RECRUITING

Timing of Energy Availability on Menstrual Cycle Function

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary aim of this clinical trial is to evaluate how fasted prolonged exercise may influence circulating reproductive hormones (i.e., estradiol, progesterone, luteinizing hormone) and menstrual cycle length when energy availability is maintained at or above 30 kcal/kg lean body mass/ day among women who regularly do running or cycling exercise. A secondary aim is to determine the effects of fasted prolonged exercise on serum leptin and cortisol. Participants will be asked to do the following over a \~3 month enrollment period: * attend a laboratory visit at the beginning of the study to have their resting metabolic rate, aerobic fitness, and body composition tested * monitor their menstrual cycle length, urine hormones, perceived stress levels, and diet for \~3 months * complete 3, 90-minute exercise sessions on a stationary bike or treadmill either fed (consuming a carbohydrate meal 1 h prior and 0.7 g carbohydrate/ kg body mass/ h during exercise) or fasted (consuming no meal prior and no carbohydrates during exercise) during month \~3 * saliva samples will be taken prior to and after 90-minute exercise sessions for quantification of leptin and cortisol

Official Title

Implications for the Timing of Energy Availability on Menstrual Cycle Function

Quick Facts

Study Start:2024-08-01
Study Completion:2027-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06471582

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 40 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * participates in structured running or cycling exercise for at least 30 minutes on 3 or more days per week
  2. * accustomed to exercising for 90 minutes or more
  3. * has regular periods every 21-35 days
  4. * have not taken hormonal contraceptives for at least the past 6 months
  5. * is not currently or trying to become pregnant or breastfeeding, and has not been pregnant or breastfeeding in the past 12 months
  6. * does not currently have a diagnosis of a major menstrual cycle disorder (i.e., amenorrhea, polycystic ovary syndrome \[PCOS\], endometriosis, ovarian cancer, ovarian insufficiency, uterine or endometrial cancer)
  7. * does not currently have a metabolic disease (i.e., hypothyroidism, hyperthyroidism, Cushing disease, Addison's disease, diabetes, congenital adrenal hyperplasia)
  8. * does not currently have a major cardiovascular or respiratory disease
  1. * miss more than 7 consecutive days of aerobic activity (i.e., running, cycling, cross training)
  2. * demonstrate clinical low energy availability as defined as energy availability \<30 kcal/kg fat free mass
  3. * report menstrual cycle lengths \<21 or \>35 days in the first 2 months of at-home monitoring
  4. * do not demonstrate an anticipated rise in luteinizing hormone and progesterone in the first 2 months of at-home monitoring
  5. * begin taking a hormonal contraceptive
  6. * become pregnant
  7. * are diagnosed with a menstrual cycle disorder (i.e., amenorrhea, polycystic ovary syndrome \[PCOS\], endometriosis, ovarian cancer, ovarian insufficiency, uterine, or endometrial cancer)
  8. * are diagnosed with a metabolic disease (i.e., hypothyroidism, hyperthyroidism, Cushing disease, Addison's disease, diabetes)
  9. * are diagnosed with a major cardiovascular or respiratory disease
  10. * are unable to follow instructions for any of the procedures

Contacts and Locations

Study Contact

Marissa Baranauskas, PhD
CONTACT
719-255-4475
mbaranau@uccs.edu

Study Locations (Sites)

William J. Hybl Sports Medicine and Performance Center
Colorado Springs, Colorado, 80918
United States

Collaborators and Investigators

Sponsor: University of Colorado, Colorado Springs

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-01
Study Completion Date2027-08-31

Study Record Updates

Study Start Date2024-08-01
Study Completion Date2027-08-31

Terms related to this study

Keywords Provided by Researchers

  • functional hypothalamic amenorrhea
  • menstrual cycle
  • female athlete

Additional Relevant MeSH Terms

  • Menstrual Irregularity