- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06606639
Reproducibility of Acute Caffeine Effect
Reproducibility of the Acute Effect of Caffeine on Energy Metabolism and Muscular Strength, Power and Endurance Performance
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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Madrid
-
Alcalá de Henares, Madrid, Spain, 28805
- Facultad de Medicina y Ciencias de la Salud. Universidad de Alcalá
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Caffeine - Trial 1
|
acute caffeine intake (3 mg/kg)
|
|
Experimental: Caffeine - Trial 2
|
acute caffeine intake (3 mg/kg)
|
|
Experimental: Caffeine - Trial 3
|
acute caffeine intake (3 mg/kg)
|
|
Placebo Comparator: Placebo - Trial 1
|
Acute placebo intake (3 mg/kg of maltodextrin)
|
|
Placebo Comparator: Placebo - Trial 2
|
Acute placebo intake (3 mg/kg of maltodextrin)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean velocity at different %1RM
Time Frame: Through study completion, an average of 4 weeks
|
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
Time Frame: Through study completion, an average of 4 weeks
|
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
Time Frame: Through study completion, an average of 4 weeks
|
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
Time Frame: Through study completion, an average of 4 weeks
|
Measuring during 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
Time Frame: Through study completion, an average of 4 weeks
|
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
Time Frame: Through study completion, an average of 4 weeks
|
In bench press and back squat exercise
|
Through study completion, an average of 4 weeks
|
|
Number of repetitions performed in 1 set at 65%1RM until task failure
Time Frame: Through study completion, an average of 4 weeks
|
In bench press and back squat exercises
|
Through study completion, an average of 4 weeks
|
|
Resting Metabolic Rate (RMR)
Time Frame: Through study completion, an average of 4 weeks
|
Kcal at rest measuring (RMR) using a metabolic chart.
|
Through study completion, an average of 4 weeks
|
|
Maximal Fat Oxidation Rate (MFO)
Time Frame: Through study completion, an average of 4 weeks
|
g/min (MFO) using a metabolic chart.
|
Through study completion, an average of 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical activity (METs-min/wk)
Time Frame: Through study completion, an average of 4 weeks
|
Using IPAQ
|
Through study completion, an average of 4 weeks
|
|
Dietary (g/kg of macronutrients)
Time Frame: Through study completion, an average of 4 weeks
|
Using 24-total recall
|
Through study completion, an average of 4 weeks
|
|
Mood state
Time Frame: Through study completion, an average of 4 weeks
|
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.
|
Through study completion, an average of 4 weeks
|
|
Adverse effects
Time Frame: Through study completion, an average of 4 weeks
|
Adverse effects.
perception of power, endurance, energy and exertion, as well as heart, muscular and gastrointestinal discomfort.
|
Through study completion, an average of 4 weeks
|
|
Fat mass
Time Frame: Through study completion, an average of 4 weeks
|
Using electrical bioimpedance (kg and % of body mass)
|
Through study completion, an average of 4 weeks
|
|
Fat-free mass
Time Frame: Through study completion, an average of 4 weeks
|
Using electrical bioimpedance (kg and % of body mass)
|
Through study completion, an average of 4 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEID/2024/2/039
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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