Low Energy Availability and Pituitary Function (LEAP Study)

University of Colorado Denver (CU Denver)

Status: Enrolling

Conditions: Hypogonadotropic Hypogonadism

Treatments: Behavioral: 5-day controlled metabolic dietary intake

Study type: Interventional

Funder types: Other

Identifiers

NCT05808647

22-1811

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: Female

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Female
• Age 18-30
• Body mass index between 18.5-24.9 OR 30-45
• Have regular menstrual cycles between 18-40 days over the past 6 months
• Weight stable (not gained or lost 5kg) in the past 3 months

Exclusion criteria

• Using hormonal birth control currently or within the past three months
• Polycystic ovary syndrome (current or past diagnosis)
• Pregnant, lactating, planning to become pregnant in next 6 months
• Engaging in regular intentional aerobic exercise
• Significant medical issues (e.g.,cardiovascular disease or diabetes)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

25 participants in 2 patient groups

Energy balanced metabolic diet (5-days)

Active Comparator group

Description:

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

Treatment:

Behavioral: 5-day controlled metabolic dietary intake

Low energy availability metabolic diet (5-days)

Experimental group

Description:

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

Treatment:

Behavioral: 5-day controlled metabolic dietary intake