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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 below
Select...
I am between 18 and 30 years old.

LEAP Trial Timeline

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

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

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,738 Previous Clinical Trials
2,149,501 Total Patients Enrolled
Ann E Caldwell, PhDPrincipal InvestigatorUniversity of Colorado Anschutz School of Medicine
1 Previous Clinical Trials
21 Total Patients Enrolled

Media Library

Low energy availability metabolic diet (5-days) Clinical Trial Eligibility Overview. Trial Name: NCT05808647 — N/A
Hypogonadotropic Hypogonadism Research Study Groups: Energy balanced metabolic diet (5-days), Low energy availability metabolic diet (5-days)
Hypogonadotropic Hypogonadism Clinical Trial 2023: Low energy availability metabolic diet (5-days) Highlights & Side Effects. Trial Name: NCT05808647 — N/A
Low energy availability metabolic diet (5-days) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05808647 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age limit for this research project restricted to those under 30?

"This medical trial is welcoming participants between the ages of 18 and 30."

Answered by AI

Are there still available openings for the trial's participants?

"Confirmed. Clinicaltrials.gov indicates that enrolment for this trial is still open, with the initial posting date being April 1st 2023 and the last update occurring on April 10th of the same year."

Answered by AI

How many participants are enrolled in this clinical investigation?

"Affirmative. According to clinicaltrials.gov, prospective participants are currently being sought for this research initiative which was first advertised on April 1st 2023 and last modified on the 10th of that same month. 25 individuals need to be sourced from a single medical centre."

Answered by AI

Who are the eligible participants for this experiment?

"Meeting the criteria of hypogonadotropic hypogonadism and aged between 18 to 30 is required for eligibility in this clinical trial. There are 25 vacancies open at present."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Low Energy Availability and Pituitary Function (LEAP Study)
2023. "Low Energy Availability and Pituitary Function (LEAP Study)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05808647.
All > Growth Hormone Deficiency
~8 spots leftby Nov 2024
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