Controlled Diet for Reproductive Hormone Levels
(LEAP Trial)
TC
Overseen ByTrish Coordinator, MS, RD
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: University of Colorado, Denver
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
AE
Ann E Caldwell, PhD
Principal Investigator
University of Colorado Anschutz School of Medicine
Are You a Good Fit for This Trial?
This trial is for women aged 18-30 with a BMI of 18.5-24.9 or 30-45, who have had regular menstrual cycles and stable weight recently. It's not for those on hormonal birth control, pregnant, planning pregnancy soon, diagnosed with PCOS, exercising regularly, or with significant health issues like heart disease or diabetes.Inclusion Criteria
You have not gained or lost more than 5 kilograms in the past 3 months.
My BMI is either between 18.5-24.9 or 30-45.
You have had regular periods every 18 to 40 days for the past 6 months.
See 1 more
Exclusion Criteria
I have serious health issues like heart disease or diabetes.
I have been diagnosed with polycystic ovary syndrome.
Doing regular planned aerobic workouts.
See 2 more
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants follow a 5-day individualized, standardized diet at two levels: energy balance and low energy intake
5 days
2 visits (in-person)
Follow-up
Participants are monitored for changes in reproductive hormones and pituitary function
8 weeks
3 visits (in-person)
What Are the Treatments Tested in This Trial?
Interventions
- Individualized, Standardized Diet
Trial Overview The LEAP Study is examining how reproductive hormones in young women respond to eating a controlled diet that's either balanced in energy or has low energy intake over five days.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Low energy availability metabolic diet (5-days)Experimental Treatment1 Intervention
Group II: Energy balanced metabolic diet (5-days)Active Control1 Intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor
Trials
1,842
Recruited
3,028,000+
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