NCT07562256

Brief Summary

This study investigates how different doses of caffeine affect physical and cognitive performance in female handball players. Caffeine is widely used as a performance-enhancing substance, but its effects may vary depending on the type of performance and the dose consumed. In this randomized, double-blind, placebo-controlled crossover study, participants complete three experimental conditions: placebo, low-dose caffeine (3 mg/kg), and moderate-dose caffeine (6 mg/kg). Each participant receives all conditions in a randomized order, with sufficient time between sessions to avoid carryover effects. The study evaluates three main performance domains relevant to team sports. Physical performance is assessed using an intermittent running test. Cognitive performance is measured using a reaction time task that evaluates attention and inhibitory control. In addition, a throwing test is used to assess sport-specific motor performance. The main objective is to determine whether caffeine produces dose-dependent improvements and whether these effects differ across physical, cognitive, and technical performance domains. The findings aim to provide practical insights for athletes and coaches regarding optimal caffeine use in team sport settings.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 25, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2026

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 24, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 1, 2026

Completed
Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

1 month

First QC Date

April 24, 2026

Last Update Submit

April 24, 2026

Conditions

Keywords

CaffeineDose-responsePhysical performanceCognitive performanceHandball Players

Outcome Measures

Primary Outcomes (3)

  • Flanker Task Reaction Time

    Mean reaction time (ms) during correct trials in the Simplified Eriksen Flanker task, used to assess cognitive processing speed.

    During each experimental session (60 minutes after supplementation)

  • Yo-Yo Intermittent Recovery Test Level 1 Distance

    Total distance covered during the Yo-Yo Intermittent Recovery Test Level 1, used to assess intermittent running performance.

    During each experimental session (60 minutes after supplementation)

  • Throwing Velocity

    Mean ball velocity (km/h) measured during a standardized handball throwing test.

    During each experimental session (60 minutes after supplementation)

Secondary Outcomes (2)

  • Flanker Task Accuracy

    During each experimental session (60 minutes after supplementation)

  • Flanker Effect

    During each experimental session (60 minutes after supplementation)

Study Arms (3)

Placebo Condition

PLACEBO COMPARATOR

Participants receive placebo capsules prior to testing in a randomized

Other: Placebo

Low-Dose Caffeine

EXPERIMENTAL

Participants receive 3 mg/kg caffeine prior to testing in a randomized

Dietary Supplement: Caffeine 3 mg/kg

Moderate-Dose Caffeine

EXPERIMENTAL

Participants receive 6 mg/kg caffeine prior to testing in a randomized

Dietary Supplement: Caffeine 6 mg/kg

Interventions

Caffeine 3 mg/kgDIETARY_SUPPLEMENT

Acute ingestion of caffeine at a dose of 3 mg per kilogram of body mass, administered in capsule form 60 minutes prior to testing.

Low-Dose Caffeine
Caffeine 6 mg/kgDIETARY_SUPPLEMENT

Acute ingestion of caffeine at a dose of 6 mg per kilogram of body mass, administered in capsule form 60 minutes prior to testing.

Moderate-Dose Caffeine
PlaceboOTHER

Ingestion of identical capsules containing polydextrose with no active ingredient, administered 60 minutes prior to testing.

Placebo Condition

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female handball players
  • Regular participation in competitive handball training
  • Minimum of 3 years of handball training experience
  • Free from musculoskeletal injury within the past 6 months

You may not qualify if:

  • Known caffeine sensitivity or allergy
  • Use of medications or supplements that may affect physical or cognitive performance
  • Presence of cardiovascular disease
  • Presence of metabolic disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sinop University

Sinop, Central, 57100, Turkey (Türkiye)

Location

Related Publications (3)

  • Pickering C, Grgic J. Caffeine and Exercise: What Next? Sports Med. 2019 Jul;49(7):1007-1030. doi: 10.1007/s40279-019-01101-0.

    PMID: 30977054BACKGROUND
  • McLellan TM, Caldwell JA, Lieberman HR. A review of caffeine's effects on cognitive, physical and occupational performance. Neurosci Biobehav Rev. 2016 Dec;71:294-312. doi: 10.1016/j.neubiorev.2016.09.001. Epub 2016 Sep 6.

    PMID: 27612937BACKGROUND
  • Guest NS, VanDusseldorp TA, Nelson MT, Grgic J, Schoenfeld BJ, Jenkins NDM, Arent SM, Antonio J, Stout JR, Trexler ET, Smith-Ryan AE, Goldstein ER, Kalman DS, Campbell BI. International society of sports nutrition position stand: caffeine and exercise performance. J Int Soc Sports Nutr. 2021 Jan 2;18(1):1. doi: 10.1186/s12970-020-00383-4.

    PMID: 33388079BACKGROUND

MeSH Terms

Interventions

Caffeine

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 24, 2026

First Posted

May 1, 2026

Study Start

January 25, 2026

Primary Completion

March 10, 2026

Study Completion

March 20, 2026

Last Updated

May 1, 2026

Record last verified: 2026-04

Locations