Effect of Caffeine Supplementation and Personalized Insoles on Females

NCT ID: NCT04642131

Last Updated: 2024-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-09

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Caffeine Fatigue Injuries Females Xy Soccer Biomechanical Parameters

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators
Participants will be given a bottle with either caffeine and carbohydrates or just carbohydrates.

Study Groups

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Personalized insoles

Personalized insoles without supplementation

Group Type EXPERIMENTAL

Personalized insoles

Intervention Type DEVICE

Participants will wear personalized insoles and ingest a drink of carbohydrates without caffeine

Caffeine supplementation

Standard insoles with caffeine supplementation (3mg/kg)

Group Type EXPERIMENTAL

Caffeine supplementation

Intervention Type DIETARY_SUPPLEMENT

Participants will wear standard insoles and ingest caffeine in liquid form (3mg/kg) with carbohydrates.

Control condition

Standard insoles without supplementation

Group Type PLACEBO_COMPARATOR

Control condition

Intervention Type OTHER

Participants will wear standard insoles and ingest a drink of carbohydrates without caffeine

Interventions

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Caffeine supplementation

Participants will wear standard insoles and ingest caffeine in liquid form (3mg/kg) with carbohydrates.

Intervention Type DIETARY_SUPPLEMENT

Personalized insoles

Participants will wear personalized insoles and ingest a drink of carbohydrates without caffeine

Intervention Type DEVICE

Control condition

Participants will wear standard insoles and ingest a drink of carbohydrates without caffeine

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad de Zaragoza

OTHER

Sponsor Role lead

Responsible Party

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Alejandro Gómez Bruton

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universidad de Zaragoza

Zaragoza, , Spain

Site Status

Countries

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Spain

Other Identifiers

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UZCUD2020-BIO-02

Identifier Type: -

Identifier Source: org_study_id

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