Effects of Estrogen on Muscle Gain During 12-weeks of Exercise in Post-menopausal Women (HER-MUSCLE)
23 de maio de 2026 atualizado 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:
- 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.
- 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.
Visão geral do estudo
Status
Recrutamento
Intervenção / Tratamento
Descrição detalhada
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:
- 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.
- 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 estudo
Intervencional
Inscrição (Estimado)
30
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Mette Hansen, PhD
- Número de telefone: +4551666551
- E-mail: mhan@ph.au.dk
Locais de estudo
-
-
Jutland
-
Aarhus, Jutland, Dinamarca, 8000
- Recrutamento
- Aarhus University
-
Contato:
- Mette Hansen, PhD
- Número de telefone: +4551666551
- E-mail: mhan@ph.au.dk
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Sim
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Estrogen
Transdermal Estrogen Administration
|
The other group receive placebo treatment
Both groups will go through 12 weeks of supervised physical exercise, consisting of both strength training and cardiovascular training
|
|
Comparador de Placebo: Placebo
Transdermal placebo administration
|
Both groups will go through 12 weeks of supervised physical exercise, consisting of both strength training and cardiovascular training
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Muscle mass
Prazo: 12 weeks
|
Magnetic resonance imaging of one leg before and after intervention
|
12 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Pressão sanguínea
Prazo: 12 semanas
|
12 semanas
|
|
|
Mitochondria Function in vivo measured as phosphocreatine recovery rate
Prazo: 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
Prazo: 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
Prazo: 12 weeks
|
DXA
|
12 weeks
|
|
Satelitte cells
Prazo: 12 weeks
|
Histochemical Analysis of Muscle tisse
|
12 weeks
|
|
Muscle fiber cross-sectional Area
Prazo: 12 weeks
|
Histochemical Analysis of Muscle Tissue
|
12 weeks
|
|
Expression of Muscle proteins
Prazo: 12 weeks
|
Western blotting analysis
|
12 weeks
|
|
FACS Analysis
Prazo: 12 weeks
|
FACS analysis to quantify and isolate Muscle satelitte celss, fibro-adipogenic progenitors and macrofages
|
12 weeks
|
|
Muscle Strength
Prazo: 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
Prazo: 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
Prazo: 12 weeks
|
Vo2max test on a bike and estimated via Ventriject
|
12 weeks
|
|
Maximal fat oxidation rate
Prazo: 12 weeks
|
Bike test with increasing intensity steps
|
12 weeks
|
|
Resisting metabolic rate
Prazo: 12 weeks
|
12 weeks
|
|
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Questionaires
Prazo: 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
Prazo: 12 weeks
|
Accelerometers
|
12 weeks
|
|
Flexibility
Prazo: 12 weeks
|
sit-and-reach test
|
12 weeks
|
|
Knee laxity
Prazo: 12 weeks
|
Lachmeter test
|
12 weeks
|
|
Protein expression in adipose tissue
Prazo: 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
Prazo: 12 weeks
|
Determination of blood volume and haemoglobin mass by the carbon-monoxide rebreathing method
|
12 weeks
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Altura
Prazo: 12 semanas
|
12 semanas
|
|
|
Blood analysis
Prazo: 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
Prazo: 12 weeks
|
Before the intervention and during during rehabilization
|
12 weeks
|
|
Body mass
Prazo: 12 weeks
|
12 weeks
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Mette Hansen, PhD, Aarhus University, Department of Public Health
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Links úteis
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de fevereiro de 2026
Conclusão Primária (Estimado)
1 de agosto de 2027
Conclusão do estudo (Estimado)
1 de agosto de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
27 de fevereiro de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
23 de maio de 2026
Primeira postagem (Real)
1 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
1 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
23 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Comportamento
- Atividade motora
- Hormônios
- Hormônios, substitutos hormonais e antagonistas hormonais
- Atividade motora
- Movimento
- Fenômenos fisiológicos musculoesqueléticos
- Fenômenos fisiológicos musculoesqueléticos e neurais
- Compostos policíclicos
- Esteróides
- Compostos de anel fundido
- Estrenos
- Estranes
- Congêneros de estradiol
- Hormônios esteróides gonadais
- Hormônios gonadais
- Estradiol
- Exercício
Outros números de identificação do estudo
- E30 HER-MUSCLE Intervention
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
Do to GDPR rules, we do not plan to share
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .