No phaseCompleted

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

Sponsor
National Institute of Environmental Health Sciences (NIEHS) (NIH)
Enrolment
38 enrolled
Conditions
Hormones
Interventions
NEA; DEA
Ages
adults
Registry
NCT02858336

From the registry

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…

Primary outcomes

  • The primary outcome measure will be change in daytime LH pulse frequency following 5 days of neutral energy availability as compared to LH pulse frequency following 5 days deficient energy availability. LH pulse frequency.
Full record on ClinicalTrials.gov