Investigation on the Chronic Effects of Nepalese Pepper (Zanthoxylum Armatum DC) on Cognitive Function, Mood and Gaming Performance in Young, Healthy, Action Video Gamers

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-39
SponsorNorthumbria University

About this trial

The goal of this clinical trial is to learn if daily supplementation with a Nepalese Pepper Extract (Zanthoxylum Armatum, ZA) can improve cognitive performance and gaming performance in action video gamers aged 16 to 39, when taken over an extended period. The main questions it aims to answer are:

Does chronic (42-day) daily ZA supplementation improve speed of cognitive performance and reduce subjective mental fatigue? Do these effects translate into objective and self-reported improvements in gaming performance? Are there additional acute (within-session) effects at the end of a chronic supplementation period, on top of any chronic effect?

Researchers will compare 275mg daily ZA supplementation to placebo to see if chronic ZA produces better cognitive performance and lower fatigue than placebo. Participants will:

Complete a screening call and a training visit on the computerised cognitive tasks and gaming tasks Take a daily capsule (either ZA or placebo, depending on treatment order) each morning with food for 42 days, then switch to the other treatment for a further 42 days after a 2-week washout Attend four testing visits at the research centre: a baseline and an endpoint visit for each 42-day treatment period Avoid alcohol and energy drinks for 24 hours before each testing visit, and caffeine from waking Complete cognitive tests before dosing and 1 hour after dosing at each testing visit Complete mood and sleep questionnaires Wear a heart rate monitor at rest on arrival at each visit Complete gaming-specific tasks (aim training, MOBA character control, multi-tasking, finger tapping, Fitts' Law, multiple object tracking, collision prediction) Play their action video game of choice at home throughout each 42-day period and complete performance questionnaires

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Aged 16 to 39 years inclusive

Males and females

Self-report of good health

Usually a regular (at least 5 hours per week on average) player of action video games, including but not limited to First-Person Shooters (FPS) and Massive Online Battle Arenas (MOBA), (prospective participants will be asked to contact the researchers to discuss their gaming habits if uncertain that they meet the criteria).

Disqualifiers

Have any pre-existing medical condition/illness which will impact taking part in the study (i.e. participants may be allowed to progress to screening if they have a condition/illness which would not interact with the active treatments or impede performance).

Are currently taking prescription medications. NOTE: the explicit exceptions to this are contraceptive treatments for female participants, and those taken 'as needed' in the treatment of asthma and hay fever. There may be other instances of medication use which, where no interaction with the active treatments is likely, and which would not be expected to have any impact on brain function, participants may be able to progress to screening.

Have high blood pressure (systolic over 139 mm Hg or diastolic over 89 mm Hg); or have low blood pressure (systolic below 90 mm Hg or diastolic below 60 mm Hg)

Have a Body Mass Index (BMI) outside of the range 18.5-35 kg/m2

Trial design

Design model

Crossover

Treatments tested in this trial

  • Nepalese Pepper (Zanthoxylum Armatum DC) extract 275mg

    Dietary supplement

    The intervention is a powdered form of Zanthoxylum Armatum (ZA) extract (SaraPepp™ Nu) delivered in capsule form, taken once daily with food for a 42-day supplementation period. The dosage is 275mg.

  • Placebo

    Dietary supplement

    Microcrystalline Cellulose (MCC), delivered in capsule form, taken once daily for a 42-day supplementation period.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: ZA 275mgExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Subjective Fatigue

Self-assessed fatigue level following each of three completions of the Cognitive Demand Battery (CDB).

Time frame
Assessed at pre-dose baseline and 1hr post-dose, on the Baseline and Endpoint visit of each 42-day treatment arm.
2

Speed of Performance

Composite outcome derived from combined performance on Serial 3 Subtractions, Simple Reaction Time, Choice Reaction Time, Numeric Working Memory, RVIP, Delayed Picture Recognition, and Delayed Word Recognition tasks from the COMPASS battery.

Time frame
Assessed at pre-dose baseline and 1hr post-dose, on the Baseline and Endpoint visit of each 42-day treatment arm.

Secondary outcomes

1

Accuracy of Attention

Score calculated through combined performance on Rapid Visual Information Processing, RVIP, and Choice Reaction Time tasks.

Time frame
Assessed at pre-dose baseline and 1hr post-dose, on the Baseline and Endpoint visit of each 42-day treatment arm.
2

Speed of Attention

Score calculated through combined performance on Rapid Visual Information Processing, Simple Reaction Time, and Choice Reaction Time tasks.

Time frame
Assessed at pre-dose baseline and 1hr post-dose, on the Baseline and Endpoint visit of each 42-day treatment arm.
3

Accuracy of Performance

Score calculated through combined performance on Immediate Word Recall, Choice Reaction Time, Corsi Blocks, Stroop, RVIP, Delayed Word Recall, Delayed Picture Recognition, and Delayed Word Recognition.

Time frame
Assessed at pre-dose baseline and 1hr post-dose, on the Baseline and Endpoint visit of each 42-day treatment arm.
4

Working Memory

Score calculated through combined performance on Numeric Working Memory and Corsi Blocks tasks.

Time frame
Assessed at pre-dose baseline and 1hr post-dose, on the Baseline and Endpoint visit of each 42-day treatment arm.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northumbria University

Lead sponsor

Solabia Biochemistry AG

Collaborator

This trial is not recruiting at the moment. You can still explore other options: