Low Energy Availability and Pituitary Function (LEAP Study)

Sponsor

University of Colorado, Denver (Other)

Overall Status

Recruiting

CT.gov ID

NCT05808647

Collaborator

(none)

Enrollment

Location

Arms

21.1

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hypogonadotropic Hypogonadism	Behavioral: 5-day controlled metabolic dietary intake	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2024

Anticipated Study Completion Date :

Jan 1, 2025

Arms and Interventions

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.

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.

Outcome Measures

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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado Anschutz Medical Campus	Aurora	Colorado	United States	80045

Sponsors and Collaborators

University of Colorado, Denver

Investigators

Principal Investigator: Ann E Caldwell, PhD, University of Colorado Anschutz School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Colorado, Denver

ClinicalTrials.gov Identifier:

NCT05808647

Other Study ID Numbers:

22-1811

First Posted:

Apr 11, 2023

Last Update Posted:

Apr 11, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypogonadism

Study Results

No Results Posted as of Apr 11, 2023