Effect of Caffeine Supplementation and Personalized Insoles on Females

May 6, 2024 updated by: Alejandro Gómez Bruton, Universidad de Zaragoza

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Alejandro Gómez Bruton, PhD
  • Phone Number: +34876553755
  • Email: bruton@unizar.es

Study Contact Backup

  • Name: Gabriel Lozano Berges, PhD
  • Phone Number: +34876553755
  • Email: glozano@unizar.es

Study Locations

  • Spain
      • Zaragoza, Spain, 50012
        • Universidad de Zaragoza

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Females
  • Soccer players who have been competing for at least 3 years

Exclusion Criteria:

  • Participants with major injuries in the lower limbs within the 12 months before testing.
  • Participants consuming ephedrine or related medicines

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Personalized insoles
Personalized insoles without supplementation
Device: Personalized insoles
Participants will wear personalized insoles and ingest a drink of carbohydrates without caffeine
Experimental: Caffeine supplementation
Standard insoles with caffeine supplementation (3mg/kg)
Dietary supplement: Caffeine supplementation
Participants will wear standard insoles and ingest caffeine in liquid form (3mg/kg) with carbohydrates.
Placebo Comparator: Control condition
Standard insoles without supplementation
Other: Control condition
Participants will wear standard insoles and ingest a drink of carbohydrates without caffeine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
One day
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.
One day
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.
One day
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.
One day
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.
One day
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.
One day
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.
One day
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.
One day
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.
One day
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.
During the intervention
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.
During the intervention
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.
During the intervention
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.
During the intervention
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.
During the intervention
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.
During the intervention
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.
During the intervention
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.
During the intervention
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.
During the intervention
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.
During the intervention
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.
During the intervention
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.
During the intervention
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.
During the intervention
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.
During the intervention
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.
During the intervention
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.
During the intervention
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.
During the intervention
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.
During the intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Injury incidence
Time Frame: Six months
Association between the primary outcomes and injury incidence registered through the International Federation of Association Football questionnaire (F-MARC)
Six months
Sleep disturbances after caffeine ingestion
Time Frame: Immediately after the intervention
Rate of patients with sleep problems assessed with the Athens sleep questionnaire
Immediately after the intervention
Sleep disturbances after personalized insoles
Time Frame: Immediately after the intervention
Rate of patients with sleep problems assessed with the Athens sleep questionnaire
Immediately after the intervention
Sleep disturbances after placebo
Time Frame: Immediately after the intervention
Rate of patients with sleep problems assessed with the Athens sleep questionnaire
Immediately after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad de Zaragoza

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 9, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 6, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 24, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UZCUD2020-BIO-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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