Increased Calorie Intake to Reverse Energy Deficiency in Exercising Women: Impact on Bone and Menstrual Cyclicity
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|ClinicalTrials.gov Identifier: NCT00392873|
Recruitment Status : Completed
First Posted : October 26, 2006
Last Update Posted : May 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Menstrual Irregularity||Behavioral: EAMD+Calories||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||233 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||"REFUEL" Active Women's Study II: Increased Caloric Intake to Reverse Energy Deficiency in Exercising Women: Impact on Bone and Menstrual Cyclicity|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
This group contains women with exercise-associated menstrual disturbances (EAMD) and receives an intervention of increased caloric intake during the 12-month intervention. The targeted increase in caloric intake is 20-30% of baseline energy expenditure.
During the 12 month intervention, volunteers in the Increased calorie intake group will follow a modified dietary plan designed to achieve and maintain a target level of 20-30% above their previously determined baseline, in an effort to achieve a chronic energy surplus of +20-30% over their baseline energy requirements.
No Intervention: EAMD Control
This group contains women with exercise-associated menstrual disturbances (EAMD) and undergoes the same procedures as the EAMD+Calories group. However, this group is instructed to maintain exercise and eating habits.
No Intervention: Heathy Control
This group contains exercising women with regular, ovulatory menstrual cycles. this group is instructed to maintain body weight and exercise and eating habits.
- Reproductive hormones [ Time Frame: 1 year ]
- Metabolic hormones [ Time Frame: 1 year ]
- Metabolic bone markers [ Time Frame: 1 year ]
- Bone mineral density [ Time Frame: 1 year ]
- Eating Disorder Inventory-2 (EDI-2) [ Time Frame: 1 year ]
- Three Factor Eating Questionnaire [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00392873
|United States, Pennsylvania|
|Women's Health and Exercise Laboratories, The Pennsylvania State University|
|University Park, Pennsylvania, United States, 16802|
|Principal Investigator:||Mary Jane De Souza, Ph.D.||Penn State University|