CaREFREE Study (Calorie Restriction, Environment and Fitness: Reproductive Effects Evaluation Study) (NCT02858336) | Clinical Trial Compass
CompletedNot Applicable
CaREFREE Study (Calorie Restriction, Environment and Fitness: Reproductive Effects Evaluation Study)
United States38 participantsStarted 2017-01-12
Plain-language 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.
Who can participate
Age range
18 Years – 28 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Female
. Between 18 and 28 years of age (inclusive)
. Reported menarche between the ages of 11 and 14 years
. Gynecological age of \<= 14 years
. A history of self-reported regular menstrual cycles when not on contraceptive medication of between 25 and 35 days (inclusive) at prescreen and knowledge of date of onset of menses before the screening visit
. A BMI of 18.5 to 27 kg x m\^2 and a weight \>= 93 lbs.
. Agrees to use barrier contraception method for the duration of the study and the follow up period
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
Timeframe: NEA Intervention Day 5 and DEA Intervention Day 5
Trial details
NCT IDNCT02858336
SponsorNational Institute of Environmental Health Sciences (NIEHS)
. Agrees to abstain from alcohol consumption during both 5-day diet/exercise study interventions
Exclusion criteria
. Currently lactating or pregnant or planning on becoming pregnant for the duration of the study
. Has ever given birth
. History in the past 3 months of dieting or weight loss amounting to greater than 2 kg
. \> 4 hours per week of aerobic exercise for the past 3 months
. Has initiated training for an athletic sport or event in the past 3 months that, in the opinion of the investigator, may interfere with the results of the study
. Currently using hormone-based contraception, including those administered orally, vaginally, via injection, sub-dermally, or transdermally
. Current use of medications or supplements that may interfere with the results of the study, including:
. Current use of recreational drugs (alcohol intake will be monitored and excluded during the two intervention periods)