Low Energy Availability and Pituitary Function (LEAP Study)

Hypogonadotropic Hypogonadism Clinical Trial

— LEAP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05808647
• Other study ID #: 22-1811
• Status: Recruiting
• Phase: N/A
• Start date: April 2023
• Est. completion date: January 2025

Study information

• Verified date: April 2023
• Source: University of Colorado, Denver
• Contact: Trish Coordinator, MS, RD
• Phone: 303-724-6821
• Email: HoWL[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: January 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• Female
• Age 18-30
• Body mass index between 18.5-24.9 OR 30-45
• Have regular menstrual cycles between 18-40 days over the past 6 months
• Weight stable (not gained or lost 5kg) in the past 3 months

Exclusion Criteria:

• Using hormonal birth control currently or within the past three months
• Polycystic ovary syndrome (current or past diagnosis)
• Pregnant, lactating, planning to become pregnant in next 6 months
• Engaging in regular intentional aerobic exercise
• Significant medical issues (e.g.,cardiovascular disease or diabetes)

Related Conditions & MeSH terms

• Hypogonadism
• Hypogonadotropic Hypogonadism

Intervention

Behavioral:
• 5-day controlled metabolic dietary intake
Over 5-days, all food will be provided from the metabolic kitchen and participants will be instructed to eat all of the food provided each day and only the food provided each day.

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in stimulated pituitary function, as measured by Luteinizing hormone (LH) area under the curve (AUC) over two hours following pituitary stimulation with a physiologic bolus intravenous dose of gonadorelin acetate	Within-participant changes in response to both conditions will be measured, with lower LH AUC indicating a blunted pituitary response to stimulation.	Baseline, ~4-weeks, ~8-weeks (visits timed to to days 1-5 of the menstrual cycle)