Oral Contraceptive and Strength Training
Overview
Cross sectional study investigating the effect of strength training in users and non-users of oral contraceptives (OC) (2nd generation OC)
Full Title of Study: “E5 – Oral Contraceptive and Strength Training (2nd Generation)”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Basic Science
- Masking: None (Open Label)
- Study Primary Completion Date: January 1, 2019
Interventions
- Other: no oral contraceptive and training
- 10 weeks of training in a group of oral contraceptive users
- Other: oral contraceptive and training
- 10 weeks of training in a group of users of oral contraceptives
Arms, Groups and Cohorts
- Experimental: oral contraceptive and training
- Users of oral contraceptive training for 10 weeks
- Placebo Comparator: no oral contraceptive and training
- Non-users of oral contraceptive training for 10 weeks
Clinical Trial Outcome Measures
Primary Measures
- Muscle mass
- Time Frame: Baseline + after 10 weeks of resistance training.
- Change in muscle mass determined by MRI scan of thigh muscle
Secondary Measures
- Muscle fiber size
- Time Frame: Baseline + after 10 weeks of resistance training.
- Change in muscle fiber cross sectional area measured by histology.
- Muscle strength
- Time Frame: Baseline + after 10 weeks of resistance training.
- Change in isometric strength
- Blood values
- Time Frame: Baseline + after 10 weeks of resistance training.
- Change in sex hormone profile measured by blood sample analysis
- Functionality
- Time Frame: Baseline + after 10 weeks of resistance training.
- Change in jump performance by RSI (Reactive strength index) measures
- Fat free mass (FFM)
- Time Frame: Baseline + after 10 weeks of resistance training.
- Change in FFM measured by dual energy x-ray absorptiometry (DXA) scan of whole body composition
Participating in This Clinical Trial
Inclusion Criteria
- 18.5 – 30 years – BMI < 30 Exclusion Criteria:
- Medicine influencing protein turnover – Surgery on the knee – Arthritis – Diabetes – Smoking – irregular menstruation (<24 days or >35 days cycles) – Non-users: not have used contraceptives for the last 3 months. – Unstable weight (+/- 5 kg within the last 6 months) – Regular training/exercise more than 2 hours/week for the last 6 months. Maximum 70 km of cycling transport/week. – Strength training >1time/month for the last 6 months. – Pregnancy – Diet og eating disorder – Can not read or understand danish
Gender Eligibility: Female
Use of oral contraceptives compared to same sex controls.
Minimum Age: 18 Years
Maximum Age: 30 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- University of Aarhus
- Provider of Information About this Clinical Study
- Principal Investigator: Mette Hansen, Associate Professor – University of Aarhus
- Overall Official(s)
- Mette Hansen, PhD, Principal Investigator, University of Aarhus
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