Effects of Estrogen on Muscle Gain During 12-weeks of Exercise in Post-menopausal Women

ConditionsMenopause Related Conditions Exercise Training

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age40+

SponsorMette Hansen

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

1-10 years since last menstrual bleeding

Age > 40 years old

BMI 20-30

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Estrogel
Drug
The other group receive placebo treatment
Physical exercise
Behavioral
Both groups will go through 12 weeks of supervised physical exercise, consisting of both strength training and cardiovascular training

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: EstrogenExperimental treatment 2 interventions

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Muscle mass

Magnetic resonance imaging of one leg before and after intervention

Time frame

12 weeks

Secondary outcomes

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

12 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.

Time frame

12 weeks

Body composition

DXA

Time frame

12 weeks

Satelitte cells

Histochemical Analysis of Muscle tisse

Time frame

12 weeks

Other outcomes

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-albumin Alkalisk fosfatase (ALP) 6-keto-PGF1a Endothelin-1 s-VCAM-1 s-ICAM-1 Glucose Hæmoglobin Hæmatokrit

Time frame

12 weeks

Dairy record registration

Before the intervention and during during rehabilization

Time frame

12 weeks

Height

Time frame

12 weeks

Body mass

Time frame

12 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mette Hansen

Lead sponsor

University of Aarhus

Sponsor institution

Aalborg University

Collaborator

University of Copenhagen

Collaborator

Aarhus University Hospital

Collaborator

Source ClinicalTrials.gov

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