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
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
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
NCT ID
NCT05028959
First Posted
June 21, 2021
Last Updated
August 30, 2021
Sponsor
Université Paris-Saclay-Assistance publique des hôpitaux de Paris
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
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Hormonal Status, Performance and Health in Elite Female Athlete
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