The Influence of Oral Contraceptive Use on Muscle Recovery

NCT04564300 | Completed DMC

• 1 other identifier: OC-R
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Recovery; Oral Contraceptive Use

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (23)

• Changes in Jumping performance

  Before, 3 hours , 24 hours and 48 hours after training.

• Changes in Jumping performance

  Before, 3 hours , 24 hours and 48 hours after training.

• Changes in Jumping performance

  Before, 3 hours , 24 hours and 48 hours after training.

• Changes in Jumping performance

  Before, 3 hours , 24 hours and 48 hours after training.

• Changes in Wingate performance

  Before, 3 hours , 24 hours and 48 hours after training.

Study Arms (2)

Oral contraceptive users

EXPERIMENTAL

Procedure: Training

Non-oral contraceptive users

ACTIVE COMPARATOR

Procedure: Training

Interventions

Training PROCEDURE

Both groups will perform a standardized training protocol

Non-oral contraceptive users; Oral contraceptive users

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

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

Aarhus, 8000, Denmark

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We will compare the recovery in a group of oral contraceptive users to a group of women not using oral contraceptives

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: September 25, 2020
• Study Start: October 19, 2020
• Primary Completion: September 27, 2022
• Study Completion: September 27, 2023
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)