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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06039358
Other study ID # CAFBIOM001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 6, 2023
Est. completion date December 23, 2023

Study information

Verified date January 2024
Source University of Vic - Central University of Catalonia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Caffeine is one of the few supplements that have enough scientific evidence to state that can notably improve performance, as different remarkable organizations in the sports nutrition context have classified it as an ergogenic aid with strong evidence regarding its efficacy and that is apparently safe. The beneficial effect of this substance on physical and cognitive performance has been identified in aerobic and anaerobic efforts, including aerobic and muscular endurance, power, or strength. However, it seems that the benefits of caffeine are usually measured only by its effect on performance, while a comprehensive analysis of its impact on other aspects of the movement technique of the exercise is not considered. Therefore, although caffeine generates better performance, a null or negative effect may occur on technique execution. As such, some consequences might arise (e.g., an increase in injury risk or a decrease in energy efficiency). The objective of this randomized controlled trial is to assess the influence of caffeine on certain biomechanical parameters of the technique of physical exercises in circumstances without fatigue and under neuromuscular fatigue. The study hypothesis is that caffeine generates modifications in the technical execution of certain movements in fatigued and unfatigued circumstances due to its physiological effects, which may be beneficial for performance and injury prevention. The participants will have to attend 5 sessions (enrollment, familiarization, control, placebo, and caffeine), at least 7 days apart. In the last 3 sessions, different measurements will be done to their technique while jumping, squatting, and running, without fatigue and with it. Other data will be collected throughout the study to contextualize and analyze in more detail the obtained information.


Description:

A detailed description of the study can be found in the protocol uploaded with this registry entry.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date December 23, 2023
Est. primary completion date December 22, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria: - An uninterrupted training time of at least 1 year in the subjects' regular exercise modality (either the person is still training or interrupted the training period during the last year, and with no more than 4 months of detraining). - A good exercise technique of the assessed movement patterns (running, squatting, and jumping). Exclusion Criteria: - Not being 18-30 years old. - Having any relevant medical condition. - Pregnancy. - Smoking. - Regular medication consumption / Medication consumption the days before the sessions during the study. - Other supplementation regular consumption / Other supplementation consumption during the study (excluding sports foods, provided that their goal and nutrients have the objective of substituting the ingestion of regular food (e.g., isotonic drinks, carbohydrates gels, protein powder...), without adding other components that may act as ergogenic substances). - Habitual caffeine consumption of >25mg/day-0,99mg/kg/day.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Caffeine.
Ingestion of opaque capsules with a total dose of 6mg/kg of caffeine, 60 minutes before the beginning of the assessed exercises. A crossover with the other intervention will be done in the next/previous session (depending on the arm).
Drug:
Cellulose.
Ingestion of opaque capsules with cellulose, 60 minutes before the beginning of the assessed exercises. A crossover with the other intervention will be done in the next/previous session (depending on the arm).

Locations

Country Name City State
Spain University of Vic - Central University of Catalonia. Vic. Barcelona.

Sponsors (3)

Lead Sponsor Collaborator
University of Vic - Central University of Catalonia European Union, Generalitat de Catalunya

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Knee flexion angle at the midstance while running. Assessment of the knee flexion angle (in degrees). The measurement will be done before and after a fatiguing protocol. Assessed using kinematic instruments. During the control, placebo, and caffeine sessions (at least 7 days between them). The length of each session will be approximately 3 hours.
Primary Ankle dorsiflexion angle at the midstance while running. Assessment of the ankle dorsiflexion angle (in degrees). The measurement will be done before and after a fatiguing protocol. Assessed using kinematic instruments. During the control, placebo, and caffeine sessions (at least 7 days between them). The length of each session will be approximately 3 hours.
Primary Step rate while running. Assessment of the step rate (in steps/minute). The measurement will be done before and after a fatiguing protocol. Assessed using kinematic instruments. During the control, placebo, and caffeine sessions (at least 7 days between them). The length of each session will be approximately 3 hours.
Primary Contact time while running. Assessment of the time the foot is in contact with the ground (in seconds). The measurement will be done before and after a fatiguing protocol. Assessed using kinematic instruments. During the control, placebo, and caffeine sessions (at least 7 days between them). The length of each session will be approximately 3 hours.
Primary Stride length while running. Assessment of the distance between two successive placements of the same foot (in meters). The measurement will be done before and after a fatiguing protocol. Assessed using kinematic instruments. During the control, placebo, and caffeine sessions (at least 7 days between them). The length of each session will be approximately 3 hours.
Primary Flight time while running. Assessment of the time the foot is not in contact with the ground (in seconds). The measurement will be done before and after a fatiguing protocol. Assessed using kinematic instruments. During the control, placebo, and caffeine sessions (at least 7 days between them). The length of each session will be approximately 3 hours.
Primary Running performance modification. Assessment of the time (in seconds) required to complete a specific distance running on a treadmill. The measurement will be done before and after a fatiguing protocol. Assessed using a stopwatch. During the control, placebo, and caffeine sessions (at least 7 days between them). The length of each session will be approximately 3 hours.
Primary Hip angle while squatting, at the initial position, bottom position, and final position, and the eccentric and the concentric range of movement. Assessment of the hip angle (in degrees). The measurement will be done before and after a fatiguing protocol. Assessed using kinematic instruments. During the control, placebo, and caffeine sessions (at least 7 days between them). The length of each session will be approximately 3 hours.
Primary Knee angle while squatting, at the initial position, bottom position, and final position, and the eccentric and the concentric range of movement. Assessment of the knee angle (in degrees). The measurement will be done before and after a fatiguing protocol. Assessed using kinematic instruments. During the control, placebo, and caffeine sessions (at least 7 days between them). The length of each session will be approximately 3 hours.
Primary Ankle angle while squatting, at the initial position, bottom position, and final position, and the eccentric and the concentric range of movement. Assessment of the ankle angle (in degrees). The measurement will be done before and after a fatiguing protocol. Assessed using kinematic instruments. During the control, placebo, and caffeine sessions (at least 7 days between them). The length of each session will be approximately 3 hours.
Primary Execution time while squatting, for the eccentric and the concentric phases of the movement. Assessment of the execution time to perform the eccentric and the concentric phases of the squat (in seconds). The measurement will be done before and after a fatiguing protocol. Assessed using a linear position transducer. During the control, placebo, and caffeine sessions (at least 7 days between them). The length of each session will be approximately 3 hours.
Primary Peak vertical force while squatting, for the eccentric and the concentric phases of the movement. Assessment of the peak vertical force (in Newtons). The measurement will be done before and after a fatiguing protocol. Assessed using a linear position transducer. During the control, placebo, and caffeine sessions (at least 7 days between them). The length of each session will be approximately 3 hours.
Primary Rate of force development while squatting, for the eccentric and the concentric phases of the movement. Assessment of the rate of force development (in Newtons/seconds). The measurement will be done before and after a fatiguing protocol. Assessed using a linear position transducer. During the control, placebo, and caffeine sessions (at least 7 days between them). The length of each session will be approximately 3 hours.
Primary Squatting performance modification. Assessment of the mean propulsive bar velocity (in meters/seconds) for a specific weight lifted in barbell back squats. The measurement will be done before and after a fatiguing protocol. Assessed using a linear position transducer. During the control, placebo, and caffeine sessions (at least 7 days between them). The length of each session will be approximately 3 hours.
Primary Contralateral pelvic drop angle while jumping, at the initial contact of the landing phase. Assessment of the contralateral pelvic drop angle (in degrees). The measurement will be done before and after a fatiguing protocol. Assessed using kinematic instruments. During the control, placebo, and caffeine sessions (at least 7 days between them). The length of each session will be approximately 3 hours.
Primary Knee valgus while jumping, at the initial contact and the deepest landing position of the landing phase, and the range of movement between these two moments. Assessment of the knee valgus angle (in degrees). The measurement will be done before and after a fatiguing protocol. Assessed using kinematic instruments. During the control, placebo, and caffeine sessions (at least 7 days between them). The length of each session will be approximately 3 hours.
Primary Unweighting phase duration while jumping (jumping phase). Assessment of the unweighting phase duration (in seconds). The measurement will be done before and after a fatiguing protocol. Assessed using force plates. During the control, placebo, and caffeine sessions (at least 7 days between them). The length of each session will be approximately 3 hours.
Primary Braking phase duration while jumping (jumping phase). Assessment of the braking phase duration (in seconds). The measurement will be done before and after a fatiguing protocol. Assessed using force plates. During the control, placebo, and caffeine sessions (at least 7 days between them). The length of each session will be approximately 3 hours.
Primary Propulsive phase duration while jumping (jumping phase). Assessment of the propulsive phase duration (in seconds). The measurement will be done before and after a fatiguing protocol. Assessed using force plates. During the control, placebo, and caffeine sessions (at least 7 days between them). The length of each session will be approximately 3 hours.
Primary Relative peak power output while jumping (jumping phase). Assessment of the relative peak power output (in Watts/kg). The measurement will be done before and after a fatiguing protocol. Assessed using force plates. During the control, placebo, and caffeine sessions (at least 7 days between them). The length of each session will be approximately 3 hours.
Primary Jumping performance modification. Assessment of the height (in meters) of countermovement jumps. The measurement will be done before and after a fatiguing protocol. Assessed using force plates. During the control, placebo, and caffeine sessions (at least 7 days between them). The length of each session will be approximately 3 hours.
Secondary Supplementation identification. Assessment of the participants' perception regarding the ingested substance. They will have to complete a questionnaire immediately before (1 hour post-supplementation) and after the assessed exercises, indicating what substance they believe that they have consumed, with the options "caffeine", "placebo", or "I don't know", as well as the reason why they have chosen that answer. During the placebo and caffeine sessions (at least 7 days between them). The length of each session will be approximately 3 hours.
Secondary Side effects. Assessment of the participant's side effects related to caffeine consumption. In the morning of the day after the sessions, they will be requested to complete a questionnaire comprised of 8 questions with a yes/no answer, to evaluate the side effects of caffeine consumption during the hours after the sessions. During the day after the placebo and caffeine sessions (at least 7 days between them). The length of each session will be approximately 3 hours.
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