Clinical trial NCT04790188: Effect of a Nootropic on the Cognitive Performance in Young Adults
Official title: Effect of a Nootropic on the Cognitive Performance in Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Change
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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

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.

Primary outcomes:
measure: Simple and multiple reaction time
timeFrame: 1.5 hours
Secondary outcomes:
measure: Inhibitory control
timeFrame: 1.5 hours
measure: Working Memory
timeFrame: 1.5 hours
measure: Working memory
timeFrame: 1.5 hours
measure: Creative Intelligence
timeFrame: 1.5 hours
measure: Verbal fluidity
timeFrame: 1.5 hours
measure: Motivation
timeFrame: 1.5 hours
measure: Mood
timeFrame: 1.5 hours
measure: Positive and negative emotions
timeFrame: 1.5 hours
measure: Adverse effects
timeFrame: 1.5 hours
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Jonatan Ruiz Ruiz
Study officials:
References:
citation: 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.