Controlled Diet for Reproductive Hormone Levels
(LEAP Trial)

Recruiting in Palo Alto (17 mi)

Overseen byAnn E Caldwell, PhD

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Colorado, Denver

No Placebo Group

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.

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.

+2 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.

+2 more

Participant Groups

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.

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