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Effects of Resistance Training on Substrate Metabolism During the Menstrual Cycle

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ClinicalTrials.gov Identifier: NCT04024826
Recruitment Status : Recruiting
First Posted : July 18, 2019
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Southern Illinois University Edwardsville

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.

Condition or disease Intervention/treatment Phase
Menstrual Cycle Substrate Metabolism Behavioral: EFP Behavioral: LFP Behavioral: ELP Behavioral: LLP Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Acute Effects of Resistance Training on Substrate Metabolism During Different Phases of Menstrual Cycle
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menstruation

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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.


Secondary Outcome Measures :
  1. 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

  2. Cardiorespiratory Function [ Time Frame: At baseline: 1 assessment point ]
    maximal oxygen consumption will measured on a treadmill with a metabolic cart

  3. 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

  4. 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

  5. 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

  6. Diet [ Time Frame: At baseline: 1 assessment point on each menstrual cycle phase ]
    Diet will be measured using ASA-24h recall



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   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.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Females with BMI-18.5-34.99 and between 18-45 years, a normal menstrual cycle defined approximately 28-30 days and a duration of 3-7 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 less than 2 days/week.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04024826


Contacts
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Contact: Maria Fernandez del Valle, PhD 6186505905 marfern@siue.edu

Locations
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United States, Illinois
Southern Illinois University Edwardsville Recruiting
Edwardsville, Illinois, United States, 62026
Contact: Huaibo Xin, DrPH    618-650-3226    hxin@siue.edu   
Sponsors and Collaborators
Southern Illinois University Edwardsville
Investigators
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Principal Investigator: Maria Fernandez del Valle, PhD Southern Illinois University Edwardsville

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Responsible Party: Southern Illinois University Edwardsville
ClinicalTrials.gov Identifier: NCT04024826     History of Changes
Other Study ID Numbers: 111A
First Posted: July 18, 2019    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Southern Illinois University Edwardsville:
resistance training
carbohydrate metabolism
fat oxidation