Low Energy Availability and Pituitary Function (LEAP Study)

Not Applicable

Recruiting

• Conditions: Hypogonadotropic Hypogonadism
• Interventions: Behavioral: 5-day controlled metabolic dietary intake

• Registration Number: NCT05808647
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-29
• Status Verified: 2023-04
• Study Start: 2023-04
• Study First Submitted QC: 2023-04-10
• Last Update Submitted: 2023-04-10
• Study First Posted: 2023-04-11
• Last Update Posted: 2023-04-11
• Primary Completion: 2024-11
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 25

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Energy balanced metabolic diet (5-days)	5-day controlled metabolic dietary intake	45 kcals/kg of fat free mass \[FFM\]/day; 28% fat, 15% protein, 57% carbohydrate
Low energy availability metabolic diet (5-days)	5-day controlled metabolic dietary intake	20 kcal/kg of FFM/day; 28% fat, 15% protein, 57% carbohydrate

Primary Outcome Measures

Name	Time	Method
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	Baseline, ~4-weeks, ~8-weeks (visits timed to to days 1-5 of the menstrual cycle)	Within-participant changes in response to both conditions will be measured, with lower LH AUC indicating a blunted pituitary response to stimulation.

Trial Locations

Locations (1)

University of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States