Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00392873
Status:
COMPLETED
Last Update Posted:
2017-05-08
First Post:
2006-10-25
Brief Title:
Increased Calorie Intake to Reverse Energy Deficiency in Exercising Women Impact on Bone and Menstrual Cyclicity
Sponsor:
Penn State University
Organization:
Penn State University
Study Overview
Official Title:
REFUEL Active Womens Study II Increased Caloric Intake to Reverse Energy Deficiency in Exercising Women Impact on Bone and Menstrual Cyclicity
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 will examine whether a 12 month period of increased food intake will cause menstrual cycles to resume and help bones get stronger
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 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None