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Effects of Estrogen on Muscle Gain During 12-weeks of Exercise in Post-menopausal Women (HER-MUSCLE)

23 de mayo de 2026 actualizado por: Mette Hansen

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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

30

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Mette Hansen, PhD
  • Número de teléfono: +4551666551
  • Correo electrónico: mhan@ph.au.dk

Ubicaciones de estudio

  • Dinamarca
    • Jutland
      • Aarhus, Jutland, Dinamarca, 8000
        • Reclutamiento
        • Aarhus University
        • Contacto:
          • Mette Hansen, PhD
          • Número de teléfono: +4551666551
          • Correo electrónico: mhan@ph.au.dk

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Ciencia básica
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Estrogen
Transdermal Estrogen Administration
Droga: Estrogel
The other group receive placebo treatment
Conductual: Physical exercise
Both groups will go through 12 weeks of supervised physical exercise, consisting of both strength training and cardiovascular training
Comparador de placebos: Placebo
Transdermal placebo administration
Conductual: Physical exercise
Both groups will go through 12 weeks of supervised physical exercise, consisting of both strength training and cardiovascular training

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Muscle mass
Periodo de tiempo: 12 weeks
Magnetic resonance imaging of one leg before and after intervention
12 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Presión sanguínea
Periodo de tiempo: 12 semanas
12 semanas
Mitochondria Function in vivo measured as phosphocreatine recovery rate
Periodo de tiempo: 12 weeks
The dominant foot will be attached to a pedal mounted on the patient bed and a dedicated 31P surface coil will be secured over the tibialis anterior muscle. The pedal is designed to allow dynamic contractions of the tibialis anterior muscle while changes in metabolites from the tibialis anterior muscle are acquired non-invasively with the 31P coil. Two protocols will be performed: Firstly, 10 repeated contractions (one per 3 sec with a load representing 30% of maximal force) will result in a depletion (30-40%) of phosphocreatine (PCr). The rate constant for PCr recovery over 10 min will be used as an index of in vivo mitochondrial function. Secondly, a total of 80 repeated contractions (one per 3 sec with a load representing 30% of maximal force) will be used to quantify muscle fatigue and concurrent changes in muscle metabolites and intracellular pH (based on the chemical shift between inorganic phosphate and PCr).
12 weeks
Mitochondria Function in vitro measured as maximal oxygen consumption
Periodo de tiempo: 12 weeks

All measurements were performed in duplicate using an Oxygraph-2k (Oroboros, Austria), in hyperoxygenated chambers (250-450 nmol O₂/mL).

Respiratory Control Ratio was used to evaluate mitochondrial efficiency. It was calculated as the ratio of maximal ADP-supported respiration (with complex I + II substrates) to leak respiration. Leak respiration reflects oxygen consumption in the absence of ATP synthesis, when only substrates are present and no ADP is added.
12 weeks
Body composition
Periodo de tiempo: 12 weeks
DXA
12 weeks
Satelitte cells
Periodo de tiempo: 12 weeks
Histochemical Analysis of Muscle tisse
12 weeks
Muscle fiber cross-sectional Area
Periodo de tiempo: 12 weeks
Histochemical Analysis of Muscle Tissue
12 weeks
Expression of Muscle proteins
Periodo de tiempo: 12 weeks
Western blotting analysis
12 weeks
FACS Analysis
Periodo de tiempo: 12 weeks
FACS analysis to quantify and isolate Muscle satelitte celss, fibro-adipogenic progenitors and macrofages
12 weeks
Muscle Strength
Periodo de tiempo: 12 weeks
Includes measure of leg strength during isometric and dynamic maximal voluntary contractions in a dynamometer (Humac Norm, CSMi, Massachusetts, United States) with a hip angle of 90°. In addition, finger strength, hand grip strength
12 weeks
Functional test
Periodo de tiempo: 12 weeks
Includes counter-movement jump on a speed force-platform (Swift performance, Australia). To measure dexterity, the nine-hole peg test will be applied.
12 weeks
Cardiovascular fitness
Periodo de tiempo: 12 weeks
Vo2max test on a bike and estimated via Ventriject
12 weeks
Maximal fat oxidation rate
Periodo de tiempo: 12 weeks
Bike test with increasing intensity steps
12 weeks
Resisting metabolic rate
Periodo de tiempo: 12 weeks
12 weeks
Questionaires
Periodo de tiempo: 12 weeks
The participant will be asked to fill out recognized questionnaires about menopause (Menopause Rating Scale), sleep, diet and training readiness (modified version of "The wellbeing review"
12 weeks
Physical Activity Level
Periodo de tiempo: 12 weeks
Accelerometers
12 weeks
Flexibility
Periodo de tiempo: 12 weeks
sit-and-reach test
12 weeks
Knee laxity
Periodo de tiempo: 12 weeks
Lachmeter test
12 weeks
Protein expression in adipose tissue
Periodo de tiempo: 12 weeks
Two adipose tissue biopsies will be obtained from each participant by a trained physician before and after 12 weeks from subcutaneous abdominal and gluteal regions. Western blotting analysis of expression of proteins related to lipolysis and lipogenesis
12 weeks
Blood volume
Periodo de tiempo: 12 weeks
Determination of blood volume and haemoglobin mass by the carbon-monoxide rebreathing method
12 weeks

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Altura
Periodo de tiempo: 12 semanas
12 semanas
Blood analysis
Periodo de tiempo: 12 weeks
estradiol testosteron SHBG progesteron FSH LH Insulin IGF-1 + IGF-1 Bp3 - metabolit LDL - lipid HDL - lipid Triglycerid - lipid Total cholesterol Kortisol P1NP CTX1 - knogle HbA1c PTH CRP p-kreatinase p-kreatinin+eGFR p-calcium p-alanintransaminase p-albumin Alkalisk fosfatase (ALP) 6-keto-PGF1a Endothelin-1 s-VCAM-1 s-ICAM-1 Glucose Hæmoglobin Hæmatokrit
12 weeks
Dairy record registration
Periodo de tiempo: 12 weeks
Before the intervention and during during rehabilization
12 weeks
Body mass
Periodo de tiempo: 12 weeks
12 weeks

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Mette Hansen

Colaboradores

Aarhus University Hospital
University of Copenhagen
Aalborg University

Investigadores

  • Investigador principal: Mette Hansen, PhD, Aarhus University, Department of Public Health

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de febrero de 2026

Finalización primaria (Estimado)

1 de agosto de 2027

Finalización del estudio (Estimado)

1 de agosto de 2027

Fechas de registro del estudio

Enviado por primera vez

27 de febrero de 2026

Primero enviado que cumplió con los criterios de control de calidad

23 de mayo de 2026

Publicado por primera vez (Actual)

1 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

1 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

23 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • E30 HER-MUSCLE Intervention

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Do to GDPR rules, we do not plan to share

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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