CClinicalTrials.gg
RecruitingNCT07649356HER-MUSCLEXUpdated Jun 16, 2026

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 in Muscle Mass and Strength and Menopause, sponsored by Mette Hansen. Recruiting at 1 site in Denmark. Open to female participants aged 47 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-16.

Sponsored by Mette Hansen · Observational

From the registry’s dates

  • Started Feb 2026; still recruiting 8 months later.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
30
Ages
47 Years and older
Sex
Female
01

Study 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.

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:

  1. 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.
  2. 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:

  1. 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.
  2. 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.

02

Conditions studied

  • Muscle Mass and Strength
  • Menopause

Keywords

  • Muslce Mass
  • Muscle Strength
  • Menopause
  • Estrogen
  • Mitochondria function
03

In context

Lead sponsor

Mette Hansen is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
47 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

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

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
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • Post menopausal women
  • Pre menopausal women
06

What researchers measure

Primary outcomes

  1. Muscle mass

    Magnetic resonance imaging

    Time frame: 1 week

Secondary outcomes

  1. 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).

    Time frame: 1 weeks

  2. 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.

    Time frame: 1 weeks

  3. Body composition

    DXA

    Time frame: 1 weeks

  4. Satelitte cells

    Histochemical Analysis of Muscle tisse

    Time frame: 1 weeks

  5. Muscle fiber cross-sectional Area

    Histochemical Analysis of Muscle Tissue

    Time frame: 1 weeks

  6. Expression of Muscle proteins

    Western blotting analysis

    Time frame: 1 weeks

  7. FACS Analysis

    FACS analysis to quantify and isolate Muscle satelitte celss, fibro-adipogenic progenitors and macrofages

    Time frame: 1 weeks

  8. 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

    Time frame: 1 weeks

  9. 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.

    Time frame: 1 weeks

  10. Cardiovascular fitness

    Vo2max test on a bike and estimated via Ventriject

    Time frame: 1 week

  11. Maximal fat oxidation rate

    Bike test with increasing intensity steps

    Time frame: 1 week

  12. Resisting metabolic rate

    Time frame: 1 week

  13. 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"

    Time frame: 1 week

  14. Physical Activity Level

    Accelerometers

    Time frame: 1 week

  15. Flexibility

    sit-and-reach test

    Time frame: 1 week

  16. Knee laxity

    Lachmeter test

    Time frame: 1 week

  17. 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

    Time frame: 1 week

  18. Blood pressure

    Time frame: 1 week

  19. Blood volume

    Determination of blood volume and haemoglobin mass by the carbon-monoxide rebreathing method

    Time frame: 1 week

Other outcomes

  1. Blood analysis

    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

    Time frame: 1 week

  2. Dairy record registration

    A total of five days prior to the test

    Time frame: 1 week

  3. Height

    Time frame: 1 week

  4. Body mass

    Time frame: 1 week

07

Study locations

1 of 1 sites recruiting
  • Aarhus University
    Aarhus, 8000, Denmark
    • Mette Hansen, PhD · Contact · mhan@ph.au.dk · +4551666551
    • Mette Hansen, PhD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — Do to GDPR rules, we do not plan to share

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07649356
Lead sponsor
Mette Hansen
Collaborators
Aalborg University, University of Copenhagen, Aarhus University Hospital
Responsible party
Mette Hansen (Professor, University of Aarhus) — Sponsor-investigator
First posted
Jun 16, 2026
Start date
Feb 1, 2026
Primary completion
Aug 1, 2027 (estimated)
Completion
Aug 1, 2027 (estimated)
Last update
Jun 16, 2026

Study contacts

Mette Hansen, PhD
Contact
mhan@ph.au.dk
+4551666551
Mette Hansen, PhD
principal investigator · Aarhus University, Department of Public Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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