- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06744517
Influence of Menstrual Cycle Phase on Adaptations to Sprint Interval Training
Influence of Menstrual Cycle Phase on Metabolic and Performance Adaptations to Sprint Interval Training
Study Overview
Detailed Description
The primary purpose of the present study is to determine if menstrual cycle phase influences adaptations to 2 weeks of sprint interval training. Participants will be randomized to perform 6 sessions of sprint interval training over 2 weeks in either the Follicular Phase or Luteal Phase of their individual menstrual cycle. Blood and urine sampling will be used to confirm menstrual cycle phases. Training will involve 4-6 x 30-second Wingate sprints with 4 minutes of rest in between (~14-28 min per session). Before and after the training intervention, investigators will measure participant's aerobic and anaerobic performance, cardiorespiratory fitness and skeletal muscle outcomes. Performance and fitness measures are performed on on a stationary bike, and muscle outcomes are measured by taking a small amount of muscle from the vastus lateralis (thigh) muscle.
This study will advance knowledge on how the menstrual cycle influences adaptations to training in females
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jenna Gillen Assistant Professor, PhD
- Phone Number: 4169783244
- Email: jenna.gillen@utoronto.ca
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5S 2C9
- Recruiting
- Goldring Centre for High Performance Sport
-
Contact:
- Jenna Gillen
- Phone Number: 4169783244
- Email: jenna.gillen@utoronto.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participating in 150 min of moderate-vigorous physical activity/week
- VO2peak of 'good' or above based on American College of Sport Medicine (ACSM) normative values(greater than 35.0ml/kg/min)
- Body mass index (BMI) between 18-27 kg/m2
- Performing 2-4 structured exercise sessions/week.
- Weight stable (within ± 2kg for at least 6 months)
- Non-smoker
- Menstrual cycle length of 27-35 days
- Minimal menstrual cycle length variability (less than 3 days)
- Ovulating monthly evidenced by a positive urinary luteinizing hormone surge
- Blood progesterone concentration greater than 16 nmol/L.
Exclusion Criteria:
- Hormonal contraceptive use within the last 3 months
- Polycystic ovarian syndrome (PCOS) or endometriosis
- Failure to meet MC verification criteria.
- Diagnosed with cardiovascular or metabolic disease, hyper- or hypogonadism, and/or PCOS
- The use of medication for managing blood glucose or lipid metabolism
- Current use of oral contraceptives or use within the last 3 months
- Irregular menstrual cycles (<27 days or >35 days)
- Pregnant or post-partum in the last 12 months, lactating or breast feeding within 3 months of the start of study, or menopausal
- Recreational smoking tobacco
- Inability to perform the study exercise protocols or follow the pre-trial dietary or physical activity controls
- Taking medications affecting substrate metabolism (corticosteroids or nSAIDs)
- Actively engaging in a low-carbohydrate diet (e.g., ketogenic, Atkins)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Follicular Phase Training
Exercise training in the follicular phase (~days 1-14) of the participant's menstrual cycle
|
6 sessions of sprint interval training over 2 weeks.
Each session involves 4-6 x 30 second Wingate sprints with 4 minutes of recovery in between on a stationary bike
|
|
Experimental: Luteal Phase Training
Exercise training in the luteal phase (~days 15-28) of the participant's menstrual cycle
|
6 sessions of sprint interval training over 2 weeks.
Each session involves 4-6 x 30 second Wingate sprints with 4 minutes of recovery in between on a stationary bike
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Endurance performance
Time Frame: Before and after 2 weeks of exercise training
|
Time to completion and average power output during a 250kJ time trial
|
Before and after 2 weeks of exercise training
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Skeletal muscle mitochondrial content
Time Frame: Before and after 2 weeks of exercise training
|
Measured via Western blotting
|
Before and after 2 weeks of exercise training
|
|
Skeletal muscle mitochondrial enzyme activity
Time Frame: Before and after 2 weeks of exercise training
|
Measured via enzyme activity assays
|
Before and after 2 weeks of exercise training
|
|
Skeletal muscle capillarization
Time Frame: Before and after 2 weeks of exercise training
|
Measured via immunofluorescence
|
Before and after 2 weeks of exercise training
|
|
Skeletal muscle lipid content
Time Frame: Before and after 2 weeks of exercise training
|
Measured via immunofluorescence
|
Before and after 2 weeks of exercise training
|
|
Skeletal muscle protein synthesis
Time Frame: Before and after 2 weeks of exercise training
|
Measured via the incorporation of a stable isotope tracer during the 2 weeks of training
|
Before and after 2 weeks of exercise training
|
|
Cardiorespiratory fitness
Time Frame: Before and after 2 weeks of exercise training
|
Measured via a maximal exercise test on a cycle ergometer
|
Before and after 2 weeks of exercise training
|
|
Anaerobic exercise performance
Time Frame: Before and after 2 weeks of exercise training
|
Power output during a Wingate anaerobic test
|
Before and after 2 weeks of exercise training
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSREB50581
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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