The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Caffeine Ingestion on the Biomechanics of Healthy Young Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06039358
Recruitment Status : Completed
First Posted : September 15, 2023
Last Update Posted : January 9, 2024
Sponsor:
Collaborators:
Generalitat de Catalunya
European Union
Information provided by (Responsible Party):
University of Vic - Central University of Catalonia

Brief 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.


Condition or disease Intervention/treatment Phase
Caffeine Biomechanics Fatigue Injuries Physical Activity Dietary Supplement: Caffeine. Drug: Cellulose. Not Applicable

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: The assessed sessions, which will be identical, will be the control, the caffeine, and the placebo ones. The last two sessions mentioned will be performed in a randomized order.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: The placebo and the caffeine ingestion protocols will be identical in format and presentation. To minimize any influence of the flavor or the look of the ingested substance, both conditions will imply the consumption of opaque capsules (ingested with water) in which there will be 6mg/kg of caffeine or placebo.
Primary Purpose: Basic Science
Official Title: Influence of 6mg/kg of Caffeine Supplementation on the Technical Execution of General Movement Patterns Performed by Healthy Subjects, With and Without Neuromuscular Fatigue: a Randomized, Double-blind, Placebo-controlled, Crossover Trial
Actual Study Start Date : October 6, 2023
Actual Primary Completion Date : December 22, 2023
Actual Study Completion Date : December 23, 2023


Arm Intervention/treatment
Experimental: Control - caffeine - placebo.
The order of the assessed sessions will be first the control one, then the caffeine one, and then the placebo one.
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).
Other Name: Placebo.

Experimental: Control - placebo - caffeine.
The order of the assessed sessions will be first the control one, then the placebo one, and then the caffeine one.
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).
Other Name: Placebo.




Primary Outcome Measures :
  1. Knee flexion angle at the midstance while running. [ Time Frame: During the control, placebo, and caffeine sessions (at least 7 days between them). The length of each session will be approximately 3 hours. ]
    Assessment of the knee flexion angle (in degrees). The measurement will be done before and after a fatiguing protocol. Assessed using kinematic instruments.

  2. Ankle dorsiflexion angle at the midstance while running. [ Time Frame: During the control, placebo, and caffeine sessions (at least 7 days between them). The length of each session will be approximately 3 hours. ]
    Assessment of the ankle dorsiflexion angle (in degrees). The measurement will be done before and after a fatiguing protocol. Assessed using kinematic instruments.

  3. Step rate while running. [ Time Frame: During the control, placebo, and caffeine sessions (at least 7 days between them). The length of each session will be approximately 3 hours. ]
    Assessment of the step rate (in steps/minute). The measurement will be done before and after a fatiguing protocol. Assessed using kinematic instruments.

  4. Contact time while running. [ Time Frame: During the control, placebo, and caffeine sessions (at least 7 days between them). The length of each session will be approximately 3 hours. ]
    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.

  5. Stride length while running. [ Time Frame: During the control, placebo, and caffeine sessions (at least 7 days between them). The length of each session will be approximately 3 hours. ]
    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.

  6. Flight time while running. [ Time Frame: During the control, placebo, and caffeine sessions (at least 7 days between them). The length of each session will be approximately 3 hours. ]
    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.

  7. Running performance modification. [ Time Frame: During the control, placebo, and caffeine sessions (at least 7 days between them). The length of each session will be approximately 3 hours. ]
    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.

  8. Hip angle while squatting, at the initial position, bottom position, and final position, and the eccentric and the concentric range of movement. [ Time Frame: During the control, placebo, and caffeine sessions (at least 7 days between them). The length of each session will be approximately 3 hours. ]
    Assessment of the hip angle (in degrees). The measurement will be done before and after a fatiguing protocol. Assessed using kinematic instruments.

  9. Knee angle while squatting, at the initial position, bottom position, and final position, and the eccentric and the concentric range of movement. [ Time Frame: During the control, placebo, and caffeine sessions (at least 7 days between them). The length of each session will be approximately 3 hours. ]
    Assessment of the knee angle (in degrees). The measurement will be done before and after a fatiguing protocol. Assessed using kinematic instruments.

  10. Ankle angle while squatting, at the initial position, bottom position, and final position, and the eccentric and the concentric range of movement. [ Time Frame: During the control, placebo, and caffeine sessions (at least 7 days between them). The length of each session will be approximately 3 hours. ]
    Assessment of the ankle angle (in degrees). The measurement will be done before and after a fatiguing protocol. Assessed using kinematic instruments.

  11. Execution time while squatting, for the eccentric and the concentric phases of the movement. [ Time Frame: During the control, placebo, and caffeine sessions (at least 7 days between them). The length of each session will be approximately 3 hours. ]
    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.

  12. Peak vertical force while squatting, for the eccentric and the concentric phases of the movement. [ Time Frame: During the control, placebo, and caffeine sessions (at least 7 days between them). The length of each session will be approximately 3 hours. ]
    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.

  13. Rate of force development while squatting, for the eccentric and the concentric phases of the movement. [ Time Frame: During the control, placebo, and caffeine sessions (at least 7 days between them). The length of each session will be approximately 3 hours. ]
    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.

  14. Squatting performance modification. [ Time Frame: During the control, placebo, and caffeine sessions (at least 7 days between them). The length of each session will be approximately 3 hours. ]
    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.

  15. Contralateral pelvic drop angle while jumping, at the initial contact of the landing phase. [ Time Frame: During the control, placebo, and caffeine sessions (at least 7 days between them). The length of each session will be approximately 3 hours. ]
    Assessment of the contralateral pelvic drop angle (in degrees). The measurement will be done before and after a fatiguing protocol. Assessed using kinematic instruments.

  16. 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. [ Time Frame: During the control, placebo, and caffeine sessions (at least 7 days between them). The length of each session will be approximately 3 hours. ]
    Assessment of the knee valgus angle (in degrees). The measurement will be done before and after a fatiguing protocol. Assessed using kinematic instruments.

  17. Unweighting phase duration while jumping (jumping phase). [ Time Frame: During the control, placebo, and caffeine sessions (at least 7 days between them). The length of each session will be approximately 3 hours. ]
    Assessment of the unweighting phase duration (in seconds). The measurement will be done before and after a fatiguing protocol. Assessed using force plates.

  18. Braking phase duration while jumping (jumping phase). [ Time Frame: During the control, placebo, and caffeine sessions (at least 7 days between them). The length of each session will be approximately 3 hours. ]
    Assessment of the braking phase duration (in seconds). The measurement will be done before and after a fatiguing protocol. Assessed using force plates.

  19. Propulsive phase duration while jumping (jumping phase). [ Time Frame: During the control, placebo, and caffeine sessions (at least 7 days between them). The length of each session will be approximately 3 hours. ]
    Assessment of the propulsive phase duration (in seconds). The measurement will be done before and after a fatiguing protocol. Assessed using force plates.

  20. Relative peak power output while jumping (jumping phase). [ Time Frame: During the control, placebo, and caffeine sessions (at least 7 days between them). The length of each session will be approximately 3 hours. ]
    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.

  21. Jumping performance modification. [ Time Frame: During the control, placebo, and caffeine sessions (at least 7 days between them). The length of each session will be approximately 3 hours. ]
    Assessment of the height (in meters) of countermovement jumps. The measurement will be done before and after a fatiguing protocol. Assessed using force plates.


Secondary Outcome Measures :
  1. Supplementation identification. [ Time Frame: During the placebo and caffeine sessions (at least 7 days between them). The length of each session will be approximately 3 hours. ]
    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.

  2. Side effects. [ Time Frame: 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. ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06039358


Locations
Layout table for location information
Spain
University of Vic - Central University of Catalonia.
Vic., Barcelona., Spain, 08500.
Sponsors and Collaborators
University of Vic - Central University of Catalonia
Generalitat de Catalunya
European Union
Investigators
Layout table for investigator information
Principal Investigator: Arnau Baena Riera, MSc. Sport, Exercise, and Human Movement (SEaHM), University of Vic - Central University of Catalonia.
  Study Documents (Full-Text)

Documents provided by University of Vic - Central University of Catalonia:
Study Protocol  [PDF] August 15, 2023

Layout table for additonal information
Responsible Party: University of Vic - Central University of Catalonia
ClinicalTrials.gov Identifier: NCT06039358    
Other Study ID Numbers: CAFBIOM001
First Posted: September 15, 2023    Key Record Dates
Last Update Posted: January 9, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Vic - Central University of Catalonia:
Ergogenic aids
Kinematics
Kinetics
Neuromuscular fatigue
Acute and chronic injuries
Jump
Squat
Running
Additional relevant MeSH terms:
Layout table for MeSH terms
Fatigue
Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents