Low Energy Availability and Pituitary Function (LEAP Study)

NCT05808647 | Unknown

• 1 other identifier: 22-1811
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypogonadotropic Hypogonadism

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

Energy balanced metabolic diet (5-days)

ACTIVE COMPARATOR

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

Behavioral: 5-day controlled metabolic dietary intake

Low energy availability metabolic diet (5-days)

EXPERIMENTAL

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

Behavioral: 5-day controlled metabolic dietary intake

Interventions

5-day controlled metabolic dietary intake BEHAVIORAL

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.

Energy balanced metabolic diet (5-days); Low energy availability metabolic diet (5-days)

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Hypogonadism

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Study Officials

• Ann E Caldwell, PhD

  University of Colorado Anschutz School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Trish Coordinator, MS, RD

CONTACT

303-724-6821; HoWL@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: April 11, 2023
• Study Start: April 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: January 1, 2025
• Last Updated: April 11, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning 3 months after publication. No end date.
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

US (1)