Cognitive PerformanceNCT07166835
Exploring the Cognitive Benefits of a Blackcurrant-Based Supplement in Normobaric Hypoxia
A study testing Nootropics (ginkgo biloba, nicergoline, piracetam, or others) in people with Cognitive Performance and Executive Function (Cognition), run by Leeds Beckett University at 1 site in United Kingdom.
Trial summary
This study investigates the cognitive effects of Ārepa, a blackcurrant-based drink, under simulated high-altitude conditions (4,500m normobaric hypoxia for ~180 minutes). Using a double-blind, randomised, placebo-controlled crossover design, participants will consume either the nootropic blackcurrant-based drink or a… Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cognitive Performance, Executive Function (Cognition), Working Memory
- What is being tested?
- Nootropics (ginkgo biloba, nicergoline, piracetam, or others)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2025to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willing and able to provide written informed consent (in English)
- Aged 18-35
- Male
- Residing at a low altitude (<500m)
Who cannot join
- Diagnosed food allergy or intolerance to the investigational products or control products. (Blackcurrant, food allergen/ pine, tree-derived allergen/ l-theanine tree allergen (camellia sinensis))
- Significant past medical and psychiatric history and ongoing chronic conditions such as, cardiovascular disease, respiratory disease, endocrine disorder (e.g. Diabetes mellites) and neurological and psychiatric conditions including brain injury or are colourblind.
- Significant medication history or current prescription of medication or supplements known to affect cognition such as. Sedatives, stimulants, or herbal supplements high in anthocyanin and polyphenol content.
- A positive result from the pre-screening sickle cell trait blood test.
- An abnormal ECG reading.
- A resting heart rate above 100bmp.
Show all 10Show fewer
- A blood pressure reading above 140/90mmHg.
- Subjects not willing and/ or not able to comply with the scheduled visits required for the study.
- Not willing to provide blood samples.
- Not classified as low risk based on the ACSM guidelines.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Leeds Beckett University
Leeds, LS6 3QS
Isobel R Harris, +44 7443518358, i.harris@leedsbeckett.ac.uk
About this study
Official title: The Efficacy of a Blackcurrant-based Nootropic Drink to Support Cognitive Functioning Under Normobaric Simulated High Altitude
This study investigates the cognitive effects of Ārepa, a blackcurrant-based drink, under simulated high-altitude conditions (4,500m normobaric hypoxia for ~180 minutes). Using a double-blind, randomised, placebo-controlled crossover design, participants will consume either the nootropic blackcurrant-based drink or a taste-matched placebo. Cognitive testing (~80 minutes) includes Trail-making, Stroop, N-back, Serial 7s/3s, and RVIP tasks. Physiological measures (heart rate, SpO₂, blood) and biomarkers (MAO-B, BDNF, hsCRP, S100B, Prolactin, C3G, Sarmentosin) will be assessed. Scales will evaluate mood, wellbeing, and perceived effects. The aim is to determine if the nootropic drink can support cognitive function in hypoxic environments.
Read the detailed description
Cognitive functioning can be influenced by varying factors including age, education, fatigue and environmental conditions. It is well established that stress, including hypoxia, sleep deprivation, and mental fatigue, alters brain energetics therefore resulting in a decline of cognitive function. Any physical or psychological stressor that disrupts homeostasis results in a stress response. Altitude, often associated with sports, recreational activities and holidaying, refers to environments where the partial pressure of oxygen (pO2) is reduced relative to sea level. The effects of high altitude on humans are mostly the consequences of reduced pO2 in the atmosphere and can result in fatigue, dizziness and debilitating cognitive consequences to unacclimatised individuals. These effects can significantly impair cognitive and physical performance at high elevations. In this context, interests in prophylactic use of dietary interventions to mitigate the effects of oxygen deprivation has increased in recent years. Interventions utilising a number of plant derived phytochemicals have demonstrated some protective efficacy against these physiological insults and may be capable of attenuating cognitive function and mood under hypoxic stress. However, there is limited research available on polyphenol supplementation to support cognition at high altitudes. Therefore, the purpose of the study is to explore the possibility of the nootropic drink and how effective it is in reducing cognitive impairment of healthy males at a simulated high altitude of 4,500m.
Participants will attend the laboratory on four occasions over a 2-3-week period. The first two visits will involve a pre-screening assessment and a familiarisation session with the experimental procedures and cognitive tasks.
The subsequent two visits will serve as the experimental trials, during which participants will be exposed to a normobaric hypoxic environment simulating an altitude of 4,500 meters. This condition is achieved by maintaining sea-level barometric pressure with a reduced inspired oxygen fraction (FiO₂ ~11.3%, equivalent to a PiO₂ of approximately 80.9 mmHg).
Acute exposure to high altitudes (3,000-4,500 m) for durations as short as 45 to 120 minutes has been shown to impair cognitive function, increase mood disturbances, reduce task accuracy, and slow reaction times. Based on prior research the duration of hypoxic exposure in this study will be approximately 180 minutes, allowing sufficient time for potential cognitive changes to occur.
Each experimental trial will follow a double-blind, randomised, placebo-controlled crossover design. Participants will consume 100 mL of either an anthocyanin-rich blackcurrant drink (containing 200 mg of bioactive compounds) or a taste- and appearance-matched placebo (0 mg). A 45-minute rest period will follow to allow for absorption.
Cognitive testing will span approximately 80 minutes and will begin 75 minutes into the hypoxic exposure. This includes three short tasks (approximately 10 minutes in total) administered before and after a 60-minute cognitive demand battery. The cognitive tasks will assess executive function, working memory, attention, and cognitive load.
Physiological measures (e.g., heart rate, SpO₂), blood-based biomarkers (e.g., MAO-B, BDNF, hsCRP, S100B, prolactin, C3G, sarmentosin), and self-reported scales assessing mood, anxiety, perceived cognitive workload, and subjective effects will also be collected throughout the trial.
- Conditions
- Cognitive Performance, Executive Function (Cognition), Working Memory, Hypoxia Induced Cognitive Impairment, Mood
- Being tested
- Nootropics (ginkgo biloba, nicergoline, piracetam, or others), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nootropics (ginkgo biloba, nicergoline, piracetam, or others)Dietary supplement
Nootropic drink containing Anthrocyanins, L-theanie and Enzogenol
PlaceboDietary supplement
Taste- and appearance-matched placebo beverage without active ingredients.
| Study group | Role | What they receive |
|---|---|---|
| Nootropic drink | Active comparator | Nootropic beverage containing anthocyanins, L-theanine, and Enzogenol. Administered orally prior to cognitive testing under simulated normobaric hypoxia. Receives: Dietary Supplement: Nootropics (ginkgo biloba, nicergoline, piracetam, or others) |
| Placebo drink | Placebo comparator | Taste- and appearance-matched placebo beverage without active ingredients. Administered orally prior to cognitive testing under simulated normobaric hypoxia. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Executive Function (Trail Making Task)
Change from baseline (sea level, pre-supplementation) in completion time during acute high-altitude exposure, assessed at ~1 hour and ~2 hours post exposure following a cognitive demand battery. Measures of correct response and reaction time in seconds.
Measured: Baseline (sea level, pre-supplementation), approximately 1 hour (±10 minutes) after exposure, and 2 hours (±10 minutes) after exposure.
Working Memory (N-back)
Change from baseline (sea level, pre-supplementation) in accuracy (percent correct responses) and mean reaction time (milliseconds) on the N-back task during acute high-altitude exposure, assessed at ~1 hour and ~2 hours post exposure following a cognitive demand battery. Measures are response time in milliseconds and percentage of correct response.
Measured: Baseline (sea level, pre-supplementation), approximately 1 hour (±10 minutes) after exposure, and 2 hours (±10 minutes) after exposure.
Attention (RVIP) as part of the Cognitive Demand Battery
Change from baseline (sea level, pre-supplementation) in accuracy (percent correct) and mean reaction time (milliseconds) on the RVIP task, administered as part of a repeated cognitive demand battery beginning ~1 hr 20 min into acute high-altitude exposure and repeated 6 times within 1 hour.
Measured: Baseline (sea level, pre-supplementation), and 6 repeated assessments during the cognitive demand battery conducted between 1 hr 20 min and 2 hr 20 min after onset of acute high-altitude exposure.
Executive Function (Stroop, colour word task)
Change from baseline (sea level, pre-supplementation) in number of correct responses and mean reaction time during acute high-altitude exposure, assessed at ~1 hour and ~2 hours post exposure following a cognitive demand battery. Measures are number of correct responses and response time in seconds.
Measured: Baseline (sea level, pre-supplementation), approximately 1 hour (±10 minutes) after exposure, and 2 hours (±10 minutes) after exposure.
Working Memory (Serial 7s)
Change from baseline (sea level, pre-supplementation) in number of correct subtractions on the Serial 7s task, administered as part of a repeated cognitive demand battery beginning ~1 hr 20 min into acute high-altitude exposure and repeated 6 times within 1 hour. Measure is Number of correct responses.
Measured: Baseline (sea level, pre-supplementation), and 6 repeated assessments during the cognitive demand battery conducted between 1 hr 20 min and 2 hr 20 min after onset of acute high-altitude exposure.
Working Memory (Serial 3s)
Change from baseline (sea level, pre-supplementation) in number of correct subtractions on the Serial 3s task, administered as part of a repeated cognitive demand battery beginning ~1 hr 20 min into acute high-altitude exposure and repeated 6 times within 1 hour. Units of measure is the number of correct responses.
Measured: Baseline (sea level, pre-supplementation), and 6 repeated assessments during the cognitive demand battery conducted between 1 hr 20 min and 2 hr 20 min after onset of acute high-altitude exposure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start1 Sep 2025 (estimated)
- Primary completion25 Dec 2025 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive PerformanceStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leeds Beckett University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07166835
- Sponsor's protocol ID
- 151421
- Status last verified
- Sep 2025
- First submitted
- 26 Aug 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of a Blackcurrant-based Nootropic Drink to Support Cognitive Functioning Under Normobaric Simulated High Altitude
- ClinicalTrials.gov ID
- NCT07166835
- Acronym / sponsor ID
- 151421
- Conditions
- Cognitive Performance, Executive Function (Cognition), Working Memory, Hypoxia Induced Cognitive Impairment, Mood
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Leeds Beckett UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 25 Dec 2025 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 10 Sep 2025 (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.
This study investigates the cognitive effects of Ārepa, a blackcurrant-based drink, under simulated high-altitude conditions (4,500m normobaric hypoxia for ~180 minutes). Using a double-blind, randomised, placebo-controlled crossover design, participants will consume either the nootropic blackcurrant-based drink or a taste-matched placebo. Cognitive testing (~80 minutes) includes Trail-making, Stroop, N-back, Serial 7s/3s, and RVIP tasks. Physiological measures (heart rate, SpO₂, blood) and biomarkers (MAO-B, BDNF, hsCRP, S100B, Prolactin, C3G, Sarmentosin) will be assessed. Scales will evaluate mood, wellbeing, and perceived effects. The aim is to determine if the nootropic drink can support cognitive function in hypoxic environments.
Detailed description
Cognitive functioning can be influenced by varying factors including age, education, fatigue and environmental conditions. It is well established that stress, including hypoxia, sleep deprivation, and mental fatigue, alters brain energetics therefore resulting in a decline of cognitive function. Any physical or psychological stressor that disrupts homeostasis results in a stress response. Altitude, often associated with sports, recreational activities and holidaying, refers to environments where the partial pressure of oxygen (pO2) is reduced relative to sea level. The effects of high altitude on humans are mostly the consequences of reduced pO2 in the atmosphere and can result in fatigue, dizziness and debilitating cognitive consequences to unacclimatised individuals. These effects can significantly impair cognitive and physical performance at high elevations. In this context, interests in prophylactic use of dietary interventions to mitigate the effects of oxygen deprivation has increased in recent years. Interventions utilising a number of plant derived phytochemicals have demonstrated some protective efficacy against these physiological insults and may be capable of attenuating cognitive function and mood under hypoxic stress. However, there is limited research available on polyphenol supplementation to support cognition at high altitudes. Therefore, the purpose of the study is to explore the possibility of the nootropic drink and how effective it is in reducing cognitive impairment of healthy males at a simulated high altitude of 4,500m.
Participants will attend the laboratory on four occasions over a 2-3-week period. The first two visits will involve a pre-screening assessment and a familiarisation session with the experimental procedures and cognitive tasks.
The subsequent two visits will serve as the experimental trials, during which participants will be exposed to a normobaric hypoxic environment simulating an altitude of 4,500 meters. This condition is achieved by maintaining sea-level barometric pressure with a reduced inspired oxygen fraction (FiO₂ ~11.3%, equivalent to a PiO₂ of approximately 80.9 mmHg).
Acute exposure to high altitudes (3,000-4,500 m) for durations as short as 45 to 120 minutes has been shown to impair cognitive function, increase mood disturbances, reduce task accuracy, and slow reaction times. Based on prior research the duration of hypoxic exposure in this study will be approximately 180 minutes, allowing sufficient time for potential cognitive changes to occur.
Each experimental trial will follow a double-blind, randomised, placebo-controlled crossover design. Participants will consume 100 mL of either an anthocyanin-rich blackcurrant drink (containing 200 mg of bioactive compounds) or a taste- and appearance-matched placebo (0 mg). A 45-minute rest period will follow to allow for absorption.
Cognitive testing will span approximately 80 minutes and will begin 75 minutes into the hypoxic exposure. This includes three short tasks (approximately 10 minutes in total) administered before and after a 60-minute cognitive demand battery. The cognitive tasks will assess executive function, working memory, attention, and cognitive load.
Physiological measures (e.g., heart rate, SpO₂), blood-based biomarkers (e.g., MAO-B, BDNF, hsCRP, S100B, prolactin, C3G, sarmentosin), and self-reported scales assessing mood, anxiety, perceived cognitive workload, and subjective effects will also be collected throughout the trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nootropic drink | Active comparator | Dietary Supplement: Nootropics (ginkgo biloba, nicergoline, piracetam, or others)Nootropic beverage containing anthocyanins, L-theanine, and Enzogenol. Administered orally prior to cognitive testing under simulated normobaric hypoxia. |
| Placebo drink | Placebo comparator | Dietary Supplement: PlaceboTaste- and appearance-matched placebo beverage without active ingredients. Administered orally prior to cognitive testing under simulated normobaric hypoxia. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Willing and able to provide written informed consent (in English)
- Aged 18-35
- Male
- Residing at a low altitude (<500m)
Key exclusion criteria (10 listed)
- Diagnosed food allergy or intolerance to the investigational products or control products. (Blackcurrant, food allergen/ pine, tree-derived allergen/ l-theanine tree allergen (camellia sinensis))
- Significant past medical and psychiatric history and ongoing chronic conditions such as, cardiovascular disease, respiratory disease, endocrine disorder (e.g. Diabetes mellites) and neurological and psychiatric conditions including brain injury or are colourblind.
- Significant medication history or current prescription of medication or supplements known to affect cognition such as. Sedatives, stimulants, or herbal supplements high in anthocyanin and polyphenol content.
- A positive result from the pre-screening sickle cell trait blood test.
- An abnormal ECG reading.
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 |
|---|---|---|
| Nootropics (ginkgo biloba, nicergoline, piracetam, or others)Nootropic drink containing Anthrocyanins, L-theanie and Enzogenol | Dietary supplement | Nootropic drink |
| PlaceboTaste- and appearance-matched placebo beverage without active ingredients. | Dietary supplement | Placebo drink |
Primary outcome
Executive Function (Trail Making Task)
Time frame: Baseline (sea level, pre-supplementation), approximately 1 hour (±10 minutes) after exposure, and 2 hours (±10 minutes) after exposure.
Change from baseline (sea level, pre-supplementation) in completion time during acute high-altitude exposure, assessed at ~1 hour and ~2 hours post exposure following a cognitive demand battery. Measures of correct response and reaction time in seconds.
Working Memory (N-back)
Time frame: Baseline (sea level, pre-supplementation), approximately 1 hour (±10 minutes) after exposure, and 2 hours (±10 minutes) after exposure.
Change from baseline (sea level, pre-supplementation) in accuracy (percent correct responses) and mean reaction time (milliseconds) on the N-back task during acute high-altitude exposure, assessed at ~1 hour and ~2 hours post exposure following a cognitive demand battery. Measures are response time in milliseconds and percentage of correct response.
Attention (RVIP) as part of the Cognitive Demand Battery
Time frame: Baseline (sea level, pre-supplementation), and 6 repeated assessments during the cognitive demand battery conducted between 1 hr 20 min and 2 hr 20 min after onset of acute high-altitude exposure.
Change from baseline (sea level, pre-supplementation) in accuracy (percent correct) and mean reaction time (milliseconds) on the RVIP task, administered as part of a repeated cognitive demand battery beginning ~1 hr 20 min into acute high-altitude exposure and repeated 6 times within 1 hour.
Executive Function (Stroop, colour word task)
Time frame: Baseline (sea level, pre-supplementation), approximately 1 hour (±10 minutes) after exposure, and 2 hours (±10 minutes) after exposure.
Change from baseline (sea level, pre-supplementation) in number of correct responses and mean reaction time during acute high-altitude exposure, assessed at ~1 hour and ~2 hours post exposure following a cognitive demand battery. Measures are number of correct responses and response time in seconds.
Working Memory (Serial 7s)
Time frame: Baseline (sea level, pre-supplementation), and 6 repeated assessments during the cognitive demand battery conducted between 1 hr 20 min and 2 hr 20 min after onset of acute high-altitude exposure.
Change from baseline (sea level, pre-supplementation) in number of correct subtractions on the Serial 7s task, administered as part of a repeated cognitive demand battery beginning ~1 hr 20 min into acute high-altitude exposure and repeated 6 times within 1 hour. Measure is Number of correct responses.
Working Memory (Serial 3s)
Time frame: Baseline (sea level, pre-supplementation), and 6 repeated assessments during the cognitive demand battery conducted between 1 hr 20 min and 2 hr 20 min after onset of acute high-altitude exposure.
Change from baseline (sea level, pre-supplementation) in number of correct subtractions on the Serial 3s task, administered as part of a repeated cognitive demand battery beginning ~1 hr 20 min into acute high-altitude exposure and repeated 6 times within 1 hour. Units of measure is the number of correct responses.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nootropics (ginkgo biloba, nicergoline, piracetam, or others) in people with Cognitive Performance and Executive Function (Cognition), run by Leeds Beckett University at 1 site in United Kingdom.
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 4 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: opening soon, as of the sponsor's last update on 10 Sep 2025. 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 United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isobel R Harris (+44 7443518358, i.harris@leedsbeckett.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Executive Function (Trail Making Task) (time frame: Baseline (sea level, pre-supplementation), approximately 1 hour (±10 minutes) after exposure, and 2 hours (±10 minutes) after exposure.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2025.