Effects of Estrogen on Muscle Gain During 12-weeks of Exercise in Post-menopausal Women

Overview

As females age and transition through menopause, the decline in oestrogen level profoundly affects skeletal muscle mass and function. HER-MUSCLE aims to unravel the mechanisms by which oestrogen enhances muscle growth, providing insights for targeted therapies to improve the health and physical function of postmenopausal females. Focusing on postmenopausal females, an increasingly at-risk demographic, HER-MUSCLE addresses a critical gap in understanding how oestrogen influences muscle mass and function during anabolic (exercise) conditions. The project involves: 1. Clinical Trial: Postmenopausal females will receive either oestrogen or placebo, twelve weeks of exercise training to detect oestrogen regulatory role on muscle mass and function. 2. Molecular Analysis: Advanced techniques will study the muscle microenvironment, focusing on muscle stem cells (MuSCs), fibro-adipogenic progenitors (FAPs), and other cells critical for muscle regeneration and maintenance. 3. Mitochondrial Function assessed in vivo via magnetic resonance spectroscopy: The impact of oestrogen on mitochondrial health will be examined, exploring how it preserves mitochondrial function and ability to recovery and resist fatigue in response to muscle contractions. Our preliminary data indicate that oestrogen can promote muscle protein synthesis. HER-MUSCLE aims to pave the way for novel therapeutic strategies to manage sarcopenia in postmenopausal women, ultimately leading to better health outcomes and enhanced well-being for this growing population segment.

Detailed description

As females age and transition through menopause, the decline in oestrogen level profoundly affects skeletal muscle mass and function. HER-MUSCLE aims to unravel the mechanisms by which oestrogen enhances muscle growth, providing insights for targeted therapies to improve the health and physical function of postmenopausal females.

Focusing on postmenopausal females, an increasingly at-risk demographic, HER-MUSCLE addresses a critical gap in understanding how oestrogen influences muscle mass and function during anabolic (exercise) conditions.

The project involves:

1. Clinical Trial: Postmenopausal females will receive either oestrogen or placebo, twelve weeks of exercise training to detect oestrogen regulatory role on muscle mass and function. 2. Molecular Analysis: Advanced techniques will study the muscle microenvironment, focusing on muscle stem cells (MuSCs), fibro-adipogenic progenitors (FAPs), and other cells critical for muscle regeneration and maintenance. 3. Mitochondrial Function assessed in vivo via magnetic resonance spectroscopy: The impact of oestrogen on mitochondrial health will be examined, exploring how it preserves mitochondrial function and ability to recovery and resist fatigue in response to muscle contractions.

Our preliminary data indicate that oestrogen can promote muscle protein synthesis. HER-MUSCLE aims to pave the way for novel therapeutic strategies to manage sarcopenia in postmenopausal women, ultimately leading to better health outcomes and enhanced well-being for this growing population segment.

Interventions

• Drug Estrogel
  The other group receive placebo treatment
• Behavioral Physical exercise
  Both groups will go through 12 weeks of supervised physical exercise, consisting of both strength training and cardiovascular training

Primary outcome measures

• Muscle mass [Time frame: 12 weeks]

Secondary outcome measures (12)

• Mitochondria Function in vivo measured as phosphocreatine recovery rate [Time frame: 12 weeks]
• Mitochondria Function in vitro measured as maximal oxygen consumption [Time frame: 12 weeks]
• Body composition [Time frame: 12 weeks]
• Satelitte cells [Time frame: 12 weeks]
• Muscle fiber cross-sectional Area [Time frame: 12 weeks]
• Expression of Muscle proteins [Time frame: 12 weeks]
• FACS Analysis [Time frame: 12 weeks]
• Muscle Strength [Time frame: 12 weeks]
• Functional test [Time frame: 12 weeks]
• Cardiovascular fitness [Time frame: 12 weeks]
• Maximal fat oxidation rate [Time frame: 12 weeks]
• Resisting metabolic rate [Time frame: 12 weeks]

Eligibility criteria

Inclusion criteria

• 1-10 years since last menstrual bleeding
• Age > 40 years old
• BMI 20-30

Exclusion criteria

• Follicular stimulating hormone < 30 mmol/L
• Systematic strength training during the last year (> 1 strength training session per week)
• Injuries to the legs which may prevent participation in the physical training program
• Magnetizable metals or electrical devices implanted in the body, such as a pacemaker
• Use of medication that can influence the effect of immobilization and/or training
• Muscular or joint disorders which may affect the results
• Metabolic diseases (such as diabetes and cardiovascular diseases)
• Previous or present liver or cancer disease
• Current or previous thrombosis
• Porphyria
• Epilepsia
• Systemic autoimmune disease
• Edema
• Smoking or use of other nicotine containing products
• Claustrophobia
• Addictive behavior, defined as abuse of cannabis, opioids, or other intoxicating substances.
• Lack of ability to cooperate
• Blood parameters out of normal range at the health check
• Blood pressure above 140/90 mmHg

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Basic science

Study locations

Denmark · 1 center

• Aarhus University — Aarhus

Identifiers

NCT: NCT07617454 · E30 HER-MUSCLE Intervention

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗