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The Effect of Severe Weight Loss and Protein Intake on Bone

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2012 by Sue Shapses, Rutgers University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00472680
First Posted: May 14, 2007
Last Update Posted: July 15, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Sue Shapses, Rutgers University
May 10, 2007
May 14, 2007
July 15, 2014
March 2008
May 2015   (Final data collection date for primary outcome measure)
Changes in Bone mineral density and quality [ Time Frame: one year ]
Changes in Bone density and quality [ Time Frame: one year ]
Complete list of historical versions of study NCT00472680 on ClinicalTrials.gov Archive Site
Changes in serum and urine bone markers, hormones, and proteins [ Time Frame: one year ]
Same as current
Not Provided
Not Provided
 
The Effect of Severe Weight Loss and Protein Intake on Bone
Nutritional Regulation of Bone - Aim 2
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.

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).

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Weight Loss
  • Dietary Protein
  • Behavioral: Caloric restriction, high protein
    Weight loss with higher protein (35%) intake
  • 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
  • Experimental: 1
    High Dietary Protein
    Interventions:
    • Behavioral: Caloric restriction, high protein
    • Behavioral: Nutrition Education
  • Active Comparator: 2
    Normal Dietary Protein
    Interventions:
    • Behavioral: Caloric restriction; normal protein
    • Behavioral: Nutrition Education

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
38
December 2015
May 2015   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: Female
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00472680
AG0082
5R01AG012161 ( U.S. NIH Grant/Contract )
R01AG012161 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Sue Shapses, Rutgers University
Rutgers University
National Institute on Aging (NIA)
Principal Investigator: Sue A. Shapses, PhD, RD Rutgers University, Nutritional Sciences
Rutgers University
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP