Clinical Trials Logo

Clinical 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. 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT04938622
Study type Interventional
Source Penn State University
Contact
Status Completed
Phase N/A
Start date May 1, 2001
Completion date April 30, 2005

See also
  Status Clinical Trial Phase
Completed NCT01927432 - Ultrasound Characterization of Ovarian Follicle Dynamics in Women With Amenorrhea
Completed NCT00196391 - A Trial to Evaluate DR-2021 in Women With Secondary Amenorrhea Phase 2
Completed NCT00152282 - A Study to Evaluate the Safety and Effectiveness of Asoprisnil and Estrogen Administration to Postmenopausal Women Phase 2
Recruiting NCT00456274 - Baselines in Reproductive Disorders N/A
Terminated NCT00556400 - Treatment of Menorrhagia in Women With Thrombocytopenia Using Platelets or Platelets and Hormones Phase 1/Phase 2
Completed NCT00429494 - GnRH Analogue for Ovarian Function Preservation in Hematopoietic Stem Cell Transplantation Patients Phase 2
Completed NCT04135729 - Mental Health in Fitness Instructors
Recruiting NCT03916978 - Autologous PRP Intra Ovarian Infusion to Restore Ovarian Function in Menopausal Women Phase 2/Phase 3
Completed NCT00243607 - Hydrotherapy Against Menopausal Symptoms in Breast Cancer Survivors N/A
Completed NCT00001275 - Ovarian Follicle Function in Patients With Primary Ovarian Failure N/A
Recruiting NCT06280807 - Observation of Environment and Reproductive-Endocrine Effects
Not yet recruiting NCT02393482 - Psychological Impact of Amenorrhea in Women With Endometriosis Phase 4
Completed NCT01206153 - Metformin for Treatment Antipsychotic Induced Amenorrhea in Female Schizophrenic Patients Phase 4
Recruiting NCT04424576 - Ovarian Morphology in Girls
Completed NCT02224976 - Effect of Intense Training on Ovarian Function and Bone Turnover N/A
Active, not recruiting NCT01785719 - Evaluation of Ovarian Morphology and Function in Overweight Women During Weight Loss N/A
Recruiting NCT00383656 - Pulsatile GnRH in Anovulatory Infertility Phase 2
Terminated NCT00881608 - Study to Evaluate Menses Induction in Women Administered Proellex Phase 1
Active, not recruiting NCT01103518 - Ethinyl Estradiol and Cyproterone Acetate in Irregular Menstruation Phase 4
Withdrawn NCT00827151 - Bone Mass Accrual in Adolescent Athletes Phase 3