RECRUITING

Low Energy Availability and Pituitary Function (LEAP Study)

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 purpose of this study is to learn more about reproductive hormones and if they change in response to 5-days eating an individualized, standardized diet at two levels: energy balance and low energy intake.

Official Title

A Randomized Cross-over Study of Low Energy Availability on Pituitary Function in Women

Quick Facts

Study Start:2023-04
Study Completion:2025-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05808647

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 30 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female
  2. * Age 18-30
  3. * Body mass index between 18.5-24.9 OR 30-45
  4. * Have regular menstrual cycles between 18-40 days over the past 6 months
  5. * Weight stable (not gained or lost 5kg) in the past 3 months
  1. * Using hormonal birth control currently or within the past three months
  2. * Polycystic ovary syndrome (current or past diagnosis)
  3. * Pregnant, lactating, planning to become pregnant in next 6 months
  4. * Engaging in regular intentional aerobic exercise
  5. * Significant medical issues (e.g.,cardiovascular disease or diabetes)

Contacts and Locations

Study Contact

Trish Coordinator, MS, RD
CONTACT
303-724-6821
HoWL@cuanschutz.edu

Principal Investigator

Ann E Caldwell, PhD
PRINCIPAL_INVESTIGATOR
University of Colorado Anschutz School of Medicine

Study Locations (Sites)

University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

  • Ann E Caldwell, PhD, PRINCIPAL_INVESTIGATOR, University of Colorado Anschutz School of Medicine

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 Date2023-04
Study Completion Date2025-01

Study Record Updates

Study Start Date2023-04
Study Completion Date2025-01

Terms related to this study

Additional Relevant MeSH Terms

  • Hypogonadotropic Hypogonadism