The Influence of Oral Contraceptive Use on Muscle Recovery

Study Overview
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Brief Summary
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There is still no one who has studied how oral contraceptive use affects recovery in trained women after repeated high-intensity workouts. Consequently, a well-controlled study is needed. The project is designed as a controlled cohort study, where 20 oral contraceptive users will be compared with 20 non-users. After initial preliminary examination and habituation to the test procedures, the subjects will start the intervention in week 2 of their menstrual cycle / active contraceptive pill cycle. Before and 3h, 24h and 48h after 3 intense strength training sessions performed 2 days in a row, blood samples will be taken, muscle soreness measured and performance tests performed. The day before the first training session and over the 4 trial days, the subjects will receive a standardized diet.

Official Title
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Influence of Oral Contraceptive Use on Recovery in Trained Women

Conditions
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Recovery, Oral Contraceptive Use

Intervention / Treatment
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* Procedure: Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI 18.5-30 Regular training minimum. 4 times a week (1≤ times strength training, 1≤ times endurance training / interval training or interval-based sports. If the interest in participation is greater than necessary, we will prioritize people who perform strength training at least twice a week) Exclusion Criteria: Irregular menstruation over the last 6 months (shorter than 24 days or longer than 35 days cycle) Used birth control pills for less than 6 months Non-birth control pill users must not have used birth control pills, IUDs, birth control pills, or mini- pills for a maximum of 1 month during the last 6 months and not within the last 3 months up to the trial. . Injuries / pain in the lower body, which prevents participation in intense strength training Medication consumption that may affect protein metabolism and inflammatory parameters. Diabetes Smoking Unstable weight / major weight loss (weight fluctuations of more than 5 kg in the last six months) Eating disorder Pregnancy Cannot read or understand Danish

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: We will compare the recovery in a group of oral contraceptive users to a group of women not using oral contraceptives
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral contraceptive users<br> | Procedure: Training<br>* Both groups will perform a standardized training protocol<br>|
| Active Comparator: Non-oral contraceptive users<br> | Procedure: Training<br>* Both groups will perform a standardized training protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in maximal knee extensor strength and Rate of force development | Measured in a Humac Norm dynamometer | Before, 3 hours , 24 hours and 48 hours after training | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Jumping performance | Jump height | Before, 3 hours , 24 hours and 48 hours after training. | 
| Changes in Jumping performance | Power | Before, 3 hours , 24 hours and 48 hours after training. | 
| Changes in Jumping performance | modified reactive strength index | Before, 3 hours , 24 hours and 48 hours after training. | 
| Changes in Jumping performance | leg stiffness | Before, 3 hours , 24 hours and 48 hours after training. | 
| Changes in Wingate performance | Peak power and average power | Before, 3 hours , 24 hours and 48 hours after training. | 
| Changes in Yoyo-intermittent recovery 1 performance | total length covered in the yo-yo test | Before, and 48 hours after training. | 
| Changes in Leg press performance | Total reps performed at 80% of 1RM | Before, 3 hours , 24 hours and 48 hours after training. | 
| Changes training volume | total volume performed during training (i.e set x reps x working weight) | Before, 3 hours , 24 hours and 48 hours after training. | 
| Differences in knee laxity | Measured with a Lachmeter | Baseline | 
| Changes in muscle soreness (VAS-score) | Subjects will raise and sit on a chair and immediately after answer a VAS-score (100mm line, from worst pain ever, to no pain at all.) | Before, 3 hours , 24 hours and 48 hours after training | 
| Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage | estradiol | Before, 3 hours , 24 hours and 48 hours after training | 
| Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage | testosterone | Before, 3 hours , 24 hours and 48 hours after training | 
| Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage | sex hormone-binding globulin | Before, 3 hours , 24 hours and 48 hours after training | 
| Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage | progesterone | Before, 3 hours , 24 hours and 48 hours after training | 
| Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage | follicle-stimulating hormone | Before, 3 hours , 24 hours and 48 hours after training | 
| Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage | luteinizing hormone | Before, 3 hours , 24 hours and 48 hours after training | 
| Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage | Creatine kinase | Before, 3 hours , 24 hours and 48 hours after training | 
| Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage | Lactate dehydrogenase | Before, 3 hours , 24 hours and 48 hours after training | 
| Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage | Myoglobin | Before, 3 hours , 24 hours and 48 hours after training | 
| Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage | Cortisol | Before, 3 hours , 24 hours and 48 hours after training | 
| Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage | C-reactive protein | Before, 3 hours , 24 hours and 48 hours after training | 
| Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage | tumor necrosis factor | Before, 3 hours , 24 hours and 48 hours after training | 
| Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage | IL-6 | Before, 3 hours , 24 hours and 48 hours after training |