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OpenTrials
Completed

NCT Number: NCT03020953

The Anabolic Effects of Estrogen on Skeletal Muscles

Purpose: to study the effect of estrogen replacement on muscle hypertrophy in response to 12 weeks resistance training in postmenopausal women Hypothesis: Transdermal administration of 17-β estradiol enhance the anabolic effect of resistance training on muscle mass, strength in postmenopausal women Primary outcome: Muscle hypertrophy (muscle CSA, muscle fiber type specific CSA) Secondary outcome: Messenger RiboNucleic Acid (mRNA)(real-time PCR), protein (western blotting), satellite cell proliferation and activation, Strength, functional test, muscle protein synthese.

Design: Two groups of healthy postmenopausal women (½-5 years after menopause) who have not performed regular resistance exercise (<1 times per week) the last two years. Randomized, controlled intervention study +/- transdermal administration of estrogen (17-β estradiol). Both groups perform 12 weeks of supervised progressive resistance training (3/week) aiming to induce muscle hypertrophy in the legs.

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Key information

Conditions

Estrogen Supplementation

Age range

40 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sport Science, Department of Public Health, Aarhus University

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Postmenopausal women, more than 6 months, but less than 5 years since last menstruation.

Exclusion criteria

  • Less than 2 hours exercise with moderate to high intensity per week the last year, no regular resistance exercise the last 2 years (less than 5 exercise bouts during the last year)
  • No previous or present lower limb injuries which may hinder participation in strength training
  • No use of medicine which may influence the adaptation to strength training such as regular use of nonsteroidal anti-inflammatory drugs and use of statins, no muscle
  • Joint or metabolic diseases or other chronic diseases that would affect the results of the investigation, high blood pressure (>140/90), smoking

Treatment and study plan

Exercise + Estrogen

Other

12 weeks resistance training and estrogen patches

Exercise + Placebo

Other

12 weeks resistance training and placebo patches

Primary outcomes

  1. Muscle hypertrophy

    Time frame: 12 weeks

    muscle cross sectional area measured by Magnetic resonance imaging (MR) -scans

Secondary outcomes

  1. Muscle fiber hypertrophy

    Time frame: 12 weeks

    Histology analysis of muscle fiber area

  2. Muscle strength

    Time frame: 12 weeks

    Maximal isometric muscle strength

  3. tendon size

    Time frame: 12 weeks

    Tendon cross sectional area measured by MR-scan

  4. Fat cell size

    Time frame: 12 weeks

    Analysis of fat cell size (diameter)

  5. Fat mass

    Time frame: 12 weeks

    Dual-energy X-ray absorptiometry (DXA) scan of total fat mass

  6. Fat free mass

    Time frame: 12 weeks

    Fat free mass measured by DXA scan

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Acronym: ESTRO

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 13, 2017
Registry last updated
Sep 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.