Cognitive ChangeNCT04790188
Effect of a Nootropic on the Cognitive Performance in Young Adults
A study testing Nootropic in people with Cognitive Change, run by Universidad de Granada at 1 site in Spain.
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). Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change
- What is being tested?
- Nootropic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2021to 15 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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
- Cognitive Change
- Being tested
- Nootropic, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboDietary supplement
10g of maltodextrin lemon flavor (HSN®).
| Study group | Role | What they receive |
|---|---|---|
| Experimental intervention first. | Experimental | Participants randomized to receive the nootropic first. Receives: Dietary Supplement: Nootropic; Dietary Supplement: Placebo |
| Experimental intervention second. | Placebo comparator | Participants randomized to receive the placebo first Receives: Dietary Supplement: Nootropic; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Simple and multiple reaction time
Vienna Test System®
Measured: 1.5 hours
Secondary outcomes (9)
Inhibitory control
Stroop test, E-Prime® software
Measured: 1.5 hours
Working Memory
Tests Flankers and Task switching, EPrime ® software
Measured: 1.5 hours
Working memory
N-Back y Spatial working memory , EPrime ® software
Measured: 1.5 hours
Creative Intelligence
CREA test
Measured: 1.5 hours
Verbal fluidity
Phonological and semantic verbal fluidity
Measured: 1.5 hours
Motivation
Situational Motivation Scale (EMSI)
Measured: 1.5 hours
Mood
EVEA scale
Measured: 1.5 hours
Positive and negative emotions
PANAS scale
Measured: 1.5 hours
Adverse effects
Visual analogue scales of adverse effects (gastrointestinal, nervous or psychologic)
Measured: 1.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start1 Apr 2021
- Primary completion25 Sep 2021
- Study completion15 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive ChangeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonatan Ruiz Ruiz, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04790188
- Sponsor's protocol ID
- NOCOPE project
- Status last verified
- May 2022
- First submitted
- 3 Mar 2021
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35634417
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Nootropic on the Cognitive Performance in Young Adults
- ClinicalTrials.gov ID
- NCT04790188
- Acronym / sponsor ID
- NOCOPE project
- Conditions
- Cognitive Change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 25 Sep 2021 (actual)
- Study completion
- 15 May 2022 (actual)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental intervention first. | Experimental | Dietary Supplement: Nootropic, Dietary Supplement: PlaceboParticipants randomized to receive the nootropic first. |
| Experimental intervention second. | Placebo comparator | Dietary Supplement: Nootropic, Dietary Supplement: PlaceboParticipants randomized to receive the placebo first |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nootropic10g 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 | Experimental intervention first., Experimental intervention second. |
| Placebo10g of maltodextrin lemon flavor (HSN®). | Dietary supplement | Experimental intervention first., Experimental intervention second. |
Primary outcome
Simple and multiple reaction time
Time frame: 1.5 hours
Vienna Test System®
9 secondary outcomes
Inhibitory control
Time frame: 1.5 hours
Working Memory
Time frame: 1.5 hours
Working memory
Time frame: 1.5 hours
Creative Intelligence
Time frame: 1.5 hours
Verbal fluidity
Time frame: 1.5 hours
Motivation
Time frame: 1.5 hours
Mood
Time frame: 1.5 hours
Positive and negative emotions
Time frame: 1.5 hours
Adverse effects
Time frame: 1.5 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Derived from this study: PubMed 35634417Medrano 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nootropic in people with Cognitive Change, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Simple and multiple reaction time (time frame: 1.5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04790188, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.