Muscle Mass and StrengthHER-MUSCLEXNCT07649356
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.
An observational study of Muscle Mass and Strength and Menopause, run by Mette Hansen at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 47 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Mass and Strength, Menopause
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2026to 1 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 47 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will primarily be recruited from a radius of 50km from Aarhus. Participants recruited will be age matched to participants in the main trial.
Who may be able to join
- Regular menstrual bleeding (21-35 days cycle).
- At least 9 menstrual cycles the last year
- Age >47 years old
- BMI 20-30
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University
Aarhus, 8000
Mette Hansen, PhD, +4551666551, mhan@ph.au.dk
Mette Hansen, PhD
About this study
Official title: 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Muscle Mass and Strength, Menopause
- Keywords
- Muslce Mass, Muscle Strength, Menopause, Estrogen, Mitochondria function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Post menopausal women | Not described | |
| Pre menopausal women | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle mass
Magnetic resonance imaging
Measured: 1 week
Secondary outcomes (19)
Mitochondria Function in vivo measured as phosphocreatine recovery rate
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).
Measured: 1 weeks
Mitochondria Function in vitro measured as maximal oxygen consumption
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.
Measured: 1 weeks
Body composition
DXA
Measured: 1 weeks
Satelitte cells
Histochemical Analysis of Muscle tisse
Measured: 1 weeks
Muscle fiber cross-sectional Area
Histochemical Analysis of Muscle Tissue
Measured: 1 weeks
Expression of Muscle proteins
Western blotting analysis
Measured: 1 weeks
FACS Analysis
FACS analysis to quantify and isolate Muscle satelitte celss, fibro-adipogenic progenitors and macrofages
Measured: 1 weeks
Muscle Strength
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
Measured: 1 weeks
Functional tests
Includes counter-movement jump on a speed force-platform (Swift performance, Australia). To measure dexterity, the nine-hole peg test will be applied.
Measured: 1 weeks
Cardiovascular fitness
Vo2max test on a bike and estimated via Ventriject
Measured: 1 week
Maximal fat oxidation rate
Bike test with increasing intensity steps
Measured: 1 week
Resisting metabolic rate
Measured: 1 week
Questionaires
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"
Measured: 1 week
Physical Activity Level
Accelerometers
Measured: 1 week
Flexibility
sit-and-reach test
Measured: 1 week
Knee laxity
Lachmeter test
Measured: 1 week
Protein expression in adipose tissue
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
Measured: 1 week
Blood pressure
Measured: 1 week
Blood volume
Determination of blood volume and haemoglobin mass by the carbon-monoxide rebreathing method
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start1 Feb 2026
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Mass and StrengthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mette Hansen
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University, University of Copenhagen, Aarhus University Hospital
- Responsible party
- Sponsor-investigator, Mette Hansen, University of Aarhus
- Investigators
- Mette Hansen, PhD, Principal investigator, Aarhus University, Department of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07649356
- Sponsor's protocol ID
- E30 HER-MUSCLE cross sectional
- Acronym
- HER-MUSCLEX
- Status last verified
- Jun 2026
- First submitted
- 27 Feb 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Do to GDPR rules, we do not plan to share
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Estrogen on Muscle Gain During 12-weeks of Exercise in Post-menopausal Women
- ClinicalTrials.gov ID
- NCT07649356
- Acronym / sponsor ID
- HER-MUSCLEX / E30 HER-MUSCLE cross sectional
- Conditions
- Muscle Mass and Strength, Menopause
- Keywords
- Muslce Mass, Muscle Strength, Menopause, Estrogen, Mitochondria function
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mette HansenUniversity, hospital or other
- Collaborators
- Aalborg University, University of Copenhagen, Aarhus University Hospital
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post menopausal women | – | – |
| Pre menopausal women | – | – |
Who may qualify
- Ages
- 47 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will primarily be recruited from a radius of 50km from Aarhus. Participants recruited will be age matched to participants in the main trial.
Key inclusion criteria (4 listed)
- Regular menstrual bleeding (21-35 days cycle).
- At least 9 menstrual cycles the last year
- Age >47 years old
- BMI 20-30
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Muscle mass
Time frame: 1 week
Magnetic resonance imaging
19 secondary outcomes
Mitochondria Function in vivo measured as phosphocreatine recovery rate
Time frame: 1 weeks
Mitochondria Function in vitro measured as maximal oxygen consumption
Time frame: 1 weeks
Body composition
Time frame: 1 weeks
Satelitte cells
Time frame: 1 weeks
Muscle fiber cross-sectional Area
Time frame: 1 weeks
Expression of Muscle proteins
Time frame: 1 weeks
FACS Analysis
Time frame: 1 weeks
Muscle Strength
Time frame: 1 weeks
Functional tests
Time frame: 1 weeks
Cardiovascular fitness
Time frame: 1 week
Maximal fat oxidation rate
Time frame: 1 week
Resisting metabolic rate
Time frame: 1 week
Questionaires
Time frame: 1 week
Physical Activity Level
Time frame: 1 week
Flexibility
Time frame: 1 week
Knee laxity
Time frame: 1 week
Protein expression in adipose tissue
Time frame: 1 week
Blood pressure
Time frame: 1 week
Blood volume
Time frame: 1 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Project homepageLink provided by the sponsor.
- Individual participant dataSharing planned: No. Do to GDPR rules, we do not plan to share
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mette Hansen, PhD principal investigator
Aarhus University, Department of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Muscle Mass and Strength and Menopause, run by Mette Hansen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mette Hansen, PhD (+4551666551, mhan@ph.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle mass (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.