Effects of Resistance Training on Substrate Metabolism During the Menstrual Cycle

• Sponsor: Southern Illinois University Edwardsville (Other)
• Overall Status: Terminated
• CT.gov ID: NCT04024826
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arms: 4
• Actual Duration (Months): 8.5
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 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.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
• Actual Study Start Date: Jul 1, 2019
• Actual Primary Completion Date: Mar 16, 2020
• Actual Study Completion Date: Mar 16, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Changes in Substrate oxidation [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. [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. [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 [At baseline: 1 assessment point]

   Muscular strength will be assessed by one-repetition maximum test on leg press and bench press

2. Cardiorespiratory Function [At baseline: 1 assessment point]

   maximal oxygen consumption will measured on a treadmill with a metabolic cart

3. Relative Body Fat (%) [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) [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) [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 [At baseline: 1 assessment point on each menstrual cycle phase]

   Diet will be measured using ASA-24h recall

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Southern Illinois University Edwardsville	Edwardsville	Illinois	United States	62026

Sponsors and Collaborators

• Southern Illinois University Edwardsville

Investigators

• Principal Investigator: Maria Fernandez del Valle, PhD, Southern Illinois University Edwardsville

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Southern Illinois University Edwardsville
• ClinicalTrials.gov Identifier: NCT04024826
• Other Study ID Numbers: 111A
• First Posted: Jul 18, 2019
• Last Update Posted: Oct 4, 2021
• Last Verified: Jul 1, 2019

• 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

Study Results

No Results Posted as of Oct 4, 2021