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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Illinois
      • Edwardsville, Illinois, United States, 62026
        • Southern Illinois University Edwardsville

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Early Follicular Phase (EFP)
This group is comprised of participants at the Early Follicular Phase (EFP) of the menstrual cycle.
Behavioral: EFP
This group will perform the Resistance training intervention on day 4 of the menstrual cycle, which corresponds to the mid of early follicular phase.
Experimental: Late Follicular Phase
This group is comprised of participants at the Late Follicular Phase (LFP) of the menstrual cycle.
Behavioral: LFP
This group will perform the Resistance training intervention on day 11 of the menstrual cycle, which corresponds to the mid of late follicular phase.
Experimental: Early Luteal Phase
This group is comprised of participants at the Early Luteal Phase (ELP) of the menstrual cycle.
Behavioral: ELP
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
Experimental: Late Luteal Phase
This group is comprised of participants at the Late Luteal Phase(LLP) of the menstrual cycle.
Behavioral: LLP
This group will perform the Resistance training intervention on day 21 of the menstrual cycle, which corresponds to the mid of late luteal phase

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in Substrate oxidation
Time Frame: During each exercise session: 1 assessment point on each menstrual cycle phase
changes in substrate oxidation will be measured using cosmed K5 during the intervention phase
During each exercise session: 1 assessment point on each menstrual cycle phase
Changes in Estrogen levels.
Time Frame: At baseline: 1 assessment point on each menstrual cycle phase
Blood would be drawn from the participants for assessment of hormone estrogen
At baseline: 1 assessment point on each menstrual cycle phase
Changes in Progesterone levels.
Time Frame: At baseline: 1 assessment point on each menstrual cycle phase
Blood would be drawn from the participants for assessment of hormone Progesterone.
At baseline: 1 assessment point on each menstrual cycle phase

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Muscular strength
Time Frame: At baseline: 1 assessment point
Muscular strength will be assessed by one-repetition maximum test on leg press and bench press
At baseline: 1 assessment point
Cardiorespiratory Function
Time Frame: At baseline: 1 assessment point
maximal oxygen consumption will measured on a treadmill with a metabolic cart
At baseline: 1 assessment point
Relative Body Fat (%)
Time Frame: At baseline: 1 assessment point
Body composition i.e Fat mass, Lean body mass and Body fat percentage will be measured using dual-energy xray absorptiometry
At baseline: 1 assessment point
Lean Body Mass (kg)
Time Frame: At baseline: 1 assessment point
Body composition i.e Fat mass, Lean body mass and Body fat percentage will be measured using dual-energy xray absorptiometry
At baseline: 1 assessment point
Fat Mass (kg)
Time Frame: At baseline: 1 assessment point
Body composition i.e Fat mass, Lean body mass and Body fat percentage will be measured using dual-energy xray absorptiometry
At baseline: 1 assessment point
Diet
Time Frame: At baseline: 1 assessment point on each menstrual cycle phase
Diet will be measured using ASA-24h recall
At baseline: 1 assessment point on each menstrual cycle phase

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Southern Illinois University Edwardsville

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 16, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 16, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 4, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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