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.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age47+
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 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Regular menstrual bleeding (21-35 days cycle).

At least 9 menstrual cycles the last year

Age >47 years old

BMI 20-30

Disqualifiers

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

Trial 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.

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

30 Participants
are grouped into 2 trial groups
Group A: Post menopausal women
Group B: Pre menopausal women

Trial outcomes

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

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

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