The Influence of Oral Contraceptive Use on Muscle Recovery

NCT ID: NCT04564300

Last Updated: 2024-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-19
• Study Completion Date: 2023-09-27

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Oral contraceptive users

Group Type: EXPERIMENTAL

Training

Intervention Type: PROCEDURE

Both groups will perform a standardized training protocol

Non-oral contraceptive users

Group Type: ACTIVE_COMPARATOR

Training

Intervention Type: PROCEDURE

Both groups will perform a standardized training protocol

Interventions

Training

Both groups will perform a standardized training protocol

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Aarhus, , Denmark

Countries

Denmark

Other Identifiers

OC-R

Identifier Type: -

Identifier Source: org_study_id