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Hormonal Status, Performance and Health in Elite Female Athlete (FEMMES)

Primary Purpose

Healthy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Multidisciplinary monitoring of healthy women
Sponsored by
Université Paris-Saclay-Assistance publique des hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Healthy focused on measuring female elite athlete, menstrual phase, amenorrhea, hormonal contraception, performance, health, Athlete Biological Passport

Eligibility Criteria

16 Years - 30 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Group 1: high-level athletes (qualified for national/international championships and/or training at least 15 hours/week)
  • Group 2: recreational athletes who practice a regular physical activity

Exclusion Criteria:

  • Participation in another trial
  • History of cardiac pathology
  • High blood pressure
  • History of ulcers and other gastrointestinal disorders
  • Myasthenia
  • Renal insufficiency
  • Person not affiliated or not benefiting from a social security system

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Female athletes

    Leisure sport women

    Arm Description

    highly trained subjects

    recreational sportswomen practicing regular physical activity

    Outcomes

    Primary Outcome Measures

    Change from baseline weight
    in kg, by impedancemeter
    Change from baseline fat and lean mass
    in kg, by impedancemeter
    Change from baseline height
    in cm, by height gauge
    Change from baseline sex and stress hormones
    concentration of oestradiol, progesterone, testosterone, DHEA, cortisol, LH and FSH in mol/L
    Change from baseline food intake
    food intake questionnaire to complete over 3 days, expressed in kcal/day
    Change from baseline metabolic parameters
    concentration of blood glucose, blood lactate, lipid profile, insulin, GH, IGF1, T3, IgA, PRL and leptin in mol/L
    Change from baseline respiratory parameters
    measure of FEV1 (forced expiratory volume in 1 second), expressed in % of vital capacity
    Change from baseline inflammatory parameters
    concentration of cytokines (TNF-alpha, IL-6) in mol/L
    Change from baseline executive function
    assessed by instability via static and dynamic postures (eyes open/closed) on platform
    Change from baseline visual-spatial processing
    3 D mental rotation test, assessed by scores: range from 0 - 24, with 24 representing a perfect total score
    Change from baseline attention and working memory
    Stroop Color Word Task, assessed by scores : range of interference from -15 - +15, with higher scores representing decreased selective attention
    Change from baseline performance monitoring
    field performance test, performance expressed in time
    Change from baseline Athlete Biological Passport (Group 2)
    assessed by analysis of the standardized parameters of the Athlete Biological Passport (WADA)
    Change from baseline affects (Group 2)
    Positive Affect and Negative Affect Schedule (PANAS), assessed by scores. Positive Affect Score: range from 10 - 50, with higher scores representing higher levels of positive affect. Negative Affect Score: range from 10 - 50, with lower scores representing lower levels of negative affect.
    Change from baseline anxiety (Group 2)
    Spielberger State-Trait Anxiety Inventory, assessed by scores: range from 20 - 80, with higher scores representing higher anxiety
    Change from baseline Athlete Biological Passport (Group 1)
    assessed by analysis of the standardized parameters of the Athlete Biological Passport (WADA)
    Change from baseline affects (Group 1)
    Positive Affect and Negative Affect Schedule (PANAS), assessed by scores. Positive Affect Score: range from 10 - 50, with higher scores representing higher levels of positive affect. Negative Affect Score: range from 10 - 50, with lower scores representing lower levels of negative affect.
    Change from baseline anxiety (Group 1)
    Spielberger State-Trait Anxiety Inventory, assessed by scores: range from 20 - 80, with higher scores representing higher anxiety
    Interview (Group 1)
    Self-confrontation interview for questioning the action

    Secondary Outcome Measures

    Full Information

    First Posted
    June 21, 2021
    Last Updated
    August 30, 2021
    Sponsor
    Université Paris-Saclay-Assistance publique des hôpitaux de Paris
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05028959
    Brief Title
    Hormonal Status, Performance and Health in Elite Female Athlete
    Acronym
    FEMMES
    Official Title
    Menstrual Cycle, Amenorrhea and Contraception in Elite Female Athletes: Impact on Performance, Health and the Athlete's Biological Passport
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 15, 2021 (Anticipated)
    Primary Completion Date
    May 31, 2023 (Anticipated)
    Study Completion Date
    May 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Université Paris-Saclay-Assistance publique des hôpitaux de Paris

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The repercussions of the hormonal status of high-level sportswomen on their performance and health as well as on the Athlete's Biological Passport (ABP) have been little studied and remain poorly known. The investigators therefore propose to contribute to the improvement of current knowledge by determining, thanks to the implementation of a multidisciplinary monitoring, with the use of various tests and matrices, in female elite athletes and recreational athletes (control group): 1) the impact of cycle phase, absence of cycle or contraceptive use on physical and psychological performance, health as well as on ABP; 2) the potential confounding effects of the athlete's environment 3) correlations between the different matrices analyzed
    Detailed Description
    Volunteers to be studied: 80 healthy female subjects (16 to 30 years old), divided into 2 groups: Group 1: 60 athletes, from different sports disciplines, in amenorrhea, with menstrual cycle or taking contraceptives Group 2: 20 leisure sports subjects with menstrual cycle or taking contraceptives Following the oral and written information of the project, the subjects have a minimum of 15 days of reflection before signing the written consent form. They will have the possibility, at any time, to voluntarily interrupt the study without having to justify themselves. Investigations to be performed: Annual complete clinical examination : "Out-of-competition" follow-up, time frame 6 months medical, nutritional and respiratory monitoring biological monitoring psychological monitoring performance monitoring Non-invasive "in-competition" monitoring, only for Group 1, once in a year on the day before/after a major competition: biological monitoring psychological monitoring performance monitoring (interview)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Healthy
    Keywords
    female elite athlete, menstrual phase, amenorrhea, hormonal contraception, performance, health, Athlete Biological Passport

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    2 groups : female athletes and leisure sports women
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Female athletes
    Arm Type
    Experimental
    Arm Description
    highly trained subjects
    Arm Title
    Leisure sport women
    Arm Type
    Experimental
    Arm Description
    recreational sportswomen practicing regular physical activity
    Intervention Type
    Other
    Intervention Name(s)
    Multidisciplinary monitoring of healthy women
    Intervention Description
    Multidisciplinary monitoring
    Primary Outcome Measure Information:
    Title
    Change from baseline weight
    Description
    in kg, by impedancemeter
    Time Frame
    6 months
    Title
    Change from baseline fat and lean mass
    Description
    in kg, by impedancemeter
    Time Frame
    6 months
    Title
    Change from baseline height
    Description
    in cm, by height gauge
    Time Frame
    6 months
    Title
    Change from baseline sex and stress hormones
    Description
    concentration of oestradiol, progesterone, testosterone, DHEA, cortisol, LH and FSH in mol/L
    Time Frame
    6 months
    Title
    Change from baseline food intake
    Description
    food intake questionnaire to complete over 3 days, expressed in kcal/day
    Time Frame
    6 months
    Title
    Change from baseline metabolic parameters
    Description
    concentration of blood glucose, blood lactate, lipid profile, insulin, GH, IGF1, T3, IgA, PRL and leptin in mol/L
    Time Frame
    6 months
    Title
    Change from baseline respiratory parameters
    Description
    measure of FEV1 (forced expiratory volume in 1 second), expressed in % of vital capacity
    Time Frame
    6 months
    Title
    Change from baseline inflammatory parameters
    Description
    concentration of cytokines (TNF-alpha, IL-6) in mol/L
    Time Frame
    6 months
    Title
    Change from baseline executive function
    Description
    assessed by instability via static and dynamic postures (eyes open/closed) on platform
    Time Frame
    6 months
    Title
    Change from baseline visual-spatial processing
    Description
    3 D mental rotation test, assessed by scores: range from 0 - 24, with 24 representing a perfect total score
    Time Frame
    6 months
    Title
    Change from baseline attention and working memory
    Description
    Stroop Color Word Task, assessed by scores : range of interference from -15 - +15, with higher scores representing decreased selective attention
    Time Frame
    6 months
    Title
    Change from baseline performance monitoring
    Description
    field performance test, performance expressed in time
    Time Frame
    6 months
    Title
    Change from baseline Athlete Biological Passport (Group 2)
    Description
    assessed by analysis of the standardized parameters of the Athlete Biological Passport (WADA)
    Time Frame
    6 months
    Title
    Change from baseline affects (Group 2)
    Description
    Positive Affect and Negative Affect Schedule (PANAS), assessed by scores. Positive Affect Score: range from 10 - 50, with higher scores representing higher levels of positive affect. Negative Affect Score: range from 10 - 50, with lower scores representing lower levels of negative affect.
    Time Frame
    6 months
    Title
    Change from baseline anxiety (Group 2)
    Description
    Spielberger State-Trait Anxiety Inventory, assessed by scores: range from 20 - 80, with higher scores representing higher anxiety
    Time Frame
    6 months
    Title
    Change from baseline Athlete Biological Passport (Group 1)
    Description
    assessed by analysis of the standardized parameters of the Athlete Biological Passport (WADA)
    Time Frame
    8 months
    Title
    Change from baseline affects (Group 1)
    Description
    Positive Affect and Negative Affect Schedule (PANAS), assessed by scores. Positive Affect Score: range from 10 - 50, with higher scores representing higher levels of positive affect. Negative Affect Score: range from 10 - 50, with lower scores representing lower levels of negative affect.
    Time Frame
    8 months
    Title
    Change from baseline anxiety (Group 1)
    Description
    Spielberger State-Trait Anxiety Inventory, assessed by scores: range from 20 - 80, with higher scores representing higher anxiety
    Time Frame
    8 months
    Title
    Interview (Group 1)
    Description
    Self-confrontation interview for questioning the action
    Time Frame
    8 months

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Female
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Group 1: high-level athletes (qualified for national/international championships and/or training at least 15 hours/week) Group 2: recreational athletes who practice a regular physical activity Exclusion Criteria: Participation in another trial History of cardiac pathology High blood pressure History of ulcers and other gastrointestinal disorders Myasthenia Renal insufficiency Person not affiliated or not benefiting from a social security system
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Emmanuelle DURON, PU-PH
    Phone
    33144083503
    Email
    emmanuelle.duron@aphp.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Christine Le-Scanff, PU
    Phone
    33169156198
    Email
    christine.le-scanff@universite-paris-saclay.fr

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
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    30301734
    Citation
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    Hormonal Status, Performance and Health in Elite Female Athlete

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