Effect of Different Sex Hormone Profiles for the Response to Physical Training
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Physical training.
- Who it may be relevant to
- Registry conditions: Eumenorrhea, Intrauterine Devices, Medicated, Hormonal Contraception. Basic parameters: 18 years — 35 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The aim of the project is to elucidate the impact of diverse sex hormone profiles on the adaptability of muscle mass to physical training. Additionally, the project aims to investigate secondary effects on adipose tissue, tendons, and other physiological parameters associated with physical function.
Detailed description
The human study is designed as a prospective study where 3 groups with different sex hormonal profiles are followed in parallel in 4 months and tested before, during (2 months) and after 4 months of physical training intervention. The three groups include a control group with regular menstrual bleeding and two groups who have an altered sex hormonal profile due to use of either IUD (containing the progestin levonorgestrel) or mini pills (containing the progestin desogestrel). Before and after the training period the following will be measured/collected: Body composition, Dietary intake, Physical Activity Level, Blood, Urine, Muscle Tissue, Adipose Tissue, Aerobic capacity in bike test, Strength and muscle function tests, and questionnaires about diet and physical activity.
Interventions
- Behavioral Physical training
Aerobic and resistance training three times per week. Two supervised training sessions.
Primary outcome measures
- Muscle mass [Time frame: 4 months]
- Fat free mass [Time frame: 4 months]
Secondary outcome measures (9)
- Muscle fiber type measured by histochemical staining [Time frame: 4 months]
- Protein expression in skeletal muscle tissue [Time frame: 4 months]
- Adipose tissue sex hormone receptors [Time frame: 4 months]
- Resting metabolic rate [Time frame: 4 months]
- Maximal oxygen uptake [Time frame: 4 months]
- Muscle strength [Time frame: 4 months]
- Appetite regulatory markers [Time frame: 4 months]
- Lipid profile [Time frame: 4 months]
- Muscle fiber cross sectional area [Time frame: 4 months]
Eligibility criteria
Inclusion criteria
- BMI 19-25
Exclusion criteria
- Training more than 2 times per week
- Smoking
- Pregnancy
- Taking any medications known to affect the outcome parameters
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
Denmark · 1 center
- Aarhus University, Department for Public Health — Aarhus
Identifiers
NCT: NCT07115849 · 1-10-72-170-24