Low Energy Availability and Pituitary Function (LEAP Study)

University of Colorado, Denver25 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Hypogonadotropic Hypogonadism

Interventions

5-day controlled metabolic dietary intakeBEHAVIORAL

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 30 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: Baseline, ~4-weeks, ~8-weeks (visits timed to to days 1-5 of the menstrual cycle)

Central Contacts

Trish Coordinator, MS, RD

CONTACT

303-724-6821 HoWL@cuanschutz.edu

Data from ClinicalTrials.gov

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