Menstruation DisturbancesBioENCT04938622
Bioenergetics of Exercise-Induced Menstrual Disturbances
A study testing 15 percent energy deficit, 30 percent energy deficit and 30 percent energy deficit (15/15) in people with Menstruation Disturbances and Luteal Phase Defect, run by Penn State University.
Trial summary
Menstrual disturbances are frequently observed in physically active women and female athletes. Short term prospective studies have shown that diet and exercise interventions can lead to decreases in Luteinizing hormone (LH) pulsatility, however these studies are unable to capture further changes in menstrual status. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstruation Disturbances, Luteal Phase Defect, Amenorrhea
- What is being tested?
- 15 percent energy deficit, 30 percent energy deficit and 30 percent energy deficit (15/15)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2001to 30 Apr 2005
- 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 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Weight 45-75 kg
- Body fat 15-35 percent
- BMI 18-25 kg/m2
- Nonsmoking
- <1 hour/week of purposeful aerobic exercise for the past 6 months
- Documentation of at least two ovulatory menstrual cycles during screening.
Who cannot join
- History of serious medical conditions
- Medication use that would alter metabolic hormone levels
- Significant weight loss/gain (±2.3 kg) in the last year
- Current evidence of disordered eating or history of an eating disorder
- Taking exogenous hormonal contraceptives for the past 6 months
About this study
Menstrual disturbances are frequently observed in physically active women and female athletes. Short term prospective studies have shown that diet and exercise interventions can lead to decreases in Luteinizing hormone (LH) pulsatility, however these studies are unable to capture further changes in menstrual status. One longer term prospective study over two menstrual cycles showed that weight loss elicited menstrual disturbances, but there were no quantifiable measurements of energy availability. Thus, the primary purpose of this study was to assess how varying levels of energy deficiency created through a combination of caloric restriction and exercise affect menstrual function in young, premenopausal, sedentary women.
Read the detailed description
Long term energy deficiency in women can lead to functional hypothalamic amenorrhea (FHA), which can cause many health detriments such as osteopenia, stress fractures, transient infertility, dyslipidemia, and impaired endothelial function. Though studies involving diet and exercise interventions have shown how energy deficiency can lead to menstrual disturbances prospectively, this study aims to extend those findings by measuring the magnitude of energy deficit that could lead to these disturbances. Hypotheses for this study are: 1) there would be a dose-response relation between the induction of menstrual disturbances (luteal phase defects, anovulation, and oligomenorrhea) and the magnitude of energy deficiency such that the intervention groups experiencing a greater energy deficit would incur a significantly greater incidence of menstrual cycle disturbances and 2) the intervention groups experiencing a greater energy deficit would incur a greater incidence of more severe menstrual cycle disturbances.
The study included one baseline menstrual cycle and 3 intervention menstrual cycles. During the baseline period, participants were randomly assigned to an experimental group for intervention menstrual cycles 1, 2, and 3 of the study. The goal of the subject groupings was to test the impact of varying levels of an energy deficit created by the combination of caloric restriction and exercise on menstrual function. They were assigned to either a control group that did not exercise and consumed a number of calories estimated to maintain body weight, a control group that exercised but received extra food calories to remain in energy balance (EXCON), or one of four groups that exercised and were prescribed reduced energy intake to create varying levels of an energy deficit. Specifically, the four groups of energy deficit were 1) an increase of 15 percent kcal of exercise (15 percent deficit, ED1), 2) an increase of 30 percent kcal of exercise (30 percent deficit, ED2), 3) a decrease of 15 percent in dietary intake combined with an increase of 15 percent of exercise, (30 percent deficit 15/15, ED2), and 4) a decrease of 30 percent in dietary intake combined with an increase of 30 percent kcal of exercise (60 percent deficit, ED3). The number of participants for analysis was 34 participants in the following groups: EXCON (n = 8), ED1 (n = 6), ED2 (n = 12), and ED3 (n = 8).
Baseline energy needs were assessed during the baseline cycle. Resting metabolic rate and nonexercise physical activity were added to determine a caloric need for the day. Caloric intake was supervised throughout the entire study, and meals were comprised of 55 percent carbohydrates, 30 percent fat, and 15 percent protein. Exercise training was also supervised, and maximal oxygen consumption (VO2 max) was calculated. Menstrual status was assessed through analysis of daily urinary metabolites of estrone-1-glucuronide (E1G), pregnanediol glucuronide (PdG), and midcycle LH. Underwater weighing and a digital scale were used to assess body composition, and fasting blood samples were collected to assess metabolic hormones.
- Being tested
- Sedentary Control, Exercising control, 15 percent energy deficit, 30 percent energy deficit, 30 percent energy deficit (15/15)
- Keywords
- Energy Balance, Menstrual Cycle Disturbance, Luteal Phase Defect, Amenorrhea, Oligomenorrhea
- Medical subject headings
- Menstruation Disturbances, Amenorrhea, Oligomenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sedentary ControlOther
Also called Diet
Diet: Participants consumed meals in the General Clinical Research Center metabolic kitchen that had calories sufficient to maintain body weight. Diet composition was 55 percent carbohydrates, 30 percent fat, and 15 percent protein.
Exercising controlOther
Also called Diet
Exercise: Participants engaged in supervised exercise training in Noll Laboratory Diet: Participants consumed meals in the General Clinical Research Center metabolic kitchen that had calories sufficient to maintain body weight and additional calories to remain in energy balance. Diet composition was 55 percent carbohydrates, 30 percent fat, and 15 percent protein.
15 percent energy deficitOther
Also called Diet and exercise
Exercise: Participants engaged in supervised exercise training in Noll Laboratory that was equal to 15 percent of the participants' daily caloric needs.
Diet: Participants consumed meals in the General Clinical Research Center metabolic kitchen that had calories to meet metabolic needs (before 15 percent deficit exercise). Diet composition was 55 percent carbohydrates, 30 percent fat, and 15 percent protein.
30 percent energy deficitOther
Also called Diet and exercise
Exercise: Participants engaged in supervised exercise training in Noll Laboratory that was equal to 30 percent of the participants' daily caloric needs.
Diet: Participants consumed meals in the General Clinical Research Center metabolic kitchen that had calories to meet metabolic needs (before 30 percent deficit exercise). Diet composition was 55 percent carbohydrates, 30 percent fat, and 15 percent protein.
30 percent energy deficit (15/15)Other
Also called Diet and exercise
Exercise: Participants engaged in supervised exercise training in Noll Laboratory that was equal to 15 percent of the participants' daily caloric needs.
Diet: Participants consumed meals in the General Clinical Research Center metabolic kitchen that had 15 percent less calories than those needed to meet metabolic needs. Diet composition was 55 percent carbohydrates, 30 percent fat, and 15 percent protein.
60 percent energy deficitOther
Also called Diet and exercise
Exercise: Participants engaged in supervised exercise training in Noll Laboratory that was equal to 30 percent of the participants' daily caloric needs.
Diet: Participants consumed meals in the General Clinical Research Center metabolic kitchen that had 30 percent less calories than those needed to meet metabolic needs. Diet composition was 55 percent carbohydrates, 30 percent fat, and 15 percent protein.
| Study group | Role | What they receive |
|---|---|---|
| Sedentary Control | Experimental | Participants did not exercise but consumed a diet that has an appropriate number of calories to maintain body weight throughout the intervention (3 menstrual cycles). Receives: Other: Sedentary Control |
| Exercising control | Experimental | Participants exercised but were given extra calories to remain in energy balance throughout the intervention (3 menstrual cycles). Receives: Other: Exercising control |
| 15 percent energy deficit (ED1) | Experimental | Participants exercised for the equivalent of 15 percent of their daily caloric intake needs throughout the intervention cycles. Receives: Other: 15 percent energy deficit |
| 30 percent energy deficit (ED2) | Experimental | Participants exercised for the equivalent of 30 percent of their daily caloric intake needs throughout the intervention cycles. Receives: Other: 30 percent energy deficit |
| 30 percent energy deficit 15/15 (ED2) | Experimental | Participants exercised for the equivalent of 15 percent of their daily caloric intake needs throughout the intervention cycles, and their dietary intake was decreased by 15 percent to total a 30 percent energy deficit. Receives: Other: 30 percent energy deficit (15/15) |
| 60 percent energy deficit (ED3) | Experimental | Participants exercised for the equivalent of 30 percent of their daily caloric intake needs throughout the intervention cycles, and their dietary intake was decreased by 30 percent to total a 60 percent energy deficit. Receives: Other: 60 percent energy deficit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in frequency of menstrual disturbances (disturbances /cycle)
Frequency of menstrual disturbances including luteal phase defects, anovulation, oligomenorrhea cycles, and anovulatory cycles analyzed by daily urinary metabolites of estrone-1-glucuronide (E1G), pregnanediol glucuronide (PdG), and midcycle LH
Measured: Baseline Menstrual Cycle (MC) (28 days (d) or the length of 1 MC, intervention MC 1 (28 days or the length of 1 MC), intervention MC 2 (28 days or the length of 1 MC), and intervention MC 3 (28 days or the length of 1 MC)
Secondary outcomes (9)
Change in percent body fat
Change in percent body fat (%)
Measured: Baseline Menstrual Cycle (MC) (28 days (d) or the length of 1 MC, intervention MC 1 (28 days or the length of 1 MC), intervention MC 2 (28 days or the length of 1 MC), and intervention MC 3 (28 days or the length of 1 MC), & Post Study (days 1-7)
Change in metabolic hormones
Change in metabolic hormones total triiodothyronine (T3 ng/dL)) and insulin-like growth factor-1 (IGF-1 ng/ml).
Measured: Baseline Menstrual Cycle (MC) (28 days (d) or the length of 1 MC, Mid- study (week 3 of MC during intervention MC 2) an (28 days (d) or the length of 1 MC), & Post Study (Days (d)1-7 of cycle
Change in cycle length (days (d))
Change in cycle length (days (d))
Measured: Baseline Menstrual Cycle (MC) (28 days (d) or the length of 1 MC, intervention MC 1 (28 days or the length of 1 MC), intervention MC 2 (28 days or the length of 1 MC), and intervention MC 3 (28 days or the length of 1 MC)
Change in aerobic capacity
Change in aerobic capacity, VO2 max (ml/kg/min)
Measured: Baseline Menstrual Cycle (MC) (28 days (d) or the length of 1 MC, & Post Study (Days (d)1-7 of cycle
Change in body weight
Body weight (kg)
Measured: Baseline Menstrual Cycle (MC) (28 days (d) or the length of 1 MC, intervention MC 1 (28 days or the length of 1 MC), intervention MC 2 (28 days or the length of 1 MC), and intervention MC 3 (28 days or the length of 1 MC), & Post Study (days 1-7)
Change in fat mass
Change in fat mass (kg)
Measured: Baseline Menstrual Cycle (MC) (28 days (d) or the length of 1 MC, intervention MC 1 (28 days or the length of 1 MC), intervention MC 2 (28 days or the length of 1 MC), and intervention MC 3 (28 days or the length of 1 MC), & Post Study (days 1-7)
Change in fat free mass
Change in fat free mass (kg)
Measured: Baseline Menstrual Cycle (MC) (28 days (d) or the length of 1 MC, intervention MC 1 (28 days or the length of 1 MC), intervention MC 2 (28 days or the length of 1 MC), and intervention MC 3 (28 days or the length of 1 MC), & Post Study (days 1-7)
Change in follicular phase length
Change in follicular phase length (days (d))
Measured: Baseline Menstrual Cycle (MC) (28 days (d) or the length of 1 MC, intervention MC 1 (28 days or the length of 1 MC), intervention MC 2 (28 days or the length of 1 MC), and intervention MC 3 (28 days or the length of 1 MC)
Change in luteal phase length
Change in luteal phase length (days (d))
Measured: Baseline Menstrual Cycle (MC) (28 days (d) or the length of 1 MC, intervention MC 1 (28 days or the length of 1 MC), intervention MC 2 (28 days or the length of 1 MC), and intervention MC 3 (28 days or the length of 1 MC)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start1 May 2001
- Primary completion30 Apr 2005
- Study completion30 Apr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Menstruation DisturbancesStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Nancy Williams, Penn State University
- Investigators
- Nancy I Williams, ScD, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04938622
- Sponsor's protocol ID
- 990878
- Other IDs
- R01HD039245-01
- Acronym
- BioE
- Status last verified
- Jun 2021
- First submitted
- 1 Jun 2021
- Last updated
- 24 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lieberman JL, DE Souza MJ, Wagstaff DA, Williams NI. Menstrual Disruption with Exercise Is Not Linked to an Energy Availability Threshold. Med Sci Sports Exerc. 2018 Mar;50(3):551-561. doi: 10.1249/MSS.0000000000001451.
PubMed 29023359Williams NI, Leidy HJ, Hill BR, Lieberman JL, Legro RS, De Souza MJ. Magnitude of daily energy deficit predicts frequency but not severity of menstrual disturbances associated with exercise and caloric restriction. Am J Physiol Endocrinol Metab. 2015 Jan 1;308(1):E29-39. doi: 10.1152/ajpendo.00386.2013. Epub 2014 Oct 28.
PubMed 25352438
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioenergetics of Exercise-Induced Menstrual Disturbances
- ClinicalTrials.gov ID
- NCT04938622
- Acronym / sponsor ID
- BioE / 990878
- Keywords
- Energy Balance, Menstrual Cycle Disturbance, Luteal Phase Defect, Amenorrhea, Oligomenorrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 May 2001 (actual)
- Primary completion
- 30 Apr 2005 (actual)
- Study completion
- 30 Apr 2005 (actual)
- First posted
- 24 Jun 2021 (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.
Menstrual disturbances are frequently observed in physically active women and female athletes. Short term prospective studies have shown that diet and exercise interventions can lead to decreases in Luteinizing hormone (LH) pulsatility, however these studies are unable to capture further changes in menstrual status. One longer term prospective study over two menstrual cycles showed that weight loss elicited menstrual disturbances, but there were no quantifiable measurements of energy availability. Thus, the primary purpose of this study was to assess how varying levels of energy deficiency created through a combination of caloric restriction and exercise affect menstrual function in young, premenopausal, sedentary women.
Detailed description
Long term energy deficiency in women can lead to functional hypothalamic amenorrhea (FHA), which can cause many health detriments such as osteopenia, stress fractures, transient infertility, dyslipidemia, and impaired endothelial function. Though studies involving diet and exercise interventions have shown how energy deficiency can lead to menstrual disturbances prospectively, this study aims to extend those findings by measuring the magnitude of energy deficit that could lead to these disturbances. Hypotheses for this study are: 1) there would be a dose-response relation between the induction of menstrual disturbances (luteal phase defects, anovulation, and oligomenorrhea) and the magnitude of energy deficiency such that the intervention groups experiencing a greater energy deficit would incur a significantly greater incidence of menstrual cycle disturbances and 2) the intervention groups experiencing a greater energy deficit would incur a greater incidence of more severe menstrual cycle disturbances.
The study included one baseline menstrual cycle and 3 intervention menstrual cycles. During the baseline period, participants were randomly assigned to an experimental group for intervention menstrual cycles 1, 2, and 3 of the study. The goal of the subject groupings was to test the impact of varying levels of an energy deficit created by the combination of caloric restriction and exercise on menstrual function. They were assigned to either a control group that did not exercise and consumed a number of calories estimated to maintain body weight, a control group that exercised but received extra food calories to remain in energy balance (EXCON), or one of four groups that exercised and were prescribed reduced energy intake to create varying levels of an energy deficit. Specifically, the four groups of energy deficit were 1) an increase of 15 percent kcal of exercise (15 percent deficit, ED1), 2) an increase of 30 percent kcal of exercise (30 percent deficit, ED2), 3) a decrease of 15 percent in dietary intake combined with an increase of 15 percent of exercise, (30 percent deficit 15/15, ED2), and 4) a decrease of 30 percent in dietary intake combined with an increase of 30 percent kcal of exercise (60 percent deficit, ED3). The number of participants for analysis was 34 participants in the following groups: EXCON (n = 8), ED1 (n = 6), ED2 (n = 12), and ED3 (n = 8).
Baseline energy needs were assessed during the baseline cycle. Resting metabolic rate and nonexercise physical activity were added to determine a caloric need for the day. Caloric intake was supervised throughout the entire study, and meals were comprised of 55 percent carbohydrates, 30 percent fat, and 15 percent protein. Exercise training was also supervised, and maximal oxygen consumption (VO2 max) was calculated. Menstrual status was assessed through analysis of daily urinary metabolites of estrone-1-glucuronide (E1G), pregnanediol glucuronide (PdG), and midcycle LH. Underwater weighing and a digital scale were used to assess body composition, and fasting blood samples were collected to assess metabolic hormones.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sedentary Control | Experimental | Other: Sedentary ControlParticipants did not exercise but consumed a diet that has an appropriate number of calories to maintain body weight throughout the intervention (3 menstrual cycles). |
| Exercising control | Experimental | Other: Exercising controlParticipants exercised but were given extra calories to remain in energy balance throughout the intervention (3 menstrual cycles). |
| 15 percent energy deficit (ED1) | Experimental | Other: 15 percent energy deficitParticipants exercised for the equivalent of 15 percent of their daily caloric intake needs throughout the intervention cycles. |
| 30 percent energy deficit (ED2) | Experimental | Other: 30 percent energy deficitParticipants exercised for the equivalent of 30 percent of their daily caloric intake needs throughout the intervention cycles. |
| 30 percent energy deficit 15/15 (ED2) | Experimental | Other: 30 percent energy deficit (15/15)Participants exercised for the equivalent of 15 percent of their daily caloric intake needs throughout the intervention cycles, and their dietary intake was decreased by 15 percent to total a 30 percent energy deficit. |
| 60 percent energy deficit (ED3) | Experimental | Other: 60 percent energy deficitParticipants exercised for the equivalent of 30 percent of their daily caloric intake needs throughout the intervention cycles, and their dietary intake was decreased by 30 percent to total a 60 percent energy deficit. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Weight 45-75 kg
- Body fat 15-35 percent
- BMI 18-25 kg/m2
- Nonsmoking
- <1 hour/week of purposeful aerobic exercise for the past 6 months
Key exclusion criteria (5 listed)
- History of serious medical conditions
- Medication use that would alter metabolic hormone levels
- Significant weight loss/gain (±2.3 kg) in the last year
- Current evidence of disordered eating or history of an eating disorder
- Taking exogenous hormonal contraceptives for the past 6 months
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 |
|---|---|---|
| Sedentary ControlAlso: DietDiet: Participants consumed meals in the General Clinical Research Center metabolic kitchen that had calories sufficient to maintain body weight. Diet composition was 55 percent carbohydrates, 30 percent fat, and 15 percent protein. | Other | Sedentary Control |
| Exercising controlAlso: DietExercise: Participants engaged in supervised exercise training in Noll Laboratory Diet: Participants consumed meals in the General Clinical Research Center metabolic kitchen that had calories sufficient to maintain body weight and additional calories to remain in energy balance. Diet composition was 55 percent carbohydrates, 30 percent fat, and 15 percent protein. | Other | Exercising control |
| 15 percent energy deficitAlso: Diet and exerciseExercise: Participants engaged in supervised exercise training in Noll Laboratory that was equal to 15 percent of the participants' daily caloric needs. Diet: Participants consumed meals in the General Clinical Research Center metabolic kitchen that had calories to meet metabolic needs (before 15 percent deficit exercise). Diet composition was 55 percent carbohydrates, 30 percent fat, and 15 percent protein. | Other | 15 percent energy deficit (ED1) |
| 30 percent energy deficitAlso: Diet and exerciseExercise: Participants engaged in supervised exercise training in Noll Laboratory that was equal to 30 percent of the participants' daily caloric needs. Diet: Participants consumed meals in the General Clinical Research Center metabolic kitchen that had calories to meet metabolic needs (before 30 percent deficit exercise). Diet composition was 55 percent carbohydrates, 30 percent fat, and 15 percent protein. | Other | 30 percent energy deficit (ED2) |
| 30 percent energy deficit (15/15)Also: Diet and exerciseExercise: Participants engaged in supervised exercise training in Noll Laboratory that was equal to 15 percent of the participants' daily caloric needs. Diet: Participants consumed meals in the General Clinical Research Center metabolic kitchen that had 15 percent less calories than those needed to meet metabolic needs. Diet composition was 55 percent carbohydrates, 30 percent fat, and 15 percent protein. | Other | 30 percent energy deficit 15/15 (ED2) |
| 60 percent energy deficitAlso: Diet and exerciseExercise: Participants engaged in supervised exercise training in Noll Laboratory that was equal to 30 percent of the participants' daily caloric needs. Diet: Participants consumed meals in the General Clinical Research Center metabolic kitchen that had 30 percent less calories than those needed to meet metabolic needs. Diet composition was 55 percent carbohydrates, 30 percent fat, and 15 percent protein. | Other | 60 percent energy deficit (ED3) |
Primary outcome
Change in frequency of menstrual disturbances (disturbances /cycle)
Time frame: Baseline Menstrual Cycle (MC) (28 days (d) or the length of 1 MC, intervention MC 1 (28 days or the length of 1 MC), intervention MC 2 (28 days or the length of 1 MC), and intervention MC 3 (28 days or the length of 1 MC)
Frequency of menstrual disturbances including luteal phase defects, anovulation, oligomenorrhea cycles, and anovulatory cycles analyzed by daily urinary metabolites of estrone-1-glucuronide (E1G), pregnanediol glucuronide (PdG), and midcycle LH
9 secondary outcomes
Change in percent body fat
Time frame: Baseline Menstrual Cycle (MC) (28 days (d) or the length of 1 MC, intervention MC 1 (28 days or the length of 1 MC), intervention MC 2 (28 days or the length of 1 MC), and intervention MC 3 (28 days or the length of 1 MC), & Post Study (days 1-7)
Change in metabolic hormones
Time frame: Baseline Menstrual Cycle (MC) (28 days (d) or the length of 1 MC, Mid- study (week 3 of MC during intervention MC 2) an (28 days (d) or the length of 1 MC), & Post Study (Days (d)1-7 of cycle
Change in cycle length (days (d))
Time frame: Baseline Menstrual Cycle (MC) (28 days (d) or the length of 1 MC, intervention MC 1 (28 days or the length of 1 MC), intervention MC 2 (28 days or the length of 1 MC), and intervention MC 3 (28 days or the length of 1 MC)
Change in aerobic capacity
Time frame: Baseline Menstrual Cycle (MC) (28 days (d) or the length of 1 MC, & Post Study (Days (d)1-7 of cycle
Change in body weight
Time frame: Baseline Menstrual Cycle (MC) (28 days (d) or the length of 1 MC, intervention MC 1 (28 days or the length of 1 MC), intervention MC 2 (28 days or the length of 1 MC), and intervention MC 3 (28 days or the length of 1 MC), & Post Study (days 1-7)
Change in fat mass
Time frame: Baseline Menstrual Cycle (MC) (28 days (d) or the length of 1 MC, intervention MC 1 (28 days or the length of 1 MC), intervention MC 2 (28 days or the length of 1 MC), and intervention MC 3 (28 days or the length of 1 MC), & Post Study (days 1-7)
Change in fat free mass
Time frame: Baseline Menstrual Cycle (MC) (28 days (d) or the length of 1 MC, intervention MC 1 (28 days or the length of 1 MC), intervention MC 2 (28 days or the length of 1 MC), and intervention MC 3 (28 days or the length of 1 MC), & Post Study (days 1-7)
Change in follicular phase length
Time frame: Baseline Menstrual Cycle (MC) (28 days (d) or the length of 1 MC, intervention MC 1 (28 days or the length of 1 MC), intervention MC 2 (28 days or the length of 1 MC), and intervention MC 3 (28 days or the length of 1 MC)
Change in luteal phase length
Time frame: Baseline Menstrual Cycle (MC) (28 days (d) or the length of 1 MC, intervention MC 1 (28 days or the length of 1 MC), intervention MC 2 (28 days or the length of 1 MC), and intervention MC 3 (28 days or the length of 1 MC)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2021.
- Results publication: PubMed 29023359Lieberman JL, DE Souza MJ, Wagstaff DA, Williams NI. Menstrual Disruption with Exercise Is Not Linked to an Energy Availability Threshold. Med Sci Sports Exerc. 2018 Mar;50(3):551-561. doi: 10.1249/MSS.0000000000001451.
- Results publication: PubMed 25352438Williams NI, Leidy HJ, Hill BR, Lieberman JL, Legro RS, De Souza MJ. Magnitude of daily energy deficit predicts frequency but not severity of menstrual disturbances associated with exercise and caloric restriction. Am J Physiol Endocrinol Metab. 2015 Jan 1;308(1):E29-39. doi: 10.1152/ajpendo.00386.2013. Epub 2014 Oct 28.
- Individual participant dataSharing planned: No
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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.
Nancy I Williams, ScD principal investigator
Penn State University
Questions about this trial
What is this clinical trial studying?
A study testing 15 percent energy deficit, 30 percent energy deficit and 30 percent energy deficit (15/15) in people with Menstruation Disturbances and Luteal Phase Defect, run by Penn State University.
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 6 inclusion and 5 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: finished, as of the sponsor's last update on 24 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in frequency of menstrual disturbances (disturbances /cycle) (time frame: Baseline Menstrual Cycle (MC) (28 days (d) or the length of 1 MC, intervention MC 1 (28 days or the length of 1 MC), intervention MC 2 (28 days or the length of 1 MC), and intervention MC 3 (28 days or the length of 1 MC)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04938622, which also lists 2 linked publications.
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 24 Jun 2021.