Controlled Diet for Reproductive Hormone Levels

(LEAP Trial)

Overseen By Trish Coordinator, MS, RD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Must not be taking: Hormonal birth control

Disqualifiers: Polycystic ovary syndrome, pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

25 Participants Needed

Trial Summary

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.

Research Team

Ann E Caldwell, PhD

Principal Investigator

University of Colorado Anschutz School of Medicine

Eligibility Criteria

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.

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.

Treatment Details

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.

Participant Groups

Group I: Low energy availability metabolic diet (5-days) Experimental Treatment 1 Intervention

20 kcal/kg of FFM/day; 28% fat, 15% protein, 57% carbohydrate

Group II: Energy balanced metabolic diet (5-days) Active Control 1 Intervention

45 kcals/kg of fat free mass \[FFM\]/day; 28% fat, 15% protein, 57% carbohydrate

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+