- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04024826
Effects of Resistance Training on Substrate Metabolism During the Menstrual Cycle
September 27, 2021 updated by: Southern Illinois University Edwardsville
Acute Effects of Resistance Training on Substrate Metabolism During Different Phases of Menstrual Cycle
This research project's objective is to investigate substrate metabolism behavior in response to the RT during different phases of the menstrual cycle.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
Based on the literature the investigators hypothesize an increase in fat oxidation in early follicular phase(EFP) and late follicular phase (LFP) when compared to early luteal phase (ELP) and late luteal phase (LLP).
Given the lack of research in exercise and menstrual cycle - especially in resistance training - results are uncertain unless the investigators base their hypotheses only on the general physiological effects of sex hormones (without exercise).
In this case, the investigators expect to see a reduced carbohydrate utilization and an increased utilization of fats in EFP and LFP.
In addition, the intervention is focused on muscular endurance and, therefore, it is expected to see a higher reliance on aerobic pathways.
It is expected that the effects of the intervention will be added to the effects of estrogens, with increasing fat oxidation when estrogen levels are higher.
Lastly, a comparison of fat oxidation levels obtained on each sub-phase would reveal if there are differences in the magnitude of the effect of distinct concentrations of estrogen and progesterone.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Illinois
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Edwardsville, Illinois, United States, 62026
- Southern Illinois University Edwardsville
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Females with BMI-18.5-34.99 and between 18-45 years, with normal menstrual cycle defined as 28-30 days cycles +-3 days.
- Including higher BMI participants might alter the results as increased body fat has been linked to changes in different hormonal levels (not only sex hormones) and that might influence substrate utilization.
- Sedentary .or physically active for 2 days a week or less.
Exclusion Criteria:
• Musculoskeletal injuries,
- cardio-respiratory conditions,
- metabolic conditions,
- irregular menstrual cycle,
- menstrual dysfunction or unusual sex hormone levels,
- on contraceptives,
- on medication that alter hormonal or cardio-respiratory responses,
- pre-menopausal symptoms,
- on moderate to high-intensity exercise regime more than 2d/week.
- All these exclusion criteria are chosen because any one of the listed criteria above can alter the responses and/or affect the safety of the subject during their participation in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Early Follicular Phase (EFP)
This group is comprised of participants at the Early Follicular Phase (EFP) of the menstrual cycle.
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This group will perform the Resistance training intervention on day 4 of the menstrual cycle, which corresponds to the mid of early follicular phase.
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Experimental: Late Follicular Phase
This group is comprised of participants at the Late Follicular Phase (LFP) of the menstrual cycle.
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This group will perform the Resistance training intervention on day 11 of the menstrual cycle, which corresponds to the mid of late follicular phase.
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Experimental: Early Luteal Phase
This group is comprised of participants at the Early Luteal Phase (ELP) of the menstrual cycle.
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This group will perform the Resistance training intervention on the day 18 of the menstrual cycle, which corresponds to the mid of early luteal phase
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Experimental: Late Luteal Phase
This group is comprised of participants at the Late Luteal Phase(LLP) of the menstrual cycle.
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This group will perform the Resistance training intervention on day 21 of the menstrual cycle, which corresponds to the mid of late luteal phase
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Substrate oxidation
Time Frame: During each exercise session: 1 assessment point on each menstrual cycle phase
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changes in substrate oxidation will be measured using cosmed K5 during the intervention phase
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During each exercise session: 1 assessment point on each menstrual cycle phase
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Changes in Estrogen levels.
Time Frame: At baseline: 1 assessment point on each menstrual cycle phase
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Blood would be drawn from the participants for assessment of hormone estrogen
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At baseline: 1 assessment point on each menstrual cycle phase
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Changes in Progesterone levels.
Time Frame: At baseline: 1 assessment point on each menstrual cycle phase
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Blood would be drawn from the participants for assessment of hormone Progesterone.
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At baseline: 1 assessment point on each menstrual cycle phase
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscular strength
Time Frame: At baseline: 1 assessment point
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Muscular strength will be assessed by one-repetition maximum test on leg press and bench press
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At baseline: 1 assessment point
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Cardiorespiratory Function
Time Frame: At baseline: 1 assessment point
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maximal oxygen consumption will measured on a treadmill with a metabolic cart
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At baseline: 1 assessment point
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Relative Body Fat (%)
Time Frame: At baseline: 1 assessment point
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Body composition i.e Fat mass, Lean body mass and Body fat percentage will be measured using dual-energy xray absorptiometry
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At baseline: 1 assessment point
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Lean Body Mass (kg)
Time Frame: At baseline: 1 assessment point
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Body composition i.e Fat mass, Lean body mass and Body fat percentage will be measured using dual-energy xray absorptiometry
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At baseline: 1 assessment point
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Fat Mass (kg)
Time Frame: At baseline: 1 assessment point
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Body composition i.e Fat mass, Lean body mass and Body fat percentage will be measured using dual-energy xray absorptiometry
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At baseline: 1 assessment point
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Diet
Time Frame: At baseline: 1 assessment point on each menstrual cycle phase
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Diet will be measured using ASA-24h recall
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At baseline: 1 assessment point on each menstrual cycle phase
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Maria Fernandez del Valle, PhD, Southern Illinois University Edwardsville
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2019
Primary Completion (Actual)
March 16, 2020
Study Completion (Actual)
March 16, 2020
Study Registration Dates
First Submitted
March 21, 2019
First Submitted That Met QC Criteria
July 17, 2019
First Posted (Actual)
July 18, 2019
Study Record Updates
Last Update Posted (Actual)
October 4, 2021
Last Update Submitted That Met QC Criteria
September 27, 2021
Last Verified
July 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 111A
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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