Effects of Resistance Training on Substrate Metabolism During the Menstrual Cycle

Study Overview
=================
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.

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.

Official Title
-----------------
Acute Effects of Resistance Training on Substrate Metabolism During Different Phases of Menstrual Cycle

Conditions
-----------------
Menstrual Cycle, Substrate Metabolism

Intervention / Treatment
-----------------
* Behavioral: EFP
* Behavioral: LFP
* Behavioral: ELP
* Behavioral: LLP


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Follicular Phase (EFP)<br>This group is comprised of participants at the Early Follicular Phase (EFP) of the menstrual cycle. | Behavioral: EFP<br>* This group will perform the Resistance training intervention on day 4 of the menstrual cycle, which corresponds to the mid of early follicular phase.<br>|
| Experimental: Late Follicular Phase<br>This group is comprised of participants at the Late Follicular Phase (LFP) of the menstrual cycle. | Behavioral: LFP<br>* This group will perform the Resistance training intervention on day 11 of the menstrual cycle, which corresponds to the mid of late follicular phase.<br>|
| Experimental: Early Luteal Phase<br>This group is comprised of participants at the Early Luteal Phase (ELP) of the menstrual cycle. | Behavioral: ELP<br>* 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<br>|
| Experimental: Late Luteal Phase<br>This group is comprised of participants at the Late Luteal Phase(LLP) of the menstrual cycle. | Behavioral: LLP<br>* This group will perform the Resistance training intervention on day 21 of the menstrual cycle, which corresponds to the mid of late luteal phase<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscular strength | Muscular strength will be assessed by one-repetition maximum test on leg press and bench press | At baseline: 1 assessment point | 
| Cardiorespiratory Function | maximal oxygen consumption will measured on a treadmill with a metabolic cart | At baseline: 1 assessment point | 
| 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 | 
| 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 | 
| 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 | 
| Diet | Diet will be measured using ASA-24h recall | At baseline: 1 assessment point on each menstrual cycle phase | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
resistance training, carbohydrate metabolism, fat oxidation