The Anabolic Effects of Estrogen on Skeletal Muscles

Not Applicable

Completed

• Conditions: Estrogen Supplementation
• Interventions: Other: Exercise + Estrogen; Other: Exercise + Placebo

• Registration Number: NCT03020953
• Lead Sponsor: University of Aarhus

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-15
• Study Start: 2017-01-01
• Study First Submitted QC: 2017-01-11
• Study First Posted: 2017-01-13
• Primary Completion: 2018-02-15
• Study Completion: 2018-02-15
• Status Verified: 2018-06
• Last Update Submitted: 2019-09-25
• Last Update Posted: 2019-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 31

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise + Estrogen	Exercise + Estrogen	Strength training 3 times a week for 12 weeks. Estrogen patches which provide 100 um pr. 24 hours.
Exercise + Placebo	Exercise + Placebo	Strength training 3 times a week for 12 weeks. Placebo patches.

Primary Outcome Measures

Name	Time	Method
Muscle hypertrophy	12 weeks	muscle cross sectional area measured by Magnetic resonance imaging (MR) -scans

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sport Science, Department of Public Health, Aarhus University; 🇩🇰 Aarhus, Denmark