Significance of Estrogen Status for Muscle Function, Physical Fitness, and Physiological Health Parameters - a Comparison of Age-matched Groups of Women Before and After Menopause. (HER-MUSCLEX)
9 de junio de 2026 actualizado por: Mette Hansen
Effects of Estrogen on Muscle Gain During 12-weeks of Exercise in Post-menopausal Women
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 differences in pre and post menopausal women, in regards to muscle size, strength and function.
Focusing on postmenopausal females, an increasingly at-risk demographic, HER-MUSCLE addresses a critical gap in understanding how oestrogen influences muscle mass and function.
The project involves:
- 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.
- 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
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 differences in pre and post menopausal women, in regards to muscle size, strength and function.
Focusing on postmenopausal females, an increasingly at-risk demographic, HER-MUSCLE addresses a critical gap in understanding how oestrogen influences muscle mass and function.
The project involves:
- 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.
- 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
De observación
Inscripción (Estimado)
30
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
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Aarhus, Dinamarca, 8000
- Reclutamiento
- Aarhus University
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Contacto:
- Mette Hansen, PhD
- Número de teléfono: +4551666551
- Correo electrónico: mhan@ph.au.dk
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Investigador principal:
- Mette Hansen, PhD
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-
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
Método de muestreo
Muestra no probabilística
Población de estudio
Participants will primarily be recruited from a radius of 50km from Aarhus.
Participants recruited will be age matched to participants in the main trial.
Descripción
Inclusion Criteria:
- Regular menstrual bleeding (21-35 days cycle).
- At least 9 menstrual cycles the last year
- Age >47 years old
- BMI 20-30
Exclusion Criteria:
- Only premenopausal women: Follicular stimulating hormone > 30 mmol/L
- Systematic strength training during the last year (> 1 strength training session per week)
- Systematic high intensity cardiovascular training during the last year (<2 times 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
Cohortes e Intervenciones
Grupo / Cohorte |
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Post menopausal women
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Pre menopausal women
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Muscle mass
Periodo de tiempo: 1 week
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Magnetic resonance imaging
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1 week
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Mitochondria Function in vivo measured as phosphocreatine recovery rate
Periodo de tiempo: 1 weeks
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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).
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1 weeks
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Mitochondria Function in vitro measured as maximal oxygen consumption
Periodo de tiempo: 1 weeks
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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.
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1 weeks
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Body composition
Periodo de tiempo: 1 weeks
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DXA
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1 weeks
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Satelitte cells
Periodo de tiempo: 1 weeks
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Histochemical Analysis of Muscle tisse
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1 weeks
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Muscle fiber cross-sectional Area
Periodo de tiempo: 1 weeks
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Histochemical Analysis of Muscle Tissue
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1 weeks
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Expression of Muscle proteins
Periodo de tiempo: 1 weeks
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Western blotting analysis
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1 weeks
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FACS Analysis
Periodo de tiempo: 1 weeks
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FACS analysis to quantify and isolate Muscle satelitte celss, fibro-adipogenic progenitors and macrofages
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1 weeks
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Muscle Strength
Periodo de tiempo: 1 weeks
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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
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1 weeks
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Functional tests
Periodo de tiempo: 1 weeks
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Includes counter-movement jump on a speed force-platform (Swift performance, Australia).
To measure dexterity, the nine-hole peg test will be applied.
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1 weeks
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Cardiovascular fitness
Periodo de tiempo: 1 week
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Vo2max test on a bike and estimated via Ventriject
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1 week
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Maximal fat oxidation rate
Periodo de tiempo: 1 week
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Bike test with increasing intensity steps
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1 week
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Resisting metabolic rate
Periodo de tiempo: 1 week
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1 week
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Questionaires
Periodo de tiempo: 1 week
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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"
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1 week
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Physical Activity Level
Periodo de tiempo: 1 week
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Accelerometers
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1 week
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Flexibility
Periodo de tiempo: 1 week
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sit-and-reach test
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1 week
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Knee laxity
Periodo de tiempo: 1 week
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Lachmeter test
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1 week
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Protein expression in adipose tissue
Periodo de tiempo: 1 week
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Two adipose tissue biopsies will be obtained from each participant by a trained physician.
Western blotting analysis of expression of proteins related to lipolysis and lipogenesis
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1 week
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Blood pressure
Periodo de tiempo: 1 week
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1 week
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Blood volume
Periodo de tiempo: 1 week
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Determination of blood volume and haemoglobin mass by the carbon-monoxide rebreathing method
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1 week
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Blood analysis
Periodo de tiempo: 1 week
|
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-alb
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1 week
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Dairy record registration
Periodo de tiempo: 1 week
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A total of five days prior to the test
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1 week
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Height
Periodo de tiempo: 1 week
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1 week
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Body mass
Periodo de tiempo: 1 week
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1 week
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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
9 de junio de 2026
Publicado por primera vez (Actual)
16 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
16 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
9 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- E30 HER-MUSCLE cross sectional
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. .