults

• ClinicalTrials.gov Identifier: NCT04790188
• Recruitment Status: Completed
• First Posted: March 10, 2021
• Last Update Posted: May 18, 2022
• Sponsor: Universidad de Granada
• Information provided by (Responsible Party): Jonatan Ruiz Ruiz, Universidad de Granada

Tracking Information

• First Submitted Date: March 3, 2021
• First Posted Date: March 10, 2021
• Last Update Posted Date: May 18, 2022
• Actual Study Start Date: April 1, 2021
• Actual Primary Completion Date: September 25, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 8, 2021)

Simple and multiple reaction time [ Time Frame: 1.5 hours ]

Vienna Test System®

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 8, 2021)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Other
• Condition: 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.
• Dietary Supplement: Placebo
  10g of maltodextrin lemon flavor (HSN®).

Study Arms

• Experimental: Experimental intervention first.
  Participants randomized to receive the nootropic first.
  Interventions:

  • Dietary Supplement: Nootropic
  • Dietary Supplement: Placebo
• Placebo Comparator: Experimental intervention second.
  Participants randomized to receive the placebo first
  Interventions:

  • Dietary Supplement: Nootropic
  • Dietary Supplement: Placebo

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 8, 2021): 25
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: May 15, 2022
• Actual Primary Completion Date: September 25, 2021 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 35 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT04790188
• Other Study ID Numbers: NOCOPE project
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Jonatan Ruiz Ruiz, Universidad de Granada
• Original Responsible Party: Same as current
• Current Study Sponsor: Universidad de Granada
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Universidad de Granada
• Verification Date: May 2022