Low Energy Availability and Pituitary Function (LEAP Study) (LEAP)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypogonadotropic Hypogonadism
• Intervention / Treatment: Behavioral: 5-day controlled metabolic dietary intake

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Trish Coordinator, MS, RD; Phone Number: 303-724-6821; Email: HoWL@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Anschutz Medical Campus
      • Contact: Trish Coordinator, MS, RD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Energy balanced metabolic diet (5-days); 45 kcals/kg of fat free mass [FFM]/day; 28% fat, 15% protein, 57% carbohydrate	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.
Experimental: Low energy availability metabolic diet (5-days); 20 kcal/kg of FFM/day; 28% fat, 15% protein, 57% carbohydrate	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Ann E Caldwell, PhD, University of Colorado Anschutz School of Medicine

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2023
• Primary Completion (Anticipated): November 1, 2024
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: March 29, 2023
• First Submitted That Met QC Criteria: April 10, 2023
• First Posted (Actual): April 11, 2023

Study Record Updates

• Last Update Posted (Actual): April 11, 2023
• Last Update Submitted That Met QC Criteria: April 10, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Gonadal Disorders; Hypogonadism
• Other Study ID Numbers: 22-1811

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Beginning 3 months after publication. No end date.
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No