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

Primary Purpose

Hypogonadotropic Hypogonadism

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
5-day controlled metabolic dietary intake
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hypogonadotropic Hypogonadism

Eligibility Criteria

18 Years - 30 Years (Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • University of Colorado Anschutz Medical CampusRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Energy balanced metabolic diet (5-days)

Low energy availability metabolic diet (5-days)

Arm Description

45 kcals/kg of fat free mass [FFM]/day; 28% fat, 15% protein, 57% carbohydrate

20 kcal/kg of FFM/day; 28% fat, 15% protein, 57% carbohydrate

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 29, 2023
Last Updated
April 10, 2023
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT05808647
Brief Title
Low Energy Availability and Pituitary Function (LEAP Study)
Acronym
LEAP
Official Title
A Randomized Cross-over Study of Low Energy Availability on Pituitary Function in Women
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 2023 (Anticipated)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadotropic Hypogonadism

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Energy balanced metabolic diet (5-days)
Arm Type
Active Comparator
Arm Description
45 kcals/kg of fat free mass [FFM]/day; 28% fat, 15% protein, 57% carbohydrate
Arm Title
Low energy availability metabolic diet (5-days)
Arm Type
Experimental
Arm Description
20 kcal/kg of FFM/day; 28% fat, 15% protein, 57% carbohydrate
Intervention Type
Behavioral
Intervention Name(s)
5-day controlled metabolic dietary intake
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
Within-participant changes in response to both conditions will be measured, with lower LH AUC indicating a blunted pituitary response to stimulation.
Time Frame
Baseline, ~4-weeks, ~8-weeks (visits timed to to days 1-5 of the menstrual cycle)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Trish Coordinator, MS, RD
Phone
303-724-6821
Email
HoWL@cuanschutz.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann E Caldwell, PhD
Organizational Affiliation
University of Colorado Anschutz School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Trish Coordinator, MS, RD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Low Energy Availability and Pituitary Function (LEAP Study)

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