The Influence of Oral Contraceptive Use on Muscle Recovery

Recovery Clinical Trial

— OC-R  

Official title:

Influence of Oral Contraceptive Use on Recovery in Trained Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04564300
• Other study ID #: OC-R
• Status: Completed
• Phase: N/A
• Start date: October 19, 2020
• Est. completion date: September 27, 2023

Study information

• Verified date: May 2024
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 27, 2023
• Est. primary completion date: September 27, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Oral Contraceptive Use
• Recovery

Intervention

Procedure:
• Training
Both groups will perform a standardized training protocol

Locations

Country	Name	City	State
Denmark	Aarhus University, Department for Public Health, Section for Sport Science	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	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	Changes in Jumping performance	Jump height	Before, 3 hours , 24 hours and 48 hours after training.
Secondary	Changes in Jumping performance	Power	Before, 3 hours , 24 hours and 48 hours after training.
Secondary	Changes in Jumping performance	modified reactive strength index	Before, 3 hours , 24 hours and 48 hours after training.
Secondary	Changes in Jumping performance	leg stiffness	Before, 3 hours , 24 hours and 48 hours after training.
Secondary	Changes in Wingate performance	Peak power and average power	Before, 3 hours , 24 hours and 48 hours after training.
Secondary	Changes in Yoyo-intermittent recovery 1 performance	total length covered in the yo-yo test	Before, and 48 hours after training.
Secondary	Changes in Leg press performance	Total reps performed at 80% of 1RM	Before, 3 hours , 24 hours and 48 hours after training.
Secondary	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.
Secondary	Differences in knee laxity	Measured with a Lachmeter	Baseline
Secondary	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
Secondary	Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage	estradiol	Before, 3 hours , 24 hours and 48 hours after training
Secondary	Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage	testosterone	Before, 3 hours , 24 hours and 48 hours after training
Secondary	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
Secondary	Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage	progesterone	Before, 3 hours , 24 hours and 48 hours after training
Secondary	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
Secondary	Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage	luteinizing hormone	Before, 3 hours , 24 hours and 48 hours after training
Secondary	Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage	Creatine kinase	Before, 3 hours , 24 hours and 48 hours after training
Secondary	Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage	Lactate dehydrogenase	Before, 3 hours , 24 hours and 48 hours after training
Secondary	Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage	Myoglobin	Before, 3 hours , 24 hours and 48 hours after training
Secondary	Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage	Cortisol	Before, 3 hours , 24 hours and 48 hours after training
Secondary	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
Secondary	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
Secondary	Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage	IL-6	Before, 3 hours , 24 hours and 48 hours after training