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临床试验/NCT07617454
NCT07617454招募中不适用

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

Mette Hansen1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年2月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
Muscle mass

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

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

排除标准

  • •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
  • •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

研究组 & 干预措施

Estrogen

Experimental

Transdermal Estrogen Administration

干预措施: Physical exercise (Behavioral)

Placebo

Placebo Comparator

Transdermal placebo administration

干预措施: Physical exercise (Behavioral)

Estrogen

Experimental

Transdermal Estrogen Administration

干预措施: Estrogel (Drug)

结局指标

主要结局

Muscle mass

时间窗: 12 weeks

Magnetic resonance imaging of one leg before and after intervention

次要结局

  • Mitochondria Function in vivo measured as phosphocreatine recovery rate(12 weeks)
  • Mitochondria Function in vitro measured as maximal oxygen consumption(12 weeks)
  • Body composition(12 weeks)
  • Satelitte cells(12 weeks)
  • Muscle fiber cross-sectional Area(12 weeks)
  • Expression of Muscle proteins(12 weeks)
  • FACS Analysis(12 weeks)
  • Muscle Strength(12 weeks)
  • Functional test(12 weeks)
  • Cardiovascular fitness(12 weeks)
  • Maximal fat oxidation rate(12 weeks)
  • Resisting metabolic rate(12 weeks)
  • Questionaires(12 weeks)
  • Physical Activity Level(12 weeks)
  • Flexibility(12 weeks)
  • Knee laxity(12 weeks)
  • Protein expression in adipose tissue(12 weeks)
  • Blood pressure(12 weeks)
  • Blood volume(12 weeks)

研究者

发起方
Mette Hansen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mette Hansen

Professor

University of Aarhus

研究点 (1)

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