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CompletedNCT06606639Updated May 25, 2025

Reproducibility of Acute Caffeine Effect

An interventional study of Caffeine and Placebo in Caffeine and Resistance Exercise, sponsored by University of Alcala. Completed at 1 site in Spain. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-25.

Sponsored by University of Alcala · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Jan 2024, registered Sep 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Caffeine and Resistance Exercise
03

In context

Lead sponsor

University of Alcala is the lead sponsor of 123 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    Caffeine - Trial 1

    Dietary Supplement: Caffeine

  • Experimental
    Caffeine - Trial 2

    Dietary Supplement: Caffeine

  • Experimental
    Caffeine - Trial 3

    Dietary Supplement: Caffeine

  • Placebo comparator
    Placebo - Trial 1

    Dietary Supplement: Placebo

  • Placebo comparator
    Placebo - Trial 2

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementCaffeine

    acute caffeine intake (3 mg/kg)

  • Dietary supplementPlacebo

    Acute placebo intake (3 mg/kg of maltodextrin)

06

What researchers measure

Primary outcomes

  1. Mean velocity at different %1RM

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

    Time frame: Through study completion, an average of 4 weeks

  2. 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.

    Time frame: Through study completion, an average of 4 weeks

  3. Mean power output at different %1RM

    Measuring during bench press and back squat exercises.

    Time frame: Through study completion, an average of 4 weeks

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

    Measuring during bench press and back squat exercises.

    Time frame: Through study completion, an average of 4 weeks

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

    In bench press and back squat exercises

    Time frame: Through study completion, an average of 4 weeks

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

    In bench press and back squat exercises

    Time frame: Through study completion, an average of 4 weeks

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

    In bench press and back squat exercise

    Time frame: Through study completion, an average of 4 weeks

  8. Resting Metabolic Rate (RMR)

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

    Time frame: Through study completion, an average of 4 weeks

  9. Maximal Fat Oxidation Rate (MFO)

    g/min (MFO) using a metabolic chart.

    Time frame: Through study completion, an average of 4 weeks

Secondary outcomes

  1. Physical activity (METs-min/wk)

    Using IPAQ

    Time frame: Through study completion, an average of 4 weeks

  2. Dietary (g/kg of macronutrients)

    Using 24-total recall

    Time frame: Through study completion, an average of 4 weeks

  3. Mood state

    Mood. Participants graded a set of 29 items related to the mood on a Likert scale from 0 (not at all) to 4 (extremely) in reply to the question;How do you feel at this moment?; to assess six scales: tension, depression, anger, vigor, fatigue and confusion.

    Time frame: Through study completion, an average of 4 weeks

  4. Adverse effects

    Adverse effects. perception of power, endurance, energy and exertion, as well as heart, muscular and gastrointestinal discomfort.

    Time frame: Through study completion, an average of 4 weeks

  5. Fat mass

    Using electrical bioimpedance (kg and % of body mass)

    Time frame: Through study completion, an average of 4 weeks

  6. Fat-free mass

    Using electrical bioimpedance (kg and % of body mass)

    Time frame: Through study completion, an average of 4 weeks

07

Study locations

1 site
  • Facultad de Medicina y Ciencias de la Salud. Universidad de Alcalá
    Alcalá de Henares, Madrid 28805, Spain
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06606639
Lead sponsor
University of Alcala
Responsible party
Alberto Pérez-López (Principal Investigator, University of Alcala) — Principal investigator
First posted
Sep 23, 2024
Start date
Jan 8, 2024
Primary completion
May 22, 2024
Completion
May 22, 2024
Last update
May 25, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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