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Effects of Estrogen on Muscle Gain During 12-weeks of Exercise in Post-menopausal Women (HER-MUSCLE)

23. maj 2026 opdateret af: Mette Hansen

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret 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 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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Mette Hansen, PhD
  • Telefonnummer: +4551666551
  • E-mail: mhan@ph.au.dk

Studiesteder

  • Danmark
    • Jutland
      • Aarhus, Jutland, Danmark, 8000
        • Rekruttering
        • Aarhus University
        • Kontakt:
          • Mette Hansen, PhD
          • Telefonnummer: +4551666551
          • E-mail: mhan@ph.au.dk

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • 1-10 years since last menstrual bleeding
  • Age > 40 years old
  • BMI 20-30

Exclusion Criteria:

  • Follicular stimulating hormone < 30 mmol/L
  • Systematic strength training during the last year (> 1 strength training session 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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Estrogen
Transdermal Estrogen Administration
Medicin: Estrogel
The other group receive placebo treatment
Adfærdsmæssigt: Physical exercise
Both groups will go through 12 weeks of supervised physical exercise, consisting of both strength training and cardiovascular training
Placebo komparator: Placebo
Transdermal placebo administration
Adfærdsmæssigt: Physical exercise
Both groups will go through 12 weeks of supervised physical exercise, consisting of both strength training and cardiovascular training

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Muscle mass
Tidsramme: 12 weeks
Magnetic resonance imaging of one leg before and after intervention
12 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Blodtryk
Tidsramme: 12 uger
12 uger
Mitochondria Function in vivo measured as phosphocreatine recovery rate
Tidsramme: 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).
12 weeks
Mitochondria Function in vitro measured as maximal oxygen consumption
Tidsramme: 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.
12 weeks
Body composition
Tidsramme: 12 weeks
DXA
12 weeks
Satelitte cells
Tidsramme: 12 weeks
Histochemical Analysis of Muscle tisse
12 weeks
Muscle fiber cross-sectional Area
Tidsramme: 12 weeks
Histochemical Analysis of Muscle Tissue
12 weeks
Expression of Muscle proteins
Tidsramme: 12 weeks
Western blotting analysis
12 weeks
FACS Analysis
Tidsramme: 12 weeks
FACS analysis to quantify and isolate Muscle satelitte celss, fibro-adipogenic progenitors and macrofages
12 weeks
Muscle Strength
Tidsramme: 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
12 weeks
Functional test
Tidsramme: 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.
12 weeks
Cardiovascular fitness
Tidsramme: 12 weeks
Vo2max test on a bike and estimated via Ventriject
12 weeks
Maximal fat oxidation rate
Tidsramme: 12 weeks
Bike test with increasing intensity steps
12 weeks
Resisting metabolic rate
Tidsramme: 12 weeks
12 weeks
Questionaires
Tidsramme: 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"
12 weeks
Physical Activity Level
Tidsramme: 12 weeks
Accelerometers
12 weeks
Flexibility
Tidsramme: 12 weeks
sit-and-reach test
12 weeks
Knee laxity
Tidsramme: 12 weeks
Lachmeter test
12 weeks
Protein expression in adipose tissue
Tidsramme: 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
12 weeks
Blood volume
Tidsramme: 12 weeks
Determination of blood volume and haemoglobin mass by the carbon-monoxide rebreathing method
12 weeks

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Højde
Tidsramme: 12 uger
12 uger
Blood analysis
Tidsramme: 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
12 weeks
Dairy record registration
Tidsramme: 12 weeks
Before the intervention and during during rehabilization
12 weeks
Body mass
Tidsramme: 12 weeks
12 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Mette Hansen

Samarbejdspartnere

Aarhus University Hospital
University of Copenhagen
Aalborg University

Efterforskere

  • Ledende efterforsker: Mette Hansen, PhD, Aarhus University, Department of Public Health

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. februar 2026

Primær færdiggørelse (Anslået)

1. august 2027

Studieafslutning (Anslået)

1. august 2027

Datoer for studieregistrering

Først indsendt

27. februar 2026

Først indsendt, der opfyldte QC-kriterier

23. maj 2026

Først opslået (Faktiske)

1. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • E30 HER-MUSCLE Intervention

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Do to GDPR rules, we do not plan to share

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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