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Completed

NCT Number: NCT04564300

The Influence of Oral Contraceptive Use on Muscle Recovery

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.

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Key information

Conditions

Recovery Oral Contraceptive Use

Age range

18 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University, Department for Public Health, Section for Sport Science

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Training

Procedure

Both groups will perform a standardized training protocol

Primary outcomes

  1. Changes in maximal knee extensor strength and Rate of force development

    Time frame: Before, 3 hours , 24 hours and 48 hours after training

    Measured in a Humac Norm dynamometer

Secondary outcomes

  1. Changes in Jumping performance

    Time frame: Before, 3 hours , 24 hours and 48 hours after training.

    Jump height

  2. Changes in Jumping performance

    Time frame: Before, 3 hours , 24 hours and 48 hours after training.

    Power

  3. Changes in Jumping performance

    Time frame: Before, 3 hours , 24 hours and 48 hours after training.

    modified reactive strength index

  4. Changes in Jumping performance

    Time frame: Before, 3 hours , 24 hours and 48 hours after training.

    leg stiffness

  5. Changes in Wingate performance

    Time frame: Before, 3 hours , 24 hours and 48 hours after training.

    Peak power and average power

  6. Changes in Yoyo-intermittent recovery 1 performance

    Time frame: Before, and 48 hours after training.

    total length covered in the yo-yo test

  7. Changes in Leg press performance

    Time frame: Before, 3 hours , 24 hours and 48 hours after training.

    Total reps performed at 80% of 1RM

  8. Changes training volume

    Time frame: Before, 3 hours , 24 hours and 48 hours after training.

    total volume performed during training (i.e set x reps x working weight)

  9. Differences in knee laxity

    Time frame: Baseline

    Measured with a Lachmeter

  10. Changes in muscle soreness (VAS-score)

    Time frame: Before, 3 hours , 24 hours and 48 hours after training

    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.)

  11. Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage

    Time frame: Before, 3 hours , 24 hours and 48 hours after training

    estradiol

  12. Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage

    Time frame: Before, 3 hours , 24 hours and 48 hours after training

    testosterone

  13. Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage

    Time frame: Before, 3 hours , 24 hours and 48 hours after training

    sex hormone-binding globulin

  14. Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage

    Time frame: Before, 3 hours , 24 hours and 48 hours after training

    progesterone

  15. Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage

    Time frame: Before, 3 hours , 24 hours and 48 hours after training

    follicle-stimulating hormone

  16. Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage

    Time frame: Before, 3 hours , 24 hours and 48 hours after training

    luteinizing hormone

  17. Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage

    Time frame: Before, 3 hours , 24 hours and 48 hours after training

    Creatine kinase

  18. Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage

    Time frame: Before, 3 hours , 24 hours and 48 hours after training

    Lactate dehydrogenase

  19. Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage

    Time frame: Before, 3 hours , 24 hours and 48 hours after training

    Myoglobin

  20. Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage

    Time frame: Before, 3 hours , 24 hours and 48 hours after training

    Cortisol

  21. Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage

    Time frame: Before, 3 hours , 24 hours and 48 hours after training

    C-reactive protein

  22. Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage

    Time frame: Before, 3 hours , 24 hours and 48 hours after training

    tumor necrosis factor

  23. Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage

    Time frame: Before, 3 hours , 24 hours and 48 hours after training

    IL-6

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

Influence of Oral Contraceptive Use on Recovery in Trained Women

Acronym: OC-R

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Sep 25, 2020
Registry last updated
May 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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