NCT05995314

Brief Summary

Caffeine is a potent central nervous system stimulant that increases the activity in the prefrontal cortex and can improve cognitive skills. An improvement in these cognitive skills can lead to further benefits in athletic performance. Therefore, it is necessary to clarify the dose-response of caffeine on cognitive performance.The aim of this research will be to determine the effects of different doses of caffeine on sport-related cognitive aspects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2023

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

August 7, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 8, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 16, 2023

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2023

Completed
Last Updated

September 6, 2023

Status Verified

September 1, 2023

Enrollment Period

28 days

First QC Date

August 8, 2023

Last Update Submit

September 4, 2023

Conditions

Keywords

ergogenic aidsport performancereaction timeanticipationattentionmemory

Outcome Measures

Primary Outcomes (4)

  • Reaction Time

    Reaction time (in seconds) shall be assessed with the Dynavision™ D2 Visomotor Device using the "Reaction Time Test". In this test the fastest visual, motor and physical reaction time will be measured.

    10 minutes

  • Anticipation

    Visual acuity related to hand-eye coordination and anticipation will be assessed using the Bassin Anticipation Timer instrument. The best anticipation time (in seconds) of each condition (5, 10 and 15 mph) will be taken.

    5 minutes

  • Sustained attention

    The ability of maintaining the attention and inhibiting an appropriate response will be measured by "Go/No-Go Test" \[fastest, slowest, and average response time (in seconds), and successful attempts (percentage; %)\] and "Eriksen Flanker Test" \[congruent and incongruent reaction time (in seconds)\].

    10 minutes

  • Memory

    To study the modulation of memory storage processes, three 20-item word lists were created. Each word in the list will be presented for 5 s. This will be followed by a 100 s memory consolidation interval, after which there will be a 120 s period in which as many words as the participants can remember will be written down (First time). After 15 min, participants will perform a recall task (Second time) in which they will have to rewrite all the words they remember at that time.

    20 minutes

Study Arms (3)

PLACEBO

PLACEBO COMPARATOR

placebo (0 mg/kg of body mass of caffeine). The capsule will be filled with 3 mg/kg of body mass of cellulose.

Dietary Supplement: PLACEBO

3mg/kg

EXPERIMENTAL

3 mg/kg of body mass of caffeine (99% caffeine, Bulkpowders, United Kingdom).

Dietary Supplement: 3 mg/kg of caffeine

6mg/kg

EXPERIMENTAL

6 mg/kg of body mass of caffeine (99% caffeine, Bulkpowders, United Kingdom).

Dietary Supplement: 6 mg/kg of caffeine

Interventions

PLACEBODIETARY_SUPPLEMENT

3 mg/kg of cellulose (0 mg/kg of caffeine)

PLACEBO
3 mg/kg of caffeineDIETARY_SUPPLEMENT

Ingestion of 3 mg/kg of body mass of caffeine

3mg/kg
6 mg/kg of caffeineDIETARY_SUPPLEMENT

Ingestion of 6 mg/kg of body mass of caffeine

6mg/kg

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Physically active individuals ( \>150 min/week moderate physical activity or \>75 min/week vigorous physical activity)
  • Individuals without serious and undiagnosed health problems.

You may not qualify if:

  • Individuals with color blindness.
  • Regular caffeine consumers (\>3 cups of coffee/day).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Performance and Sport Rehabilitation Laboratory

Toledo, 45071, Spain

Location

Related Publications (1)

  • Ramirez-delaCruz M, Esteban-Garcia P, Abian P, Bravo-Sanchez A, Pinas-Bonilla I, Abian-Vicen J. Effects of different doses of caffeine on cognitive performance in healthy physically active individuals. Eur J Nutr. 2024 Dec;63(8):3025-3035. doi: 10.1007/s00394-024-03486-9. Epub 2024 Sep 4.

MeSH Terms

Interventions

Caffeine

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Javier Abián-Vicén, PhD

    University of Castilla-La Mancha

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
To achieve the blinded placebo situation, a researcher not associated with the study will be performed the blinding and prepared identical capsules containing placebo or the corresponding dose of caffeine. This researcher will be assigned an alphanumeric code to each trial to blind participants and investigators
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2023

First Posted

August 16, 2023

Study Start

August 7, 2023

Primary Completion

September 4, 2023

Study Completion

September 4, 2023

Last Updated

September 6, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations