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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00260286 |
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Date of registration:
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30/11/2005 |
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Primary sponsor: |
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Public title:
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Effects of Gynecological Age on LH Sensitivity to Energy Availability
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Scientific title:
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Dietary Energy Requirements in Physically Active Men and Women, Objective 4B: Effects of Gynecological Age on LH Sensitivity to Energy Availability |
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Date of first enrolment:
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August 2001 |
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Target sample size:
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18 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00260286 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention
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Countries of recruitment
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United States
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Contacts
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Name:
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Anne B Loucks, Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ohio University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 5-8 or 14-18 years of gynecological age
- menstrual cycles of 26 to 32 days for the previous 3 months
- luteal phase length >11 days
- 18-32% body fat
Exclusion Criteria:
- smoking
- oral contraceptives
- hematocrit <35%
- diet with <35 or >55 kcal/kgFFM/day of energy
- habitually performing more than 60 minutes/week of aerobic exercise
- histories or evidence of heart, liver, or kidney disease, diabetes, menstrual or
thyroid disorders, pregnancy, lactation, and congenital or acquired orthopedic
abnormalities
Age minimum:
18 Years
Age maximum:
34 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Amenorrhea
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Anovulation
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Infertility
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Starvation
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Intervention(s)
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Behavioral: Energy availability
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Primary Outcome(s)
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Differences in 24h LH pulse frequency, 24h LH pulse amplitude and 24h LH mean concentration in blood samples drawn q10' for 24 hours after 5 days of treatment
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Secondary Outcome(s)
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Differences in 24h average glucose, beta-hydroxybutyrate, insulin, cortisol, growth hormone, insulin-like growth factor-I, tri-iodothyronine, and leptin concentrations in blood samples drawn q10' for 24 hours after 5 days of treatment
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Secondary ID(s)
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DAMD_17-95-1-5053,
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Excalibur X
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M01_RR00034
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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