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 uppdaterad 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.
Studieöversikt
Status
Rekrytering
Betingelser
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Beräknad)
30
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Mette Hansen, PhD
- Telefonnummer: +4551666551
- E-post: mhan@ph.au.dk
Studieorter
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-
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Aarhus, Danmark, 8000
- Rekrytering
- Aarhus University
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Kontakt:
- Mette Hansen, PhD
- Telefonnummer: +4551666551
- E-post: mhan@ph.au.dk
-
Huvudutredare:
- Mette Hansen, PhD
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Participants will primarily be recruited from a radius of 50km from Aarhus.
Participants recruited will be age matched to participants in the main trial.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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Post menopausal women
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Pre menopausal women
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Muscle mass
Tidsram: 1 week
|
Magnetic resonance imaging
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1 week
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Mitochondria Function in vivo measured as phosphocreatine recovery rate
Tidsram: 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
Tidsram: 1 weeks
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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
Tidsram: 1 weeks
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DXA
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1 weeks
|
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Satelitte cells
Tidsram: 1 weeks
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Histochemical Analysis of Muscle tisse
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1 weeks
|
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Muscle fiber cross-sectional Area
Tidsram: 1 weeks
|
Histochemical Analysis of Muscle Tissue
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1 weeks
|
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Expression of Muscle proteins
Tidsram: 1 weeks
|
Western blotting analysis
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1 weeks
|
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FACS Analysis
Tidsram: 1 weeks
|
FACS analysis to quantify and isolate Muscle satelitte celss, fibro-adipogenic progenitors and macrofages
|
1 weeks
|
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Muscle Strength
Tidsram: 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
Tidsram: 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.
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1 weeks
|
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Cardiovascular fitness
Tidsram: 1 week
|
Vo2max test on a bike and estimated via Ventriject
|
1 week
|
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Maximal fat oxidation rate
Tidsram: 1 week
|
Bike test with increasing intensity steps
|
1 week
|
|
Resisting metabolic rate
Tidsram: 1 week
|
1 week
|
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Questionaires
Tidsram: 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
Tidsram: 1 week
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Accelerometers
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1 week
|
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Flexibility
Tidsram: 1 week
|
sit-and-reach test
|
1 week
|
|
Knee laxity
Tidsram: 1 week
|
Lachmeter test
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1 week
|
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Protein expression in adipose tissue
Tidsram: 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
Tidsram: 1 week
|
1 week
|
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Blood volume
Tidsram: 1 week
|
Determination of blood volume and haemoglobin mass by the carbon-monoxide rebreathing method
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1 week
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Blood analysis
Tidsram: 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
Tidsram: 1 week
|
A total of five days prior to the test
|
1 week
|
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Height
Tidsram: 1 week
|
1 week
|
|
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Body mass
Tidsram: 1 week
|
1 week
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Mette Hansen, PhD, Aarhus University, Department of Public Health
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 februari 2026
Primärt slutförande (Beräknad)
1 augusti 2027
Avslutad studie (Beräknad)
1 augusti 2027
Studieregistreringsdatum
Först inskickad
27 februari 2026
Först inskickad som uppfyllde QC-kriterierna
9 juni 2026
Första postat (Faktisk)
16 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
16 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
9 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- E30 HER-MUSCLE cross sectional
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
Do to GDPR rules, we do not plan to share
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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