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Controlled Diet for Reproductive Hormone Levels (LEAP Trial)

N/A

Recruiting

Led By Ann E Caldwell, PhD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18-30

Be between 18 and 65 years old

Must not have

Significant medical issues (e.g., cardiovascular disease or diabetes)

Polycystic ovary syndrome (current or past diagnosis)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, ~4-weeks, ~8-weeks (visits timed to to days 1-5 of the menstrual cycle)

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how diet affects reproductive hormone levels, with 2 different levels of energy intake.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the intervention involves dietary changes only and does not include medication or invasive procedures, side effects are expected to be minimal but may include feelings of hunger or fatigue due to low energy intake.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 30 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have serious health issues like heart disease or diabetes.

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I have been diagnosed with polycystic ovary syndrome.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, ~4-weeks, ~8-weeks (visits timed to to days 1-5 of the menstrual cycle)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, ~4-weeks, ~8-weeks (visits timed to to days 1-5 of the menstrual cycle)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, ~4-weeks, ~8-weeks (visits timed to to days 1-5 of the menstrual cycle) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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