Clinical trial NCT04564300: The Influence of Oral Contraceptive Use on Muscle Recovery
Official title: Influence of Oral Contraceptive Use on Recovery in Trained Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recovery
Oral Contraceptive Use
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2020-09-25
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We will compare the recovery in a group of oral contraceptive users to a group of women not using oral contraceptives
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in maximal knee extensor strength and Rate of force development
timeFrame: Before, 3 hours , 24 hours and 48 hours after training
Secondary outcomes:
measure: Changes in Jumping performance
timeFrame: Before, 3 hours , 24 hours and 48 hours after training.
measure: Changes in Jumping performance
timeFrame: Before, 3 hours , 24 hours and 48 hours after training.
measure: Changes in Jumping performance
timeFrame: Before, 3 hours , 24 hours and 48 hours after training.
measure: Changes in Jumping performance
timeFrame: Before, 3 hours , 24 hours and 48 hours after training.
measure: Changes in Wingate performance
timeFrame: Before, 3 hours , 24 hours and 48 hours after training.
measure: Changes in Yoyo-intermittent recovery 1 performance
timeFrame: Before, and 48 hours after training.
measure: Changes in Leg press performance
timeFrame: Before, 3 hours , 24 hours and 48 hours after training.
measure: Changes training volume
timeFrame: Before, 3 hours , 24 hours and 48 hours after training.
measure: Differences in knee laxity
timeFrame: Baseline
measure: Changes in muscle soreness (VAS-score)
timeFrame: Before, 3 hours , 24 hours and 48 hours after training
measure: Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage
timeFrame: Before, 3 hours , 24 hours and 48 hours after training
measure: Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage
timeFrame: Before, 3 hours , 24 hours and 48 hours after training
measure: Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage
timeFrame: Before, 3 hours , 24 hours and 48 hours after training
measure: Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage
timeFrame: Before, 3 hours , 24 hours and 48 hours after training
measure: Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage
timeFrame: Before, 3 hours , 24 hours and 48 hours after training
measure: Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage
timeFrame: Before, 3 hours , 24 hours and 48 hours after training
measure: Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage
timeFrame: Before, 3 hours , 24 hours and 48 hours after training
measure: Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage
timeFrame: Before, 3 hours , 24 hours and 48 hours after training
measure: Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage
timeFrame: Before, 3 hours , 24 hours and 48 hours after training
measure: Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage
timeFrame: Before, 3 hours , 24 hours and 48 hours after training
measure: Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage
timeFrame: Before, 3 hours , 24 hours and 48 hours after training
measure: Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage
timeFrame: Before, 3 hours , 24 hours and 48 hours after training
measure: Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage
timeFrame: Before, 3 hours , 24 hours and 48 hours after training
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University, Department for Public Health, Section for Sport Science
Study officials:
References: