NCT06606639

Brief Summary

Introduction: Various studies have evaluated and verified the ergogenic effect of acute caffeine intake on sports performance, specifically on strength and power performance. However, all experimental investigations designed so far have been based on the comparison of the \"caffeine\" and \"placebo\" conditions in a single trial, not considering the reproducibility and variability of caffeine in multiple trials. Objectives: The present study aims to evaluate the reproducibility and replicability of the acute effect of caffeine intake on energy metabolism and the muscular production of force, power and endurance, according to sex (men vs women) and type of exercise ( bench press vs squat).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

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 8, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 23, 2024

Completed
Last Updated

May 25, 2025

Status Verified

May 1, 2025

Enrollment Period

5 months

First QC Date

September 9, 2024

Last Update Submit

May 23, 2025

Conditions

Outcome Measures

Primary Outcomes (9)

  • Mean velocity at different %1RM

    Measuring bar mean velocity desplacement during bench press and back squat exercises.

    Through study completion, an average of 4 weeks

  • Peak velocity at different %1RM

    Measuring bar peak velocity and time to reach peak velocity of bar desplacement during bench press and back squat exercises.

    Through study completion, an average of 4 weeks

  • Mean power output at different %1RM

    Measuring during bench press and back squat exercises.

    Through study completion, an average of 4 weeks

  • Peak power output and time to reach peak power output at different %1RM

    Measuring during bench press and back squat exercises.

    Through study completion, an average of 4 weeks

  • Number of repetitions performed in 1 set at 65%1RM until task failure

    In bench press and back squat exercises

    Through study completion, an average of 4 weeks

  • Bar velocity deplacement performed in 1 set at 65%1RM until task failure

    In bench press and back squat exercises

    Through study completion, an average of 4 weeks

  • Power output generated in 1 set at 65%1RM until task failure

    In bench press and back squat exercise

    Through study completion, an average of 4 weeks

  • Resting Metabolic Rate (RMR)

    Kcal at rest measuring (RMR) using a metabolic chart.

    Through study completion, an average of 4 weeks

  • Maximal Fat Oxidation Rate (MFO)

    g/min (MFO) using a metabolic chart.

    Through study completion, an average of 4 weeks

Secondary Outcomes (6)

  • Physical activity (METs-min/wk)

    Through study completion, an average of 4 weeks

  • Dietary (g/kg of macronutrients)

    Through study completion, an average of 4 weeks

  • Mood state

    Through study completion, an average of 4 weeks

  • Adverse effects

    Through study completion, an average of 4 weeks

  • Fat mass

    Through study completion, an average of 4 weeks

  • +1 more secondary outcomes

Study Arms (5)

Caffeine - Trial 1

EXPERIMENTAL
Dietary Supplement: Caffeine

Caffeine - Trial 2

EXPERIMENTAL
Dietary Supplement: Caffeine

Caffeine - Trial 3

EXPERIMENTAL
Dietary Supplement: Caffeine

Placebo - Trial 1

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Placebo - Trial 2

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

CaffeineDIETARY_SUPPLEMENT

acute caffeine intake (3 mg/kg)

Caffeine - Trial 1Caffeine - Trial 2Caffeine - Trial 3
PlaceboDIETARY_SUPPLEMENT

Acute placebo intake (3 mg/kg of maltodextrin)

Placebo - Trial 1Placebo - Trial 2

Eligibility Criteria

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

You may qualify if:

  • Age between ≥ 18 and ≤ 35 years.
  • Body Mass Index (BMI) \< 25 kg/m².
  • Resistance-trained individuals (\> 2 years of structured trained).
  • Healthy men and women without neurological, cardiometabolic, immunological, or physical conditions that prevent them from exercising.
  • Participants must be able to perform the tests described in the following section.

You may not qualify if:

  • History of neuromuscular diseases, heart diseases, or diseases that may affect liver or muscle metabolism.
  • Use of drugs, other stimulants or sport supplements that interfere with the the study dietary supplement.
  • Sedentary habits (\<150 min/week of moderate exercise).
  • Having undergone prolonged periods of forced physical inactivity during the 6 months prior to the study.
  • Performing strenuous exercise during the 48 hours prior to the tests.
  • Failure to replicate the same food intake on the two days of the experiments.
  • Consuming caffeine or any other stimulant after 6 pm the day before the training or tests, to avoid headaches, discomfort, or lethargy among regular caffeine consumers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Facultad de Medicina y Ciencias de la Salud. Universidad de Alcalá

Alcalá de Henares, Madrid, 28805, Spain

Location

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
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Statistician
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 9, 2024

First Posted

September 23, 2024

Study Start

January 8, 2024

Primary Completion

May 22, 2024

Study Completion

May 22, 2024

Last Updated

May 25, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

Locations