Clinical trial NCT04024826: Effects of Resistance Training on Substrate Metabolism During the Menstrual Cycle
Official title: Acute Effects of Resistance Training on Substrate Metabolism During Different Phases of Menstrual Cycle
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Menstrual Cycle
Substrate Metabolism
Keywords: resistance training
carbohydrate metabolism
fat oxidation
Lead sponsor: Southern Illinois University Edwardsville
Sponsor class: OTHER
First posted: 2019-07-18
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Changes in Substrate oxidation
timeFrame: During each exercise session: 1 assessment point on each menstrual cycle phase
measure: Changes in Estrogen levels.
timeFrame: At baseline: 1 assessment point on each menstrual cycle phase
measure: Changes in Progesterone levels.
timeFrame: At baseline: 1 assessment point on each menstrual cycle phase
Secondary outcomes:
measure: Muscular strength
timeFrame: At baseline: 1 assessment point
measure: Cardiorespiratory Function
timeFrame: At baseline: 1 assessment point
measure: Relative Body Fat (%)
timeFrame: At baseline: 1 assessment point
measure: Lean Body Mass (kg)
timeFrame: At baseline: 1 assessment point
measure: Fat Mass (kg)
timeFrame: At baseline: 1 assessment point
measure: Diet
timeFrame: At baseline: 1 assessment point on each menstrual cycle phase
Other outcomes:
Locations:
city: Edwardsville
country: United States
facility: Southern Illinois University Edwardsville
state: Illinois
Study officials:
affiliation: Southern Illinois University Edwardsville
name: Maria Fernandez del Valle, PhD
role: PRINCIPAL_INVESTIGATOR
References: