Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00472680
Status:
TERMINATED
Last Update Posted:
2022-02-01
First Post:
2007-05-10
Brief Title:
The Effect of Severe Weight Loss and Protein Intake on Bone
Sponsor:
Rutgers University
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
Nutritional Regulation of Bone - Aim 2
Status:
TERMINATED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding didnt support further recruitment
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 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 loss This study will examine usual and higher dietary protein intake during severe weight loss following weight loss surgery on bone turnover mass and quality in women with the hypothesis that higher protein intake will reduce bone turnover and loss andor prevent the changes in bone quality associated with severe weight loss in women ages 18 to 70 years
Participants will be randomly assigned to one of 2 groups A weight loss with recommended level of protein intake or B weight loss with higher protein intake A dietitian will provide instructions for a reduced calorie well balanced diet throughout the 12-month study using a nutrition-education behavior- modification program Participants will have the opportunity to speak with the dietitian about their diet by phone or on-site twice per month In addition they will be asked to take a daily vitaminmineral supplement and depending on their usual food intake they may be asked to take a calcium tablet to meet the recommended intake throughout the study period Bone mineral protein and lipid markers and hormones that influence bones will be measured These measurements will provide information about body composition fat muscle mass and bone mineral density
Participants will be randomly assigned to one of 2 groups A weight loss with recommended level of protein intake or B weight loss with higher protein intake A dietitian will provide instructions for a reduced calorie well balanced diet throughout the 12-month study using a nutrition-education behavior- modification program Participants will have the opportunity to speak with the dietitian about their diet by phone or on-site twice per month In addition they will be asked to take a daily vitaminmineral supplement and depending on their usual food intake they may be asked to take a calcium tablet to meet the recommended intake throughout the study period Bone mineral protein and lipid markers and hormones that influence bones will be measured These measurements will provide information about body composition fat muscle mass and bone mineral density
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R01AG012161 | NIH | None | httpsreporternihgovquickSearch5R01AG012161 |