View Clinical Trial (Medical Research Study)
"REFUEL" Active Women's Study II: Increased Caloric Intake to Reverse Energy Deficiency in Exercising Women: Impact on Bone and Menstrual Cyclicity
| City: |
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University Park |
| State: |
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Pennsylvania |
| Zip Code: |
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16802 |
| Conditions: |
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Menstrual Irregularity |
| Purpose: |
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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 will examine whether a 12 month period of increased food
intake will cause menstrual cycles to resume and help bones get stronger.
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| Study Summary: |
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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 expenditure. Premenopausal women with menstrual disturbances and amenorrhea suffer
from reductions in bone mineral density, particularly in the lumbar spine. Bone loss
observed in amenorrheic women may be serious enough to result in osteoporotic fractures, but
is also associated with a high prevalence of stress fractures. Increased calorie intake
should help improve energy status, menstrual status, and bone health.
Comparison: Premenopausal women with irregular or absent menstrual periods will be assigned
to either receive additional calories or serve as controls. A group of premenopausal women
with normal menstrual periods will also be used for comparison.
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| Criteria: |
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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
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| NCT ID: |
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NCT00392873 |
| Primary Contact: |
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Principal Investigator
Mary Jane De Souza, Ph.D.
Penn State University
Darcy Gungor, M.Sc.
Phone: 814-867-2294
Email: deg182@psu.edu
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| Backup Contact: |
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Email: rjt199@psu.edu
Rebecca J Toombs, B.Sc.
Phone: 814-867-2510
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| Location Contact: |
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University Park, Pennsylvania 16802
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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