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The Effect of Weight Loss and Dietary Protein Intake on Bone

This study is currently recruiting participants.
Information provided by National Institute on Aging (NIA)

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Descriptive Information Fields
Brief Title  The Effect of Weight Loss and Dietary Protein Intake on Bone
Official Title  Nutritional Regulation of Bone - Aim 1
Brief Summary

The purpose of this study is to learn how the amount of protein during moderate weight loss influences bone health.

Detailed Description

It is unclear whether protein intake during dieting influences bone density. This information is important for determining optimal nutrient requirements during weight loss. This study will compare the effects of weight loss with a lower-carbohydrate, high-protein (HP) diet to a high-carbohydrate, moderate protein (HC) diet on bone mass and quality in postmenopausal women (ages 50-70 years) with the hypothesis that bone turnover and loss of bone will be reduced on the HP compared to the HC weight loss diet. Bone loss will be partially explained by changes in fat mass and estrogen levels.

Participants will be randomly assigned to one of 2 groups: A) weight loss with recommended level of protein intake, and B) weight loss with higher protein intake. All participants will attend regular counseling sessions (about 50 minutes per session) with a dietitian for approximately 1 year, and will be asked to take a daily vitamin/mineral supplement. Also, 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 asked to attend 8 diet counseling sessions, with the opportunity to attend a total of approximately 28 diet counseling sessions during the year.

Study Phase
Study Type  Interventional
Study Design  Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure  Changes in Bone density and quality [ Time Frame: one year ]
Secondary Outcome Measure  Changes in serum and urine bone markers, hormones, and proteins [ Time Frame: one year ]
Condition  Weight Loss
Bone Density
Intervention  Behavioral: Caloric restriction, high protein
MEDLINE PMIDs 16702302,   15746990,   15213038,   14742841
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  48
Start Date  March 2007
Completion Date May 2011
Eligibility Criteria 

Inclusion Criteria:

  • Postmenopausal women who are more than 2 years since last menses
  • Obese or overweight
  • 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)
Gender Female
Ages 50 Years to 70 Years
Accepts Healthy Volunteers Yes
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00473031
Organization ID AG0079
Secondary IDs †† RO1-AG12161
Study Sponsor  National Institute on Aging (NIA)
Collaborators †† Rutgers University
Investigators 
Principal Investigator:     Sue A. Shapses, PhD, RD     Rutgers University, Nutritional Sciences    
Information Provided By National Institute on Aging (NIA)
Verification Date August 2007
First Received Date  May 10, 2007
Last Updated Date August 2, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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