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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04024826
Other study ID # 111A
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date July 1, 2019
Est. completion date March 16, 2020

Study information

Verified date July 2019
Source Southern Illinois University Edwardsville
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Terminated
Enrollment 10
Est. completion date March 16, 2020
Est. primary completion date March 16, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.
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
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

Locations

Country Name City State
United States Southern Illinois University Edwardsville Edwardsville Illinois

Sponsors (1)

Lead Sponsor Collaborator
Southern Illinois University Edwardsville

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 Muscular strength Muscular strength will be assessed by one-repetition maximum test on leg press and bench press At baseline: 1 assessment point
Secondary Cardiorespiratory Function maximal oxygen consumption will measured on a treadmill with a metabolic cart At baseline: 1 assessment point
Secondary Relative Body Fat (%) 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
Secondary Lean Body Mass (kg) 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
Secondary Fat Mass (kg) 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
Secondary Diet Diet will be measured using ASA-24h recall At baseline: 1 assessment point on each menstrual cycle phase
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