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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)

2026年6月9日 更新者: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:

  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.

研究概览

地位

招聘中

详细说明

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.

研究类型

观察性的

注册 (估计的)

30

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名:Mette Hansen, PhD
  • 电话号码:+4551666551
  • 邮箱:mhan@ph.au.dk

学习地点

      • Aarhus、丹麦、8000
        • 招聘中
        • Aarhus University
        • 接触:
          • Mette Hansen, PhD
          • 电话号码:+4551666551
          • 邮箱:mhan@ph.au.dk
        • 首席研究员:
          • Mette Hansen, PhD

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

取样方法

非概率样本

研究人群

Participants will primarily be recruited from a radius of 50km from Aarhus.

Participants recruited will be age matched to participants in the main trial.

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
Post menopausal women
Pre menopausal women

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Muscle mass
大体时间:1 week
Magnetic resonance imaging
1 week

次要结果测量

结果测量
措施说明
大体时间
Mitochondria Function in vivo measured as phosphocreatine recovery rate
大体时间: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).
1 weeks
Mitochondria Function in vitro measured as maximal oxygen consumption
大体时间: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.
1 weeks
Body composition
大体时间:1 weeks
DXA
1 weeks
Satelitte cells
大体时间:1 weeks
Histochemical Analysis of Muscle tisse
1 weeks
Muscle fiber cross-sectional Area
大体时间:1 weeks
Histochemical Analysis of Muscle Tissue
1 weeks
Expression of Muscle proteins
大体时间:1 weeks
Western blotting analysis
1 weeks
FACS Analysis
大体时间:1 weeks
FACS analysis to quantify and isolate Muscle satelitte celss, fibro-adipogenic progenitors and macrofages
1 weeks
Muscle Strength
大体时间: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
1 weeks
Functional tests
大体时间: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
Cardiovascular fitness
大体时间:1 week
Vo2max test on a bike and estimated via Ventriject
1 week
Maximal fat oxidation rate
大体时间:1 week
Bike test with increasing intensity steps
1 week
Resisting metabolic rate
大体时间:1 week
1 week
Questionaires
大体时间: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"
1 week
Physical Activity Level
大体时间:1 week
Accelerometers
1 week
Flexibility
大体时间:1 week
sit-and-reach test
1 week
Knee laxity
大体时间:1 week
Lachmeter test
1 week
Protein expression in adipose tissue
大体时间: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
1 week
Blood pressure
大体时间:1 week
1 week
Blood volume
大体时间:1 week
Determination of blood volume and haemoglobin mass by the carbon-monoxide rebreathing method
1 week

其他结果措施

结果测量
措施说明
大体时间
Blood analysis
大体时间: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
1 week
Dairy record registration
大体时间:1 week
A total of five days prior to the test
1 week
Height
大体时间:1 week
1 week
Body mass
大体时间:1 week
1 week

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

调查人员

  • 首席研究员:Mette Hansen, PhD、Aarhus University, Department of Public Health

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年2月1日

初级完成 (估计的)

2027年8月1日

研究完成 (估计的)

2027年8月1日

研究注册日期

首次提交

2026年2月27日

首先提交符合 QC 标准的

2026年6月9日

首次发布 (实际的)

2026年6月16日

研究记录更新

最后更新发布 (实际的)

2026年6月16日

上次提交的符合 QC 标准的更新

2026年6月9日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • E30 HER-MUSCLE cross sectional

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Do to GDPR rules, we do not plan to share

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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