This study is NOT currently recruiting participants.
Number
16-E-0157
Sponsoring Institute
National Institute of Environmental Health Sciences (NIEHS)
Recruitment Detail
Type: Completed Study; data analyses ongoing Gender: Female Min Age: 18 Years Max Age: 28 Years
Referral Letter Required
No
Population Exclusion(s)
Non-English Speaking;Children;Male
Keywords
Luteinizing Hormone (LH); Weight Loss; Functional Hypothalamic Amenorrhea (HA); Gonadotropin-Releasing Hormone (GnRH); Energy Deficiency
Recruitment Keyword(s)
None
Condition(s)
Hormones
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Behavioral: NEA Behavioral: DEA
Supporting Site
National Institute of Environmental Health Sciences
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.
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INCLUSION CRITERIA: Participants will be enrolled without regard to race or ethnicity. Each potential participant must meet all of the following inclusion criteria in order to be eligible to enroll in the study: 1. Female 2. Between 18 and 28 years of age (inclusive) 3. Reported menarche between the ages of 11 and 14 years 4. Gynecological age of less than or equal to 14 years 5. 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 6. A BMI of 18.5 to 27 kg (Summation)m(2) and a weight >= 93 lbs. 7. Agrees to use barrier contraception method for the duration of the study and the follow up period 8. Agrees to abstain from alcohol consumption during both 5-day diet/exercise study interventions 9. Agrees to abstain from donating blood during the study and within 30 days of completing the study 10. Agrees to abstain from biotin supplements for the duration of the study 11. Is willing and able to fulfill the requirements of the protocol and to provide informed consent 12. Able to speak and read English 13. Lives within 50 miles of the Clinical Research Unit EXCLUSION CRITERIA: A potential participant meeting any of the following exclusion criteria is not eligible to enroll in the study: 1. Currently lactating or pregnant or planning on becoming pregnant for the duration of the study 2. Has ever given birth 3. History in the past 3 months of dieting or weight loss amounting to greater than 2 kg 4. > 4 hours per week of aerobic exercise for the past 3 months 5. 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 6. Currently using hormone-based contraception, including those administered orally, vaginally, via injection, sub-dermally, or transdermally 7. Current use of medications or supplements that may interfere with the results of the study, including: i.Steroids ii.Hormone-based contraception iii.Sleeping pills iv.Homeopathic substances (e.g. Chinese herbs, protein or other powders, and other-the-counter extracts) v.Stimulants (e.g. Ritalin) vi.Antidepressants or anti-epileptic medications or centrally acting anti-hypertensive medications 8. Current use of recreational drugs (alcohol intake will be monitored and excluded during the two intervention periods) 9. Unable to consume food containing dairy or nuts 10. Has currently or has a history of any of the following: autoimmune, heart, liver, renal disease, diabetes, or another health condition deemed by the PI to be a contraindication to study participation. History of thyroid disorder is permissible if the patient is biochemically euthyroid on replacement. Additional Eligibility Criteria to be Met Prior to Start of Intervention(s): Criteria 1 Habitual energy intake between 35-55 kcal/kg LBM*day Criteria 2 VO2max less than or equal to 40 ml/kg/min with the option to increase this at the discretion of the PI, depending on the current and past exercise level of the participant. Criteria 3 Hemoglobin, prolactin and TSH within normal female range for testing laboratory. Criteria 4 Ovulation confirmed in the cycle before each study intervention by self-reported positive urine test, ultrasound and/or progesterone blood-levels
Participants will be enrolled without regard to race or ethnicity. Each potential participant must meet all of the following inclusion criteria in order to be eligible to enroll in the study:
1. Female
2. Between 18 and 28 years of age (inclusive)
3. Reported menarche between the ages of 11 and 14 years
4. Gynecological age of less than or equal to 14 years
5. 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
6. A BMI of 18.5 to 27 kg (Summation)m(2) and a weight >= 93 lbs.
7. Agrees to use barrier contraception method for the duration of the study and the follow up period
8. Agrees to abstain from alcohol consumption during both 5-day diet/exercise study interventions
9. Agrees to abstain from donating blood during the study and within 30 days of completing the study
10. Agrees to abstain from biotin supplements for the duration of the study
11. Is willing and able to fulfill the requirements of the protocol and to provide informed consent
12. Able to speak and read English
13. Lives within 50 miles of the Clinical Research Unit
EXCLUSION CRITERIA:
A potential participant meeting any of the following exclusion criteria is not eligible to enroll in the study:
1. Currently lactating or pregnant or planning on becoming pregnant for the duration of the study
2. Has ever given birth
3. History in the past 3 months of dieting or weight loss amounting to greater than 2 kg
4. > 4 hours per week of aerobic exercise for the past 3 months
5. 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
6. Currently using hormone-based contraception, including those administered orally, vaginally, via injection, sub-dermally, or transdermally
7. Current use of medications or supplements that may interfere with the results of the study, including:
i.Steroids
ii.Hormone-based contraception
iii.Sleeping pills
iv.Homeopathic substances (e.g. Chinese herbs, protein or other powders, and other-the-counter extracts)
v.Stimulants (e.g. Ritalin)
vi.Antidepressants or anti-epileptic medications or centrally acting anti-hypertensive medications
8. Current use of recreational drugs (alcohol intake will be monitored and excluded during the two intervention periods)
9. Unable to consume food containing dairy or nuts
10. Has currently or has a history of any of the following: autoimmune, heart, liver, renal disease, diabetes, or another health condition deemed by the PI to be a contraindication to study participation. History of thyroid disorder is permissible if the patient is biochemically euthyroid on replacement.
Additional Eligibility Criteria to be Met Prior to Start of Intervention(s):
Criteria 1 Habitual energy intake between 35-55 kcal/kg LBM*day
Criteria 2 VO2max less than or equal to 40 ml/kg/min with the option to increase this at the discretion of the PI, depending on the current and past exercise level of the participant.
Criteria 3 Hemoglobin, prolactin and TSH within normal female range for testing laboratory.
Criteria 4 Ovulation confirmed in the cycle before each study intervention by self-reported positive urine test, ultrasound and/or progesterone blood-levels
Principal Investigator
Referral Contact
For more information: