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Sponsors and Collaborators: |
National Institute on Aging (NIA) Rutgers University |
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Information provided by: | National Institute on Aging (NIA) |
ClinicalTrials.gov Identifier: | NCT00472680 |
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.
Condition | Intervention |
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Weight Loss Bone Density Bariatric Surgery |
Behavioral: Caloric restriction, high protein Behavioral: Caloric restriction; normal protein Behavioral: Nutrition Education |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Nutritional Regulation of Bone - Aim 2 |
Estimated Enrollment: | 38 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | May 2011 |
Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
High Protein
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Behavioral: Caloric restriction, high protein
Weight loss with higher protein (35%) intake
Behavioral: Nutrition Education
Participants will have the opportunity to speak with the dietitian about their diet by phone, or on-site twice per month
|
2: Active Comparator
Normal Protein
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Behavioral: Caloric restriction; normal protein
Weight loss with normal level of protein (18%) intake
Behavioral: Nutrition Education
Participants will have the opportunity to speak with the dietitian about their diet by phone, or on-site twice per month
|
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, and/or 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 vitamin/mineral 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).
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New Jersey | |
Rutgers University | Recruiting |
New Brunswick, New Jersey, United States, 08901 | |
Contact: Sue Shapses, PhD, RD 732-932-9403 shapses@aesop.rutgers.edu | |
Contact: Hasina Ambia-Sobhan 732-932-6656 togore@rci.rutgers.edu | |
Principal Investigator: Sue A. Shapses, PhD, RD | |
Sub-Investigator: Stephen Schneider, MD | |
Sub-Investigator: Robert Brolin, MD |
Principal Investigator: | Sue A. Shapses, PhD, RD | Rutgers University, Nutritional Sciences |
Responsible Party: | Rutgers University ( Sue Shapses, PhD, RD ) |
Study ID Numbers: | AG0082, RO1-AG012161 |
Study First Received: | May 10, 2007 |
Last Updated: | September 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00472680 |
Health Authority: | United States: Federal Government |
bone mass calcium absorption bone quality fracture risk |
Body Weight Calcium, Dietary Signs and Symptoms |
Weight Loss Fractures, Bone Body Weight Changes |