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NCT Number: NCT07115849

Effect of Different Sex Hormone Profiles for the Response to Physical Training

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.

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University, Department for Public Health

Aarhus, Jutland, 8000, Denmark

Location status: Recruiting

Location contact

Mette Hansen, PhD

CONTACT

[email protected]

+4551666551

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

physical training

Behavioral

Aerobic and resistance training three times per week. Two supervised training sessions.

Primary outcomes

  1. Muscle mass

    Time frame: 4 months

    Muscle mass measured by DXA

  2. Fat free mass

    Time frame: 4 months

    Fat free mass measured by DXA

Secondary outcomes

  1. Muscle fiber type measured by histochemical staining

    Time frame: 4 months

    Muscle fiber type measured by histochemical staining

  2. Protein expression in skeletal muscle tissue

    Time frame: 4 months

    Expression of Muscle protein signaling markers for muscle protein degradation and synthesis pathways

  3. Adipose tissue sex hormone receptors

    Time frame: 4 months

    Adipose tissue sex hormone receptors

  4. Resting metabolic rate

    Time frame: 4 months

    Resting metabolic rate measured via indirect calorimetry

  5. Maximal oxygen uptake

    Time frame: 4 months

    Maximal oxygen uptake

  6. Muscle strength

    Time frame: 4 months

    Muscle strength (arm and finger strength)

  7. Appetite regulatory markers

    Time frame: 4 months

    Leptin, Ghrelin, CCK, GLP-1

  8. Lipid profile

    Time frame: 4 months

    Lipid profile

  9. Muscle fiber cross sectional area

    Time frame: 4 months

    Muscle fiber cross sectional area measured by histochemical stainings

Study contacts

Contact information is provided by the study sponsor or research team.

Mette Hansen, PhD

CONTACT

[email protected]

+4551666551

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Aug 11, 2025
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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