Aarhus University
Aarhus, Jutland, 8000, Denmark
Location status: Recruiting
NCT Number: NCT07617454
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.
Interested in participating?
Request Info40 year and older
Female
Interventional
Not applicable
Aarhus, Jutland, 8000, Denmark
Location status: Recruiting
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:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 12 weeks
Magnetic resonance imaging of one leg before and after intervention
Time frame: 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).
Time frame: 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.
Time frame: 12 weeks
DXA
Time frame: 12 weeks
Histochemical Analysis of Muscle tisse
Time frame: 12 weeks
Histochemical Analysis of Muscle Tissue
Time frame: 12 weeks
Western blotting analysis
Time frame: 12 weeks
FACS analysis to quantify and isolate Muscle satelitte celss, fibro-adipogenic progenitors and macrofages
Time frame: 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
Time frame: 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.
Time frame: 12 weeks
Vo2max test on a bike and estimated via Ventriject
Time frame: 12 weeks
Bike test with increasing intensity steps
Time frame: 12 weeks
Time frame: 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"
Time frame: 12 weeks
Accelerometers
Time frame: 12 weeks
sit-and-reach test
Time frame: 12 weeks
Lachmeter test
Time frame: 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
Time frame: 12 weeks
Time frame: 12 weeks
Determination of blood volume and haemoglobin mass by the carbon-monoxide rebreathing method
Time frame: 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
Time frame: 12 weeks
Before the intervention and during during rehabilization
Time frame: 12 weeks
Time frame: 12 weeks
Contact information is provided by the study sponsor or research team.
Mette Hansen
Other
Acronym: HER-MUSCLE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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