Status:
TERMINATED
The Effect of Severe Weight Loss and Protein Intake on Bone
Lead Sponsor:
Rutgers University
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Weight Loss
Eligibility:
FEMALE
18-70 years
Phase:
NA
Brief Summary
The purpose of this study is to learn whether the amount of dietary protein can influence bone health during the weight loss after weight loss surgery.
Detailed Description
It is unclear whether the amount of protein in the diet during caloric restriction influences bone density. This information is important for determining optimal nutrient requirements during weight lo...
Eligibility Criteria
Inclusion
- Women ages 18 to 70 who are undergoing gastric bypass surgery
- Must live in the geographic vicinity of Rutgers University
Exclusion
- Currently on any medication known to influence calcium or bone metabolism, including HRT, or with evidence of diseases known to influence calcium metabolism (i.e. metabolic bone disease, hyperparathyroidism, untreated thyroid disease, significant immune, hepatic, or renal disease, significant cardiac disease \[i.e., heart attack or stroke in the past 6 months., abnormal EKG\], active malignancy or cancer therapy within the past year)
- History of kidney stones
- Weight gain or weight loss (5% of body wt) within 3 months prior to recruitment
- Participation in other investigational studies during the 12-month study period
- Usually have a very high or low intake of calcium (more than 1500 or less than 500 mg per day)
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00472680
Start Date
March 1 2010
End Date
January 1 2016
Last Update
February 1 2022
Active Locations (1)
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1
Rutgers University
New Brunswick, New Jersey, United States, 08901