The Influence of Oral Contraceptive Use on Muscle Recovery (OC-R)

Influence of Oral Contraceptive Use on Recovery in Trained Women

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.

Study Overview

• Status: Completed
• Conditions: Recovery; Oral Contraceptive Use
• Intervention / Treatment: Procedure: Training

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8000
    • Aarhus University, Department for Public Health, Section for Sport Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral contraceptive users	Procedure: Training; Both groups will perform a standardized training protocol
Active Comparator: Non-oral contraceptive users	Procedure: Training; Both groups will perform a standardized training protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Jumping performance	Jump height	Before, 3 hours , 24 hours and 48 hours after training.
Changes in Jumping performance	Power	Before, 3 hours , 24 hours and 48 hours after training.
Changes in Jumping performance	modified reactive strength index	Before, 3 hours , 24 hours and 48 hours after training.
Changes in Jumping performance	leg stiffness	Before, 3 hours , 24 hours and 48 hours after training.
Changes in Wingate performance	Peak power and average power	Before, 3 hours , 24 hours and 48 hours after training.
Changes in Yoyo-intermittent recovery 1 performance	total length covered in the yo-yo test	Before, and 48 hours after training.
Changes in Leg press performance	Total reps performed at 80% of 1RM	Before, 3 hours , 24 hours and 48 hours after training.
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.
Differences in knee laxity	Measured with a Lachmeter	Baseline
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
Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage	estradiol	Before, 3 hours , 24 hours and 48 hours after training
Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage	testosterone	Before, 3 hours , 24 hours and 48 hours after training
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
Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage	progesterone	Before, 3 hours , 24 hours and 48 hours after training
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
Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage	luteinizing hormone	Before, 3 hours , 24 hours and 48 hours after training
Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage	Creatine kinase	Before, 3 hours , 24 hours and 48 hours after training
Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage	Lactate dehydrogenase	Before, 3 hours , 24 hours and 48 hours after training
Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage	Myoglobin	Before, 3 hours , 24 hours and 48 hours after training
Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage	Cortisol	Before, 3 hours , 24 hours and 48 hours after training
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
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
Blood analysis: Sex hormones, cortisol, inflammatory markers and markers of muscle damage	IL-6	Before, 3 hours , 24 hours and 48 hours after training

Collaborators and Investigators

• Sponsor: University of Aarhus

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2020
• Primary Completion (Actual): September 27, 2022
• Study Completion (Actual): September 27, 2023

Study Registration Dates

• First Submitted: September 21, 2020
• First Submitted That Met QC Criteria: September 21, 2020
• First Posted (Actual): September 25, 2020

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: OC-R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No