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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-35
SponsorLeeds Beckett University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Willing and able to provide written informed consent (in English)

Aged 18-35

Male

Residing at a low altitude (<500m)

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

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

    Dietary supplement

    Nootropic drink containing Anthrocyanins, L-theanie and Enzogenol

  • Placebo

    Dietary supplement

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

Treatment groups

27 Participants
are divided into 2 treatment groups
Group A: Nootropic drinkActive comparator 1 intervention
Group B: Placebo drinkPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline (sea level, pre-supplementation), approximately 1 hour (±10 minutes) after exposure, and 2 hours (±10 minutes) after exposure.
2

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.

Time frame
Baseline (sea level, pre-supplementation), approximately 1 hour (±10 minutes) after exposure, and 2 hours (±10 minutes) after exposure.
3

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.

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.
4

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.

Time frame
Baseline (sea level, pre-supplementation), approximately 1 hour (±10 minutes) after exposure, and 2 hours (±10 minutes) after exposure.

Secondary outcomes

Other outcomes

Sponsors and contacts

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