The Effect of Severe Weight Loss and Protein Intake on Bone

This study is currently recruiting participants.
Verified July 2012 by Rutgers University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sue Shapses, Rutgers University
ClinicalTrials.gov Identifier:
NCT00472680
First received: May 10, 2007
Last updated: July 2, 2012
Last verified: July 2012
  Purpose

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
Weight Loss
Dietary Protein
Behavioral: Caloric restriction, high protein
Behavioral: Caloric restriction; normal protein
Behavioral: Nutrition Education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Nutritional Regulation of Bone - Aim 2

Resource links provided by NLM:


Further study details as provided by Rutgers University:

Primary Outcome Measures:
  • Changes in Bone mineral density and quality [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in serum and urine bone markers, hormones, and proteins [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 38
Study Start Date: March 2008
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
High Dietary Protein
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
Active Comparator: 2
Normal Dietary Protein
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

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, 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).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women ages 18 to 70 who are undergoing gastric bypass surgery
  • Must live in the geographic vicinity of Rutgers University

Exclusion Criteria:

  • 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00472680

Locations
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         
Sponsors and Collaborators
Rutgers University
Investigators
Principal Investigator: Sue A. Shapses, PhD, RD Rutgers University, Nutritional Sciences
  More Information

Publications:
Responsible Party: Sue Shapses, Professor, Rutgers University
ClinicalTrials.gov Identifier: NCT00472680     History of Changes
Other Study ID Numbers: AG0082, 5R01AG012161, RO1-AG012161
Study First Received: May 10, 2007
Last Updated: July 2, 2012
Health Authority: United States: Federal Government

Keywords provided by Rutgers University:
bone mass
calcium absorption
bone quality
fracture risk

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014