Low Energy Availability and Pituitary Function (LEAP Study)
NCT ID: NCT05808647
Last Updated: 2023-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
25 participants
INTERVENTIONAL
2023-04-30
2025-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Energy Balance Weight Regulation Study
NCT00619008
The Effects of Energy Imbalance on Food Intake Behaviors
NCT03112161
Brown Adipose Tissue Activity in Pre- and Postmenopausal Women
NCT02927392
Time-restricted Eating in Peri- and Postmenopausal Women
NCT06188598
Effect of Feeding Status on Appetite and Eating Behaviour.
NCT07257692
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
OTHER
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Energy balanced metabolic diet (5-days)
45 kcals/kg of fat free mass \[FFM\]/day; 28% fat, 15% protein, 57% carbohydrate
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.
Low energy availability metabolic diet (5-days)
20 kcal/kg of FFM/day; 28% fat, 15% protein, 57% carbohydrate
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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)
18 Years
30 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Colorado, Denver
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ann E Caldwell, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado Anschutz School of Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Trish Coordinator, MS, RD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
22-1811
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.