Effects of Resistance Training on Substrate Metabolism During the Menstrual Cycle

NCT04024826 | Terminated DMC

• 1 other identifier: 111A
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Menstrual Cycle; Substrate Metabolism

Keywords

resistance training; carbohydrate metabolism; fat oxidation

Outcome Measures

Primary Outcomes (3)

• Changes in Substrate oxidation

  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.

  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.

  Blood would be drawn from the participants for assessment of hormone Progesterone.

  At baseline: 1 assessment point on each menstrual cycle phase

Secondary Outcomes (6)

• Muscular strength

  At baseline: 1 assessment point

• Cardiorespiratory Function

  At baseline: 1 assessment point

• Relative Body Fat (%)

  At baseline: 1 assessment point

• Lean Body Mass (kg)

  At baseline: 1 assessment point

• Fat Mass (kg)

  At baseline: 1 assessment point

Study Arms (4)

Early Follicular Phase (EFP)

EXPERIMENTAL

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

Behavioral: EFP

Late Follicular Phase

EXPERIMENTAL

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

Behavioral: LFP

Early Luteal Phase

EXPERIMENTAL

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

Behavioral: ELP

Late Luteal Phase

EXPERIMENTAL

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

Behavioral: LLP

Interventions

EFP 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.

Early Follicular Phase (EFP)

LFP 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.

Late Follicular Phase

ELP 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

Early Luteal Phase

LLP 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

Late Luteal Phase

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Females with a normal menstrual cycle defined as 28-30 days and a duration of 3-7 days with BMI-18.5-34.99 and between 18-45 years.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Southern Illinois University Edwardsville: lead

Study Sites (1)

Southern Illinois University Edwardsville

Edwardsville, Illinois, 62026, United States

Location

Study Officials

• Maria Fernandez del Valle, PhD

  Southern Illinois University Edwardsville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 21, 2019
• First Posted: July 18, 2019
• Study Start: July 1, 2019
• Primary Completion: March 16, 2020
• Study Completion: March 16, 2020
• Last Updated: October 4, 2021

Record last verified: 2019-07

Locations

US (1)