Effect of Caffeine Supplementation and Personalized Insoles on Females

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: Recruiting
• Conditions: Fatigue; Injuries; Caffeine; Soccer; Females Xy; Biomechanical Parameters
• Intervention / Treatment: Device: Personalized insoles; Dietary supplement: Caffeine supplementation; Other: Control condition

• Study Type: Interventional
• Enrollment (Anticipated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: 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
    • Recruiting
    • Universidad de Zaragoza
    • Contact: Gabriel Lozano Berges, PhD; Email: glozano@unizar.es
    • Contact: Alejandro Gomez Bruton, PhD; Email: bruton@unizar.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

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

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	During the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Injury incidence	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	Rate of patients with sleep problems assessed with the Athens sleep questionnaire	Immediately after the intervention
Sleep disturbances after personalized insoles	Rate of patients with sleep problems assessed with the Athens sleep questionnaire	Immediately after the intervention
Sleep disturbances after placebo	Rate of patients with sleep problems assessed with the Athens sleep questionnaire	Immediately after the intervention

Collaborators and Investigators

• Sponsor: Universidad de Zaragoza

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 9, 2020
• Primary Completion (ANTICIPATED): July 1, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: November 6, 2020
• First Submitted That Met QC Criteria: November 18, 2020
• First Posted (ACTUAL): November 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 28, 2022
• Last Update Submitted That Met QC Criteria: November 25, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: performance; women; insoles; kinematics; kinetics; athletics; team sport
• Additional Relevant MeSH Terms: Fatigue; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Purinergic Antagonists; Purinergic Agents; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Central Nervous System Stimulants; Caffeine
• Other Study ID 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