Menstrual CycleNCT04024826
Effects of Resistance Training on Substrate Metabolism During the Menstrual Cycle
A study testing EFP, LFP and ELP in people with Menstrual Cycle and Substrate Metabolism, run by Southern Illinois University Edwardsville at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstrual Cycle, Substrate Metabolism
- What is being tested?
- EFP, LFP and ELP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 16 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- • Musculoskeletal injuries,
- cardio-respiratory conditions,
- metabolic conditions,
- irregular menstrual cycle,
- menstrual dysfunction or unusual sex hormone levels,
- on contraceptives,
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Southern Illinois University Edwardsville
Edwardsville, Illinois, 62026
About this study
Official title: Acute Effects of Resistance Training on Substrate Metabolism During Different Phases of Menstrual Cycle
This research project's objective is to investigate substrate metabolism behavior in response to the RT during different phases of the menstrual cycle.
Read the 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.
- Conditions
- Menstrual Cycle, Substrate Metabolism
- Being tested
- EFP, LFP, ELP, LLP
- Keywords
- resistance training, carbohydrate metabolism, fat oxidation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EFPBehavioural
This group will perform the Resistance training intervention on day 4 of the menstrual cycle, which corresponds to the mid of early follicular phase.
LFPBehavioural
This group will perform the Resistance training intervention on day 11 of the menstrual cycle, which corresponds to the mid of late follicular phase.
ELPBehavioural
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
LLPBehavioural
This group will perform the Resistance training intervention on day 21 of the menstrual cycle, which corresponds to the mid of late luteal phase
| Study group | Role | What they receive |
|---|---|---|
| Early Follicular Phase (EFP) | Experimental | This group is comprised of participants at the Early Follicular Phase (EFP) of the menstrual cycle. Receives: Behavioral: EFP |
| Late Follicular Phase | Experimental | This group is comprised of participants at the Late Follicular Phase (LFP) of the menstrual cycle. Receives: Behavioral: LFP |
| Early Luteal Phase | Experimental | This group is comprised of participants at the Early Luteal Phase (ELP) of the menstrual cycle. Receives: Behavioral: ELP |
| Late Luteal Phase | Experimental | This group is comprised of participants at the Late Luteal Phase(LLP) of the menstrual cycle. Receives: Behavioral: LLP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Substrate oxidation
changes in substrate oxidation will be measured using cosmed K5 during the intervention phase
Measured: 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
Measured: 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.
Measured: At baseline: 1 assessment point on each menstrual cycle phase
Secondary outcomes (6)
Muscular strength
Muscular strength will be assessed by one-repetition maximum test on leg press and bench press
Measured: At baseline: 1 assessment point
Cardiorespiratory Function
maximal oxygen consumption will measured on a treadmill with a metabolic cart
Measured: 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
Measured: 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
Measured: 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
Measured: At baseline: 1 assessment point
Diet
Diet will be measured using ASA-24h recall
Measured: At baseline: 1 assessment point on each menstrual cycle phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start1 Jul 2019
- Primary completion16 Mar 2020
- Study completion16 Mar 2020
Why it stopped: Covid/19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual CycleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern Illinois University Edwardsville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Fernandez del Valle, PhD, Principal investigator, Southern Illinois University Edwardsville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04024826
- Sponsor's protocol ID
- 111A
- Status last verified
- Jul 2019
- First submitted
- 21 Mar 2019
- Last updated
- 4 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Resistance Training on Substrate Metabolism During Different Phases of Menstrual Cycle
- ClinicalTrials.gov ID
- NCT04024826
- Acronym / sponsor ID
- 111A
- Conditions
- Menstrual Cycle, Substrate Metabolism
- Keywords
- resistance training, carbohydrate metabolism, fat oxidation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Covid/19
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Southern Illinois University EdwardsvilleUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 16 Mar 2020 (actual)
- Study completion
- 16 Mar 2020 (actual)
- First posted
- 18 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Early Follicular Phase (EFP) | Experimental | Behavioral: EFPThis group is comprised of participants at the Early Follicular Phase (EFP) of the menstrual cycle. |
| Late Follicular Phase | Experimental | Behavioral: LFPThis group is comprised of participants at the Late Follicular Phase (LFP) of the menstrual cycle. |
| Early Luteal Phase | Experimental | Behavioral: ELPThis group is comprised of participants at the Early Luteal Phase (ELP) of the menstrual cycle. |
| Late Luteal Phase | Experimental | Behavioral: LLPThis group is comprised of participants at the Late Luteal Phase(LLP) of the menstrual cycle. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- • Musculoskeletal injuries,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EFPThis group will perform the Resistance training intervention on day 4 of the menstrual cycle, which corresponds to the mid of early follicular phase. | Behavioural | Early Follicular Phase (EFP) |
| LFPThis group will perform the Resistance training intervention on day 11 of the menstrual cycle, which corresponds to the mid of late follicular phase. | Behavioural | Late Follicular Phase |
| ELPThis group will perform the Resistance training intervention on the day 18 of the menstrual cycle, which corresponds to the mid of early luteal phase | Behavioural | Early Luteal Phase |
| LLPThis group will perform the Resistance training intervention on day 21 of the menstrual cycle, which corresponds to the mid of late luteal phase | Behavioural | Late Luteal Phase |
Primary outcome
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
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
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.
6 secondary outcomes
Muscular strength
Time frame: At baseline: 1 assessment point
Cardiorespiratory Function
Time frame: At baseline: 1 assessment point
Relative Body Fat (%)
Time frame: At baseline: 1 assessment point
Lean Body Mass (kg)
Time frame: At baseline: 1 assessment point
Fat Mass (kg)
Time frame: At baseline: 1 assessment point
Diet
Time frame: At baseline: 1 assessment point on each menstrual cycle phase
Results and safety
The study was stopped early (reason given: Covid/19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Fernandez del Valle, PhD principal investigator
Southern Illinois University Edwardsville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EFP, LFP and ELP in people with Menstrual Cycle and Substrate Metabolism, run by Southern Illinois University Edwardsville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Covid/19). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Substrate oxidation (time frame: During each exercise session: 1 assessment point on each menstrual cycle phase). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2021.