View Clinical Trial (Medical Research Study)

The Effect of Weight Loss and Dietary Protein Intake on Bone - NCT00473031-08901(Clinical Trial 169898)



ClinicalConnection.com has recently undergone an update and this page may no longer be up-to-date. Please Search For Clinical Trials to view the most current clinical trials listings.


Signup
City:  New Brunswick
State:  
NJ
Zip Code: 08901
Conditions: Weight Loss - Bone Density
Purpose: The purpose of this study is to learn how the amount of protein during moderate weight loss influences bone health.
Study summary: 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.
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)
Study is available at: Rutgers University
New Brunswick, NJ 08901
United States

Primary Contact:
Sue Shapses, PhD, RD
Email: shapses@aesop.rutgers.edu
Phone: 732-932-9403
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
Trials Alerts: If you would like to be notified of new clinical trials as they become available please register for a free account.
Data Source: ClinicalTrials.gov
Date Processed: March 22, 2011
Modifications to
this listing:		 Only selected fields are shown, please use the link above to view all information about this clinical trial.