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 juin 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Estimé)
30
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Mette Hansen, PhD
- Numéro de téléphone: +4551666551
- E-mail: mhan@ph.au.dk
Lieux d'étude
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Aarhus, Danemark, 8000
- Recrutement
- Aarhus University
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Contact:
- Mette Hansen, PhD
- Numéro de téléphone: +4551666551
- E-mail: mhan@ph.au.dk
-
Chercheur principal:
- Mette Hansen, PhD
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
Participants will primarily be recruited from a radius of 50km from Aarhus.
Participants recruited will be age matched to participants in the main trial.
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Post menopausal women
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Pre menopausal women
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Muscle mass
Délai: 1 week
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Magnetic resonance imaging
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1 week
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Mitochondria Function in vivo measured as phosphocreatine recovery rate
Délai: 1 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).
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1 weeks
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Mitochondria Function in vitro measured as maximal oxygen consumption
Délai: 1 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.
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1 weeks
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Body composition
Délai: 1 weeks
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DXA
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1 weeks
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Satelitte cells
Délai: 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
Délai: 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
Délai: 1 weeks
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Western blotting analysis
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1 weeks
|
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FACS Analysis
Délai: 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
Délai: 1 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
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1 weeks
|
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Functional tests
Délai: 1 weeks
|
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
Délai: 1 week
|
Vo2max test on a bike and estimated via Ventriject
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1 week
|
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Maximal fat oxidation rate
Délai: 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
Délai: 1 week
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1 week
|
|
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Questionaires
Délai: 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
Délai: 1 week
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Accelerometers
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1 week
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Flexibility
Délai: 1 week
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sit-and-reach test
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1 week
|
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Knee laxity
Délai: 1 week
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Lachmeter test
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1 week
|
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Protein expression in adipose tissue
Délai: 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
Délai: 1 week
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1 week
|
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Blood volume
Délai: 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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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Blood analysis
Délai: 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
Délai: 1 week
|
A total of five days prior to the test
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1 week
|
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Height
Délai: 1 week
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1 week
|
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Body mass
Délai: 1 week
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1 week
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Mette Hansen, PhD, Aarhus University, Department of Public Health
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Liens utiles
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 février 2026
Achèvement primaire (Estimé)
1 août 2027
Achèvement de l'étude (Estimé)
1 août 2027
Dates d'inscription aux études
Première soumission
27 février 2026
Première soumission répondant aux critères de contrôle qualité
9 juin 2026
Première publication (Réel)
16 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
16 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
9 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- E30 HER-MUSCLE cross sectional
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
Do to GDPR rules, we do not plan to share
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .