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

Not Applicable

Not yet recruiting

• Conditions: Eumenorrhea; Intrauterine Devices, Medicated; Hormonal Contraception

• Registration Number: NCT07115849
• Lead Sponsor: University of Aarhus

Brief Summary

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.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-04
• Study First Submitted QC: 2025-08-04
• Last Update Submitted: 2025-08-04
• Study Start: 2025-08-05
• Study First Posted: 2025-08-11
• Last Update Posted: 2025-08-11
• Primary Completion: 2026-12
• Study Completion: 2028-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Muscle mass	4 months	Muscle mass measured by DXA
Fat free mass	4 months	Fat free mass measured by DXA

Secondary Outcome Measures

Name	Time	Method
Muscle fiber	4	Muscle fiber type and area
Resting metabolic rate	4 months	Resting metabolic rate measured via indirect calorimetry
Protein synthesis and degradation	4 months	Muscle protein synthesis and degradation
Maximal oxygen uptake	4 months	Maximal oxygen uptake
Adipose tissue sex hormone receptors	4 months	Adipose tissue sex hormone receptors
Lipid profile	4 months	Lipid profile
Muscle strength	4 months	Muscle strength (arm and finger strength)
Appetite regulatory markers	4 months	Leptin, Ghrelin, CCK, GLP-1