Exploring the Cognitive Benefits of a Blackcurrant-Based Supplement in Normobaric Hypoxia

NCT07166835 | Not Yet Recruiting

• 1 other identifier: 151421
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Cognitive Performance; Executive Function (Cognition); Working Memory; Hypoxia Induced Cognitive Impairment; Mood

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

Study Arms (2)

Nootropic drink

ACTIVE COMPARATOR

Nootropic beverage containing anthocyanins, L-theanine, and Enzogenol. Administered orally prior to cognitive testing under simulated normobaric hypoxia.

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.

Dietary Supplement: Placebo

Interventions

Nootropics (ginkgo biloba, nicergoline, piracetam, or others) DIETARY_SUPPLEMENT

Nootropic drink containing Anthrocyanins, L-theanie and Enzogenol

Nootropic drink

Placebo DIETARY_SUPPLEMENT

Taste- and appearance-matched placebo beverage without active ingredients.

Placebo drink

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: cisgendered men
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Willing and able to provide written informed consent (in English)
• Aged 18-35
• Male
• Residing at a low altitude (\<500m)

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Leeds Beckett University: lead

Study Sites (1)

Leeds Beckett University

Leeds, LS6 3QS, United Kingdom

Location

MeSH Terms

Interventions

Nootropic Agents; Ginkgo Extract; Nicergoline; Piracetam

Intervention Hierarchy (Ancestors)

Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures; Ergolines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Isobel R Harris

CONTACT

+44 7443518358; i.harris@leedsbeckett.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 10, 2025
• Study Start: September 1, 2025
• Primary Completion: December 25, 2025
• Study Completion (Estimated): October 1, 2027
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)