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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
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
LEAP Trial 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.Check my eligibility
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.See study design
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.
LEAP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 30 years old.
LEAP Trial 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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.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
LEAP Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Low energy availability metabolic diet (5-days)Experimental Treatment1 Intervention
20 kcal/kg of FFM/day; 28% fat, 15% protein, 57% carbohydrate
Group II: Energy balanced metabolic diet (5-days)Active Control1 Intervention
45 kcals/kg of fat free mass [FFM]/day; 28% fat, 15% protein, 57% carbohydrate
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Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,752 Previous Clinical Trials
2,165,574 Total Patients Enrolled
Ann E Caldwell, PhDPrincipal InvestigatorUniversity of Colorado Anschutz School of Medicine
1 Previous Clinical Trials
21 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility 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.I have serious health issues like heart disease or diabetes.You have had regular periods every 18 to 40 days for the past 6 months.I have been diagnosed with polycystic ovary syndrome.I am between 18 and 30 years old.Doing regular planned aerobic workouts.I am female.
Research Study Groups:
This trial has the following groups:- Group 1: Energy balanced metabolic diet (5-days)
- Group 2: Low energy availability metabolic diet (5-days)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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