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. juni 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Forhold
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Antatt)
30
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Mette Hansen, PhD
- Telefonnummer: +4551666551
- E-post: mhan@ph.au.dk
Studiesteder
-
-
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Aarhus, Danmark, 8000
- Rekruttering
- Aarhus University
-
Ta kontakt med:
- Mette Hansen, PhD
- Telefonnummer: +4551666551
- E-post: mhan@ph.au.dk
-
Hovedetterforsker:
- Mette Hansen, PhD
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Participants will primarily be recruited from a radius of 50km from Aarhus.
Participants recruited will be age matched to participants in the main trial.
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Post menopausal women
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Pre menopausal women
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Muscle mass
Tidsramme: 1 week
|
Magnetic resonance imaging
|
1 week
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Mitochondria Function in vivo measured as phosphocreatine recovery rate
Tidsramme: 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
Tidsramme: 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
Tidsramme: 1 weeks
|
DXA
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1 weeks
|
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Satelitte cells
Tidsramme: 1 weeks
|
Histochemical Analysis of Muscle tisse
|
1 weeks
|
|
Muscle fiber cross-sectional Area
Tidsramme: 1 weeks
|
Histochemical Analysis of Muscle Tissue
|
1 weeks
|
|
Expression of Muscle proteins
Tidsramme: 1 weeks
|
Western blotting analysis
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1 weeks
|
|
FACS Analysis
Tidsramme: 1 weeks
|
FACS analysis to quantify and isolate Muscle satelitte celss, fibro-adipogenic progenitors and macrofages
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1 weeks
|
|
Muscle Strength
Tidsramme: 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
Tidsramme: 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.
|
1 weeks
|
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Cardiovascular fitness
Tidsramme: 1 week
|
Vo2max test on a bike and estimated via Ventriject
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1 week
|
|
Maximal fat oxidation rate
Tidsramme: 1 week
|
Bike test with increasing intensity steps
|
1 week
|
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Resisting metabolic rate
Tidsramme: 1 week
|
1 week
|
|
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Questionaires
Tidsramme: 1 week
|
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
Tidsramme: 1 week
|
Accelerometers
|
1 week
|
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Flexibility
Tidsramme: 1 week
|
sit-and-reach test
|
1 week
|
|
Knee laxity
Tidsramme: 1 week
|
Lachmeter test
|
1 week
|
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Protein expression in adipose tissue
Tidsramme: 1 week
|
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
Tidsramme: 1 week
|
1 week
|
|
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Blood volume
Tidsramme: 1 week
|
Determination of blood volume and haemoglobin mass by the carbon-monoxide rebreathing method
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1 week
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Blood analysis
Tidsramme: 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
Tidsramme: 1 week
|
A total of five days prior to the test
|
1 week
|
|
Height
Tidsramme: 1 week
|
1 week
|
|
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Body mass
Tidsramme: 1 week
|
1 week
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Mette Hansen, PhD, Aarhus University, Department of Public Health
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. februar 2026
Primær fullføring (Antatt)
1. august 2027
Studiet fullført (Antatt)
1. august 2027
Datoer for studieregistrering
Først innsendt
27. februar 2026
Først innsendt som oppfylte QC-kriteriene
9. juni 2026
Først lagt ut (Faktiske)
16. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
16. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- E30 HER-MUSCLE cross sectional
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
Do to GDPR rules, we do not plan to share
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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