The Anabolic Effects of Estrogen on Skeletal Muscles (ESTRO)

September 25, 2019 updated by: University of Aarhus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Sport Science, Department of Public Health, Aarhus University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise + Estrogen
Strength training 3 times a week for 12 weeks. Estrogen patches which provide 100 um pr. 24 hours.
Other: Exercise + Estrogen
12 weeks resistance training and estrogen patches
Active Comparator: Exercise + Placebo
Strength training 3 times a week for 12 weeks. Placebo patches.
Other: Exercise + Placebo
12 weeks resistance training and placebo patches

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle hypertrophy
Time Frame: 12 weeks
muscle cross sectional area measured by Magnetic resonance imaging (MR) -scans
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle fiber hypertrophy
Time Frame: 12 weeks
Histology analysis of muscle fiber area
12 weeks
Muscle strength
Time Frame: 12 weeks
Maximal isometric muscle strength
12 weeks
tendon size
Time Frame: 12 weeks
Tendon cross sectional area measured by MR-scan
12 weeks
Fat cell size
Time Frame: 12 weeks
Analysis of fat cell size (diameter)
12 weeks
Fat mass
Time Frame: 12 weeks
Dual-energy X-ray absorptiometry (DXA) scan of total fat mass
12 weeks
Fat free mass
Time Frame: 12 weeks
Fat free mass measured by DXA scan
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

February 15, 2018

Study Completion (Actual)

February 15, 2018

Study Registration Dates

First Submitted

December 15, 2016

First Submitted That Met QC Criteria

January 11, 2017

First Posted (Estimate)

January 13, 2017

Study Record Updates

Last Update Posted (Actual)

September 27, 2019

Last Update Submitted That Met QC Criteria

September 25, 2019

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Estrogen2016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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