NCT07047105

Brief Summary

The goal of this clinical trial is to learn if a Nepalese Pepper Extract (Zanthoxlum Armatum, ZA) supplement can improve cognitive performance and mental abilities in competitive gamers aged 16 to 34. The main questions it aims to answer are:

  • Complete a screening visit with health checks and training on computer tasks
  • Attend four testing visits (7-14 days apart) where they receive different treatments
  • Avoid alcohol and energy drinks for 24 hours before each visit, and caffeine from waking
  • Take assigned treatment at 11:30am and complete cognitive tests at -1, 1, 3, and 5 hours in relation to dose.
  • Complete mood questionnaires, sleep assessments, and gaming-specific tasks (aim training, character control)
  • Wear heart rate monitors during testing
  • Eat standardized meals provided during visits
  • Play competitive games at home in the evening and complete performance questionnaires

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2025

Completed
9 days until next milestone

Study Start

First participant enrolled

June 13, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 2, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

July 2, 2025

Status Verified

June 1, 2025

Enrollment Period

7 months

First QC Date

June 4, 2025

Last Update Submit

June 23, 2025

Conditions

Keywords

CognitionMoodGamingPerformanceEsportsNepalese PepperTimut PepperZanthoxylum ArmatumFatigue

Outcome Measures

Primary Outcomes (2)

  • Speed of Attention

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

    Prior to intervention on each testing visit for each arm, along with post dose 1 hour, post dose 3 hour and post dose 5 hour.

  • Subjective Fatigue

    Following completion of Cognitive Demand Battery subjective fatigue will be assessed through self assessment of fatigue levels.

    Prior to intervention on each testing visit for each arm, along with post dose 1 hour, post dose 3 hour and post dose 5 hour.

Secondary Outcomes (15)

  • Accuracy of Attention

    Prior to intervention on each testing visit for each arm, along with post dose 1 hour, post dose 3 hour and post dose 5 hour.

  • Speed of Performance

    Prior to intervention on each testing visit for each arm, along with post dose 1 hour, post dose 3 hour and post dose 5 hour.

  • Accuracy of Performance

    Prior to intervention on each testing visit for each arm, along with post dose 1 hour, post dose 3 hour and post dose 5 hour.

  • Working memory

    Prior to intervention on each testing visit for each arm, along with post dose 1 hour, post dose 3 hour and post dose 5 hour.

  • Speed of memory

    Prior to intervention on each testing visit for each arm, along with post dose 1 hour, post dose 3 hour and post dose 5 hour.

  • +10 more secondary outcomes

Study Arms (4)

ZA 150mg

EXPERIMENTAL

150mg dosage of Nepalese Pepper (Zanthoxylum Armatum) extract in capsule form. Consumed during testing visit to measure acute effects over day of consumption.

Dietary Supplement: Nepalese Pepper (Zanthoxylum Armatum) extract 150mg

ZA 300mg

EXPERIMENTAL

300mg dosage of Nepalese Pepper (Zanthoxylum Armatum) extract in capsule form. Consumed during testing visit to measure acute effects over day of consumption.

Dietary Supplement: Nepalese Pepper (Zanthoxylum Armatum) extract 300mg

Caffeine

ACTIVE COMPARATOR

75mg dose of caffeine (Caffeine anhydrous Pulver) in capsule form. Consumed during testing visit to measure acute effects over day of consumption.

Dietary Supplement: Caffeine 75mg

Placebo

PLACEBO COMPARATOR

Inert placebo, Microcristalline Cellulose MCC, delivered in capsule in form.

Dietary Supplement: Placebo

Interventions

The intervention is a powdered form of Zanthoxylum Armatum (ZA) extract delivered in capsule form. The dosage is 150mg.

Also known as: Timut Pepper
ZA 150mg

The intervention is a powdered form of Zanthoxylum Armatum (ZA) extract delivered in capsule form. The dosage is 300mg.

ZA 300mg
PlaceboDIETARY_SUPPLEMENT

Microcristalline Cellulose MCC

Placebo
Caffeine 75mgDIETARY_SUPPLEMENT

Caffeine anhydrous Pulver, 75mg

Caffeine

Eligibility Criteria

Age16 Years - 34 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Aged 16 to 34 years inclusive
  • Males and females
  • Self-report of good health
  • Usually a regular (at least once per week) player of competitive multiplayer games, (prospective participants will be asked to contact the researchers to discuss their gaming habits if uncertain that they meet the criteria).

You may not qualify if:

  • 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
  • Are pregnant, seeking to become pregnant or lactating
  • Have learning and/or behavioural diagnoses such as dyslexia or ADHD
  • Have a visual impairment that cannot be corrected with glasses or contact lenses (including colour-blindness)
  • Smoke tobacco or vape nicotine or use nicotine replacement products
  • Excessive caffeine intake (\> 500 mg per day). If participants consume energy drinks they will be asked to refrain from this for 24 hour prior to attending testing.
  • Have relevant food intolerances/sensitivities, including caffeine sensitivity.
  • Have taken antibiotics within the past 4 weeks
  • Have taken dietary supplements e.g. Vitamins, omega 3 fish oils etc. in the last 4 weeks (Note: participation is possible following a 4-week supplement washout prior to participating and for the duration of the study on the proviso that the supplements they are taken are out of choice and not medically prescribed or advised)
  • Have any health condition that would prevent fulfilment of the study requirements (this includes non-diagnosed conditions for which no medication may be taken)
  • Are unable to complete all of the study assessments
  • Are currently participating in other clinical or nutrition intervention studies, or have done so in the past 4 weeks
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northumbria University - Brain Performance and Nutrition Research Centre

Newcastle upon Tyne, United Kingdom

RECRUITING

MeSH Terms

Conditions

Fatigue

Interventions

Caffeine

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Central Study Contacts

Philippa A Jackson, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Treatment will be blinded according to the randomisation schedule by a researcher who has no other involvement in the study.
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Randomised, double-blind, placebo-controlled, four-arm crossover design.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2025

First Posted

July 2, 2025

Study Start

June 13, 2025

Primary Completion

January 1, 2026

Study Completion

May 1, 2026

Last Updated

July 2, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations