Accuracy of Anthropometric Equations to Estimate DXA-Deri... | NCT03884010

Studies
Accuracy of Anthropometric Equations to Estimate DXA-Derived Skeletal Muscle Mass in Professional Male Soccer Players

NCT03884010

Sponsor

Centro Universitario de Ciencias de la Salud, Mexico

Status

Completed

Last Update Posted

Aug 30, 2023Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Body Composition

Interventions

No intervention

Countries

Mexico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2009Actual

Primary Completion Date

Dec 2017Actual

Completion Date

Jan 2018Actual

First Submitted Date

Mar 19, 2019

First Submission Date that Met QC Criteria

Mar 19, 2019

First Posted Date

Mar 21, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 29, 2023

Last Update Posted Date

Aug 30, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Juan Ricardo Lopez y Taylor, Director of the Institute of Applied Sciences for Physical Activity and Sport, Centro Universitario de Ciencias de la Salud, MexicoPrincipal Investigator

Lead Sponsor

Centro Universitario de Ciencias de la Salud, MexicoOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aimed to analyze the accuracy of different anthropometric equations to estimate skeletal muscle mass in professional male soccer players, setting dual-energy x-ray absorptiometry (DXA) skeletal muscle mass as the reference.

Detailed Description

The study consisted of evaluating anthropometric measurements and body composition with DXA in professional male soccer player aged 18 years and older. Standardized and certified personnel carried out anthropometric measurements and DXA whole body scan the same day.

Skeletal muscle mass was estimated with several anthropometric equations. The reference skeletal muscle mass was obtained assessing appendicular lean soft tissue from a whole-body DXA scan and then transformed into skeletal muscle mass with Kim equation (2002).

The estimated skeletal muscle mass from anthropometric equations was compared with DXA, and those with non-significant differences were further analyzed for calculating mean differences and 95% limits of agreement with DXA. This analysis was carried out for all equations.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Participants		Professional male soccer players from the second professional Mexican division	Other: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	Cross-sectional	Participants

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Skeletal muscle mass	Skeletal muscle mass was obtained from assessing appendicular lean soft tissue from a DXA whole body scan, and then transformed into skeletal muscle mass with Kim equation (2002).	One day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed contract with the team

Exclusion Criteria:

Injured

Accepts Healthy Volunteers

Not provided

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

37 Years

Standard Ages

Adult

Study Population

Professional male soccer players hired into a second professional Mexican division team.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Juan R López-Taylor	University of Guadalajara	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Instituto de Ciencias Aplicadas a la Actividad Física y al Deporte		Guadalajara	Jalisco	44430	Mexico

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided