The Anabolic Effects of Estrogen on Skeletal Muscles

Estrogen Supplementation Clinical Trial

— ESTRO  

Official title:

The Anabolic Effects of Estrogen on Skeletal Muscles

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03020953
• Other study ID #: Estrogen2016
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: February 15, 2018

Study information

• Verified date: June 2018
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: February 15, 2018
• Est. primary completion date: February 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Estrogen Supplementation

Intervention

Other:
• Exercise + Estrogen
12 weeks resistance training and estrogen patches
• Exercise + Placebo
12 weeks resistance training and placebo patches

Locations

Country	Name	City	State
Denmark	Sport Science, Department of Public Health, Aarhus University	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle hypertrophy	muscle cross sectional area measured by Magnetic resonance imaging (MR) -scans	12 weeks
Secondary	Muscle fiber hypertrophy	Histology analysis of muscle fiber area	12 weeks
Secondary	Muscle strength	Maximal isometric muscle strength	12 weeks
Secondary	tendon size	Tendon cross sectional area measured by MR-scan	12 weeks
Secondary	Fat cell size	Analysis of fat cell size (diameter)	12 weeks
Secondary	Fat mass	Dual-energy X-ray absorptiometry (DXA) scan of total fat mass	12 weeks
Secondary	Fat free mass	Fat free mass measured by DXA scan	12 weeks