CaffeineNCT04642131
Effect of Caffeine Supplementation and Personalized Insoles on Females
A study testing Caffeine supplementation and Personalized insoles in people with Caffeine and Fatigue, run by Universidad de Zaragoza at 1 site in Spain.
Trial summary
Several studies have shown the positive effect that caffeine has on athletic performance related variables. Nonetheless, most studies have been developed in males and have not studied the possible effects on biomechanics and related injuries. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- What is being tested?
- Caffeine supplementation and Personalized insoles
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteSpain
- Study dates
- 9 Dec 2020to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Females
- Soccer players who have been competing for at least 3 years
Who cannot join
- Participants with major injuries in the lower limbs within the 12 months before testing.
- Participants consuming ephedrine or related medicines
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Fatigue, Caffeine Supplementation and Personalized Insoles on Biomechanics and Athletic Performance in Female Adult Soccer Players.
Several studies have shown the positive effect that caffeine has on athletic performance related variables. Nonetheless, most studies have been developed in males and have not studied the possible effects on biomechanics and related injuries. Moreover, the inclusion of personalized insoles could also affect biomechanical patterns and thus injury incidence that has shown to be higher when athletes are fatigued. Therefore, the aim of the present randomized controlled trial is to evaluate the effect of fatigue, caffeine supplementation and personalized insoles on biomechanics and athletic performance in female adult soccer players.
- Conditions
- Caffeine, Fatigue, Injuries, Females Xy, Soccer, Biomechanical Parameters
- Being tested
- Caffeine supplementation, Personalized insoles, Control condition
- Keywords
- women, insoles, kinematics, kinetics, performance, athletics, team sport
- Medical subject headings
- Fatigue, Wounds and Injuries, Disorder of Sex Development, 46,XY
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caffeine supplementationDietary supplement
Participants will wear standard insoles and ingest caffeine in liquid form (3mg/kg) with carbohydrates.
Personalized insolesDevice
Participants will wear personalized insoles and ingest a drink of carbohydrates without caffeine
Control conditionOther
Participants will wear standard insoles and ingest a drink of carbohydrates without caffeine
| Study group | Role | What they receive |
|---|---|---|
| Personalized insoles | Experimental | Personalized insoles without supplementation Receives: Device: Personalized insoles |
| Caffeine supplementation | Experimental | Standard insoles with caffeine supplementation (3mg/kg) Receives: Dietary Supplement: Caffeine supplementation |
| Control condition | Placebo comparator | Standard insoles without supplementation Receives: Other: Control condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agility after fatigue and caffeine supplementation
Assessment of agility in seconds before and after a fatigue protocol is applied. Data will be collected with photoelectric cells.
Measured: One day
Jump height after fatigue and caffeine supplementation
Assessment of jump height in centimetres before and after a fatigue protocol is applied. Data will be collected with force plates.
Measured: One day
Repeated sprint ability after fatigue and caffeine supplementation
Assessment of repeated sprints ability in seconds before and after a fatigue protocol is applied. Data will be collected with photoelectric cells.
Measured: One day
Agility after fatigue and personalized insoles
Assessment of agility in seconds before and after a fatigue protocol is applied. Data will be collected with photoelectric cells.
Measured: One day
Jump height after fatigue and personalized insoles
Assessment of jump height in centimetres before and after a fatigue protocol is applied. Data will be collected with force plates.
Measured: One day
Repeated sprint ability after fatigue and personalized insoles
Assessment of repeated sprints ability in seconds before and after a fatigue protocol is applied. Data will be collected with photoelectric cells.
Measured: One day
Agility after fatigue and placebo
Assessment of agility in seconds before and after a fatigue protocol is applied. Data will be collected with photoelectric cells.
Measured: One day
Jump height after fatigue and placebo
Assessment of jump height in centimetres before and after a fatigue protocol is applied. Data will be collected with force plates.
Measured: One day
Repeated sprint ability after fatigue and placebo
Assessment of repeated sprints ability in seconds before and after a fatigue protocol is applied. Data will be collected with photoelectric cells.
Measured: One day
Hip range of motion after fatigue and caffeine supplementation
Assessment of hip range of motion in degrees assessed with VICON before and after a fatigue protocol is applied. Data will be collected with the VICON motion capture system.
Measured: During the intervention
Knee range of motion after fatigue and caffeine supplementation
Assessment of knee range of motion in degrees assessed with VICON before and after a fatigue protocol is applied. Data will be collected with the VICON motion capture system.
Measured: During the intervention
Ankle range of motion after fatigue and caffeine supplementation
Assessment of ankle range of motion in degrees assessed with VICON before and after a fatigue protocol is applied. Data will be collected with the VICON motion capture system.
Measured: During the intervention
Hip flexion moment after fatigue and caffeine supplementation
Assessment of hip flexion moment in Nm·kg assessed with VICON before and after a fatigue protocol is applied. Data will be collected with the VICON motion capture system.
Measured: During the intervention
Knee flexion moment after fatigue and caffeine supplementation
Assessment of knee flexion moment in Nm·kg assessed with VICON before and after a fatigue protocol is applied. Data will be collected with the VICON motion capture system.
Measured: During the intervention
Ankle flexion moment after fatigue and caffeine supplementation
Assessment of ankle flexion moment in Nm·kg assessed with VICON before and after a fatigue protocol is applied. Data will be collected with the VICON motion capture system.
Measured: During the intervention
Hip range of motion after fatigue and personalized insoles
Assessment of hip range of motion in degrees assessed with VICON before and after a fatigue protocol is applied. Data will be collected with the VICON motion capture system.
Measured: During the intervention
Knee range of motion after fatigue and personalized insoles
Assessment of knee range of motion in degrees assessed with VICON before and after a fatigue protocol is applied. Data will be collected with the VICON motion capture system.
Measured: During the intervention
Ankle range of motion after fatigue and personalized insoles
Assessment of ankle range of motion in degrees assessed with VICON before and after a fatigue protocol is applied. Data will be collected with the VICON motion capture system.
Measured: During the intervention
Hip flexion moment after fatigue and personalized insoles
Assessment of hip flexion moment in Nm·kg assessed with VICON before and after a fatigue protocol is applied. Data will be collected with the VICON motion capture system.
Measured: During the intervention
Knee flexion moment after fatigue and personalized insoles
Assessment of knee flexion moment in Nm·kg assessed with VICON before and after a fatigue protocol is applied. Data will be collected with the VICON motion capture system.
Measured: During the intervention
Ankle flexion moment after fatigue and personalized insoles
Assessment of ankle flexion moment in Nm·kg assessed with VICON before and after a fatigue protocol is applied. Data will be collected with the VICON motion capture system.
Measured: During the intervention
Hip range of motion after fatigue and placebo
Assessment of hip range of motion in degrees assessed with VICON before and after a fatigue protocol is applied. Data will be collected with the VICON motion capture system.
Measured: During the intervention
Knee range of motion after fatigue and placebo
Assessment of knee range of motion in degrees assessed with VICON before and after a fatigue protocol is applied. Data will be collected with the VICON motion capture system.
Measured: During the intervention
Ankle range of motion after fatigue and placebo
Assessment of ankle range of motion in degrees assessed with VICON before and after a fatigue protocol is applied. Data will be collected with the VICON motion capture system.
Measured: During the intervention
Hip flexion moment after fatigue and placebo
Assessment of hip flexion moment in Nm·kg assessed with VICON before and after a fatigue protocol is applied. Data will be collected with the VICON motion capture system.
Measured: During the intervention
Knee flexion moment after fatigue and placebo
Assessment of knee flexion moment in Nm·kg assessed with VICON before and after a fatigue protocol is applied. Data will be collected with the VICON motion capture system.
Measured: During the intervention
Ankle flexion moment after fatigue and placebo
Assessment of ankle flexion moment in Nm·kg assessed with VICON before and after a fatigue protocol is applied. Data will be collected with the VICON motion capture system.
Measured: During the intervention
Secondary outcomes (4)
Injury incidence
Association between the primary outcomes and injury incidence registered through the International Federation of Association Football questionnaire (F-MARC)
Measured: Six months
Sleep disturbances after caffeine ingestion
Rate of patients with sleep problems assessed with the Athens sleep questionnaire
Measured: Immediately after the intervention
Sleep disturbances after personalized insoles
Rate of patients with sleep problems assessed with the Athens sleep questionnaire
Measured: Immediately after the intervention
Sleep disturbances after placebo
Rate of patients with sleep problems assessed with the Athens sleep questionnaire
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start9 Dec 2020
- Primary completion1 Jul 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Why it stopped: Were unable to recruit enough participants and the agreement with the laboratory providing the measurements stoped.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CaffeineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be given a bottle with either caffeine and carbohydrates or just carbohydrates, and personalized insoles or standard insoles. All participants will complete athletic and biomechanics tests before and after completing a 43 minute fatigue protocol.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alejandro Gómez Bruton, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04642131
- Sponsor's protocol ID
- UZCUD2020-BIO-02
- Status last verified
- May 2024
- First submitted
- 6 Nov 2020
- Last updated
- 8 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Fatigue, Caffeine Supplementation and Personalized Insoles on Biomechanics and Athletic Performance in Female Adult Soccer Players.
- ClinicalTrials.gov ID
- NCT04642131
- Acronym / sponsor ID
- UZCUD2020-BIO-02
- Conditions
- Caffeine, Fatigue, Injuries, Females Xy, Soccer, Biomechanical Parameters
- Keywords
- women, insoles, kinematics, kinetics, performance, athletics, team sport
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Were unable to recruit enough participants and the agreement with the laboratory providing the measurements stoped.
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Study start
- 9 Dec 2020 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Several studies have shown the positive effect that caffeine has on athletic performance related variables. Nonetheless, most studies have been developed in males and have not studied the possible effects on biomechanics and related injuries. Moreover, the inclusion of personalized insoles could also affect biomechanical patterns and thus injury incidence that has shown to be higher when athletes are fatigued. Therefore, the aim of the present randomized controlled trial is to evaluate the effect of fatigue, caffeine supplementation and personalized insoles on biomechanics and athletic performance in female adult soccer players.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Participants will be given a bottle with either caffeine and carbohydrates or just carbohydrates, and personalized insoles or standard insoles. All participants will complete athletic and biomechanics tests before and after completing a 43 minute fatigue protocol.
| Arm | Type | Receives |
|---|---|---|
| Personalized insoles | Experimental | Device: Personalized insolesPersonalized insoles without supplementation |
| Caffeine supplementation | Experimental | Dietary Supplement: Caffeine supplementationStandard insoles with caffeine supplementation (3mg/kg) |
| Control condition | Placebo comparator | Other: Control conditionStandard insoles without supplementation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Females
- Soccer players who have been competing for at least 3 years
Key exclusion criteria (2 listed)
- Participants with major injuries in the lower limbs within the 12 months before testing.
- Participants consuming ephedrine or related medicines
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caffeine supplementationParticipants will wear standard insoles and ingest caffeine in liquid form (3mg/kg) with carbohydrates. | Dietary supplement | Caffeine supplementation |
| Personalized insolesParticipants will wear personalized insoles and ingest a drink of carbohydrates without caffeine | Device | Personalized insoles |
| Control conditionParticipants will wear standard insoles and ingest a drink of carbohydrates without caffeine | Other | Control condition |
Primary outcome
Agility after fatigue and caffeine supplementation
Time frame: One day
Assessment of agility in seconds before and after a fatigue protocol is applied. Data will be collected with photoelectric cells.
Jump height after fatigue and caffeine supplementation
Time frame: One day
Assessment of jump height in centimetres before and after a fatigue protocol is applied. Data will be collected with force plates.
Repeated sprint ability after fatigue and caffeine supplementation
Time frame: One day
Assessment of repeated sprints ability in seconds before and after a fatigue protocol is applied. Data will be collected with photoelectric cells.
Agility after fatigue and personalized insoles
Time frame: One day
Assessment of agility in seconds before and after a fatigue protocol is applied. Data will be collected with photoelectric cells.
Jump height after fatigue and personalized insoles
Time frame: One day
Assessment of jump height in centimetres before and after a fatigue protocol is applied. Data will be collected with force plates.
Repeated sprint ability after fatigue and personalized insoles
Time frame: One day
Assessment of repeated sprints ability in seconds before and after a fatigue protocol is applied. Data will be collected with photoelectric cells.
Agility after fatigue and placebo
Time frame: One day
Assessment of agility in seconds before and after a fatigue protocol is applied. Data will be collected with photoelectric cells.
Jump height after fatigue and placebo
Time frame: One day
Assessment of jump height in centimetres before and after a fatigue protocol is applied. Data will be collected with force plates.
Repeated sprint ability after fatigue and placebo
Time frame: One day
Assessment of repeated sprints ability in seconds before and after a fatigue protocol is applied. Data will be collected with photoelectric cells.
Hip range of motion after fatigue and caffeine supplementation
Time frame: During the intervention
Assessment of hip range of motion in degrees assessed with VICON before and after a fatigue protocol is applied. Data will be collected with the VICON motion capture system.
Knee range of motion after fatigue and caffeine supplementation
Time frame: During the intervention
Assessment of knee range of motion in degrees assessed with VICON before and after a fatigue protocol is applied. Data will be collected with the VICON motion capture system.
Ankle range of motion after fatigue and caffeine supplementation
Time frame: During the intervention
Assessment of ankle range of motion in degrees assessed with VICON before and after a fatigue protocol is applied. Data will be collected with the VICON motion capture system.
Hip flexion moment after fatigue and caffeine supplementation
Time frame: During the intervention
Assessment of hip flexion moment in Nm·kg assessed with VICON before and after a fatigue protocol is applied. Data will be collected with the VICON motion capture system.
Knee flexion moment after fatigue and caffeine supplementation
Time frame: During the intervention
Assessment of knee flexion moment in Nm·kg assessed with VICON before and after a fatigue protocol is applied. Data will be collected with the VICON motion capture system.
Ankle flexion moment after fatigue and caffeine supplementation
Time frame: During the intervention
Assessment of ankle flexion moment in Nm·kg assessed with VICON before and after a fatigue protocol is applied. Data will be collected with the VICON motion capture system.
Hip range of motion after fatigue and personalized insoles
Time frame: During the intervention
Assessment of hip range of motion in degrees assessed with VICON before and after a fatigue protocol is applied. Data will be collected with the VICON motion capture system.
Knee range of motion after fatigue and personalized insoles
Time frame: During the intervention
Assessment of knee range of motion in degrees assessed with VICON before and after a fatigue protocol is applied. Data will be collected with the VICON motion capture system.
Ankle range of motion after fatigue and personalized insoles
Time frame: During the intervention
Assessment of ankle range of motion in degrees assessed with VICON before and after a fatigue protocol is applied. Data will be collected with the VICON motion capture system.
Hip flexion moment after fatigue and personalized insoles
Time frame: During the intervention
Assessment of hip flexion moment in Nm·kg assessed with VICON before and after a fatigue protocol is applied. Data will be collected with the VICON motion capture system.
Knee flexion moment after fatigue and personalized insoles
Time frame: During the intervention
Assessment of knee flexion moment in Nm·kg assessed with VICON before and after a fatigue protocol is applied. Data will be collected with the VICON motion capture system.
Ankle flexion moment after fatigue and personalized insoles
Time frame: During the intervention
Assessment of ankle flexion moment in Nm·kg assessed with VICON before and after a fatigue protocol is applied. Data will be collected with the VICON motion capture system.
Hip range of motion after fatigue and placebo
Time frame: During the intervention
Assessment of hip range of motion in degrees assessed with VICON before and after a fatigue protocol is applied. Data will be collected with the VICON motion capture system.
Knee range of motion after fatigue and placebo
Time frame: During the intervention
Assessment of knee range of motion in degrees assessed with VICON before and after a fatigue protocol is applied. Data will be collected with the VICON motion capture system.
Ankle range of motion after fatigue and placebo
Time frame: During the intervention
Assessment of ankle range of motion in degrees assessed with VICON before and after a fatigue protocol is applied. Data will be collected with the VICON motion capture system.
Hip flexion moment after fatigue and placebo
Time frame: During the intervention
Assessment of hip flexion moment in Nm·kg assessed with VICON before and after a fatigue protocol is applied. Data will be collected with the VICON motion capture system.
Knee flexion moment after fatigue and placebo
Time frame: During the intervention
Assessment of knee flexion moment in Nm·kg assessed with VICON before and after a fatigue protocol is applied. Data will be collected with the VICON motion capture system.
Ankle flexion moment after fatigue and placebo
Time frame: During the intervention
Assessment of ankle flexion moment in Nm·kg assessed with VICON before and after a fatigue protocol is applied. Data will be collected with the VICON motion capture system.
4 secondary outcomes
Injury incidence
Time frame: Six months
Sleep disturbances after caffeine ingestion
Time frame: Immediately after the intervention
Sleep disturbances after personalized insoles
Time frame: Immediately after the intervention
Sleep disturbances after placebo
Time frame: Immediately after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caffeine supplementation and Personalized insoles in people with Caffeine and Fatigue, run by Universidad de Zaragoza at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agility after fatigue and caffeine supplementation (time frame: One day). The study lists 27 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.