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CaREFREE Study (Calorie Restriction, Environment and Fitness: Reproductive Effects Evaluation Study)

NCT02858336 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2026-05-22

No results posted yet for this study

Summary

Background:

Functional hypothalamic amenorrhea (functional HA) is a condition where a woman s period stops for a temporary time. This is due to improper function of the hypothalamus. This is the part of the brain that directs the whole reproductive system. Researchers want to learn more about functional HA. They also want to learn how diet, exercise, and other factors may change women s menstrual cycles.

Objective:

To better understand functional HA.

Eligibility:

Healthy women ages 18-28 years old who:

* Have regular periods
* Exercise no more than 4 hours a week
* Had their first period at age 11-14

Design:

Participants will be prescreened over the phone.

Participants will be screened with:

* Blood and urine tests
* Medical history
* Physical exam.

Participants will have 9 or 10 visits over about 3 menstrual cycles. These include:

* Repeat of screening tests
* Questionnaires
* Exercise test
* Resting energy expenditure test: Participants fast overnight before the test. They lie on their back under a canopy for a half hour.
* Body composition test: This is done with a dual energy x-ray absorptiometry (DXA) scan.
* Pelvic ultrasound
* For two full-day visits, an IV is inserted into an arm vein. The IV takes a blood sample every 10 minutes for 8 hours.

Participants will keep logs:

* Menstrual cycle log
* Diet log for three 4-day cycles

Participants will receive test kits to complete at home:

* Daily blood and urine sample
* Ovulation

Participants will take a daily iron supplement. They will wear a wristband that monitors activity 24 hours a day.

Participants will stick to a special diet for two 5-day periods of time. They will complete two 4-day exercise programs....

Conditions

  • Hormones

Interventions

BEHAVIORAL

NEA

Neutral Energy Availability: 5-day outpatient intervention of prescribed diet and exercise to elicit an energy availability of 45 kcal/kg LBM day.

BEHAVIORAL

DEA

Deficient Energy Availability: 5-day outpatient intervention of prescribed diet and exercise to elicit an energy availability of 20 kcal/kg LBM day.

Sponsors & Collaborators

  • National Institute of Environmental Health Sciences (NIEHS)

    lead NIH

Principal Investigators

  • Natalie D Shaw, M.D. · National Institute of Environmental Health Sciences (NIEHS)

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
28 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-12
Primary Completion
2019-06-29
Completion
2019-06-29

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02858336 on ClinicalTrials.gov