Bioenergetics of Exercise-Induced Menstrual Disturbances

NCT04938622 | Completed

• 2 other identifiers: 990878R01HD039245-01
• Study Type: interventional
• Target: 47
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Menstruation Disturbances; Luteal Phase Defect; Amenorrhea; Oligomenorrhea

Keywords

Energy Balance; Menstrual Cycle Disturbance; Luteal Phase Defect; Amenorrhea; Oligomenorrhea

Outcome Measures

Primary Outcomes (1)

• 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

  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

  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

  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))

  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

  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

  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)

Study Arms (6)

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).

Other: Sedentary Control

Exercising control

EXPERIMENTAL

Participants exercised but were given extra calories to remain in energy balance throughout the intervention (3 menstrual cycles).

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.

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.

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.

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.

Other: 60 percent energy deficit

Interventions

Sedentary Control OTHER

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.

Also known as: Diet

Sedentary Control

Exercising control OTHER

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.

Also known as: Diet

Exercising control

15 percent energy deficit OTHER

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.

Also known as: Diet and exercise

15 percent energy deficit (ED1)

30 percent energy deficit OTHER

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.

Also known as: Diet and exercise

30 percent energy deficit (ED2)

30 percent energy deficit (15/15) OTHER

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.

Also known as: Diet and exercise

30 percent energy deficit 15/15 (ED2)

60 percent energy deficit OTHER

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.

Also known as: Diet and exercise

60 percent energy deficit (ED3)

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Penn State University: lead
• National Institutes of Health (NIH): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Related Publications (2)

• 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.

  PMID: 29023359 RESULT

• Williams 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.

  PMID: 25352438 RESULT

MeSH Terms

Conditions

Menstruation Disturbances; Amenorrhea; Oligomenorrhea

Interventions

Diet; Exercise

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Nancy I Williams, ScD

  Penn State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Head, Department of Kinesiology

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 24, 2021
• Study Start: May 1, 2001
• Primary Completion: April 30, 2005
• Study Completion: April 30, 2005
• Last Updated: June 24, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share