Status:
COMPLETED
Increased Calorie Intake to Reverse Energy Deficiency in Exercising Women: Impact on Bone and Menstrual Cyclicity
Lead Sponsor:
Penn State University
Collaborating Sponsors:
United States Department of Defense
Conditions:
Menstrual Irregularity
Eligibility:
FEMALE
18-35 years
Phase:
NA
Brief Summary
The purpose of this study is to examine the effects of increased food intake on the menstrual cycle and bone health in physically active women who have irregular or absent menstrual cycles. This study...
Detailed Description
Low levels of estrogen found in physically active, premenopausal women with irregular or absent menstrual periods is likely caused by insufficient energy (calorie) intake compared to energy expenditur...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Ovulatory Control Volunteers:
- 18-35 years
- BMI 16-25 kg/m2
- At least 2 hr/wk of aerobic exercise
- Gynecological age \>/= 5 years
- Weight stable (+/- 2 kg) last 6 months
- History of regular menses for 6 months
- Inclusion Criteria for Women with Irregular or Absent Menses:
- 18-35 years
- BMI 16-25 kg/m2
- At least 3 hr/wk of aerobic exercise
- Gynecological age \>/= 5 years
- Weight stable (+/- 2 kg) last 6 months
- No menses within past 3 months or 6 or less menses in last 12 months
- Low to normal bone mass (L1-L4 Z score \</=0)
- Exclusion Criteria for all participants:
- Hormonal contraceptives in last 6 months
- Smoking currently
- Current clinical diagnosis of an eating disorder
- Use of medications incompatible with measurement of reproductive or metabolic hormones, including thyroid medications that may interfere with any of the study outcomes.
- Dietary habits incompatible with prescribed diet for study
- Any metabolic, reproductive or bone disease
- Sedentary individuals with less than 120 minutes (2 hrs) of activity per week
Exclusion
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
233 Patients enrolled
Trial Details
Trial ID
NCT00392873
Start Date
September 1 2006
End Date
December 1 2014
Last Update
May 8 2017
Active Locations (1)
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1
Women's Health and Exercise Laboratories, The Pennsylvania State University
University Park, Pennsylvania, United States, 16802