Effects of Resistance Training on Substrate Metabolism During the Menstrual Cycle

NCT ID: NCT04024826

Last Updated: 2021-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2020-03-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This research project's objective is to investigate substrate metabolism behavior in response to the RT during different phases of the menstrual cycle.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Menstrual Cycle Substrate Metabolism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

The participants will be randomized into either one of the 4 four phases- namely Early Follicular Phase(EFP-Days1 to 7), Late Follicular Phase(LFP-Days 8 to 14), Early Luteal Phase(ELP-Days 15 to 21) or Late Luteal Phase(LLP-Days 22 to 28) of the menstrual phase. Once the participant is assigned to one of the phases. Each participant will undergo 4 intervention days. the first intervention day will take place during the mid-point of the said phase i.e. EFP- Day 4. After one intervention is complete there will be a washout period and the intervention will take place on the 7th day after the first intervention i.e if the first intervention is LFP done on day 11 of the menstrual cycle the next intervention will take place on day 18 of menstrual cycle which will account for ELP. In this manner, the Participant will be tested in all 4 phases.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Early Follicular Phase (EFP)

This group is comprised of participants at the Early Follicular Phase (EFP) of the menstrual cycle.

Group Type EXPERIMENTAL

EFP

Intervention Type BEHAVIORAL

This group will perform the Resistance training intervention on day 4 of the menstrual cycle, which corresponds to the mid of early follicular phase.

Late Follicular Phase

This group is comprised of participants at the Late Follicular Phase (LFP) of the menstrual cycle.

Group Type EXPERIMENTAL

LFP

Intervention Type BEHAVIORAL

This group will perform the Resistance training intervention on day 11 of the menstrual cycle, which corresponds to the mid of late follicular phase.

Early Luteal Phase

This group is comprised of participants at the Early Luteal Phase (ELP) of the menstrual cycle.

Group Type EXPERIMENTAL

ELP

Intervention Type BEHAVIORAL

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

Late Luteal Phase

This group is comprised of participants at the Late Luteal Phase(LLP) of the menstrual cycle.

Group Type EXPERIMENTAL

LLP

Intervention Type BEHAVIORAL

This group will perform the Resistance training intervention on day 21 of the menstrual cycle, which corresponds to the mid of late luteal phase

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type 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

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Southern Illinois University Edwardsville

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Maria Fernandez del Valle, PhD

Role: PRINCIPAL_INVESTIGATOR

Southern Illinois University Edwardsville

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Southern Illinois University Edwardsville

Edwardsville, Illinois, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

111A

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Menstrual Cycle and Exercise-induced Muscle Damage
NCT07322874 ACTIVE_NOT_RECRUITING NA
SubsTRate OxidatioN in Girls
NCT04483921 COMPLETED NA