Skip to content

Low Energy Availability and Pituitary Function (LEAP Study)

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05808647
Acronym
LEAP
Enrollment
25
Registered
2023-04-11
Start date
2023-04-30
Completion date
2025-01-31
Last updated
2023-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypogonadotropic Hypogonadism

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.

Interventions

BEHAVIORAL5-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.

Sponsors

University of Colorado, Denver
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 30 Years
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)

Design outcomes

Primary

MeasureTime frameDescription
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 acetateBaseline, ~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.

Countries

United States

Contacts

Primary ContactTrish Coordinator, MS, RD
HoWL@cuanschutz.edu303-724-6821

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026