NCT06547307

Brief Summary

The aim of this randomized, double-blind, placebo-controlled experiment will be to assess the potential effect of the selected gene polymorphism (CYP1A2, ADORA2A) on performance after caffeine ingestion.

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 P50-P75 for not_applicable healthy

Timeline
Completed

Started Aug 2024

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

August 1, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 9, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

5 months

First QC Date

August 1, 2024

Last Update Submit

August 7, 2024

Conditions

Keywords

endurancegenotypecaffeineergogenic effect

Outcome Measures

Primary Outcomes (1)

  • Efficacy of caffeine to improve endurance performance (time to complete 10 km trial)

    To determine if caffeine intake improves endurance performance compared to placebo. Efficacy of caffeine doses (2 mg/kg and 4 mg/kg) to shorten the time needed to complete the 10 km time trial.

    2 Hours

Secondary Outcomes (1)

  • Caffeine ingestion and genotype interaction

    1 day

Study Arms (3)

Caffeine 2 mg

ACTIVE COMPARATOR

To compare exercise performance of 2 or 4 mg of caffeine per kilogram of body weight to placebo within subjects. Subjects will perform one exercise test (10 km cycling time trial).

Dietary Supplement: Caffeine 2 mg

Caffeine 4 mg

ACTIVE COMPARATOR

To compare exercise performance of 2 or 4 mg of caffeine per kilogram of body weight to placebo within subjects. Subjects will perform one exercise test (10 km cycling time trial).

Dietary Supplement: Caffeine 4 mg

Placebo

PLACEBO COMPARATOR

To compare exercise performance of 2 or 4 mg of caffeine per kilogram of body weight to placebo within subjects. Subjects will perform one exercise test (10 km cycling time trial).

Dietary Supplement: Caffeine 0 mg

Interventions

Caffeine 2 mgDIETARY_SUPPLEMENT

To compare exercise performance of 2 or 4 mg of caffeine per kilogram of body weight to placebo within subjects.

Caffeine 2 mg
Caffeine 4 mgDIETARY_SUPPLEMENT

To compare exercise performance of 2 or 4 mg of caffeine per kilogram of body weight to placebo within subjects.

Caffeine 4 mg
Caffeine 0 mgDIETARY_SUPPLEMENT

To compare exercise performance of 2 or 4 mg of caffeine per kilogram of body weight to placebo within subjects.

Placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy person
  • any training status
  • within age limits
  • without contraindications to perform the test on a bicycle trainer
  • No contraindications to caffeine intake

You may not qualify if:

  • Pregnancy
  • Breast feeding
  • Cardiovascular disease
  • Hypertension
  • Liver disease in the previous two months
  • Taking drugs that can affect liver function
  • Illness in the period of 14 days before the start of the research
  • Use of caffeine during research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Masaryk University

Brno, Czechia

RECRUITING

MeSH Terms

Interventions

Caffeine

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Lucie Lipková

    Masaryk University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2024

First Posted

August 9, 2024

Study Start

August 1, 2024

Primary Completion

January 1, 2025

Study Completion

March 1, 2025

Last Updated

August 9, 2024

Record last verified: 2024-08

Locations