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The Effect of Weight Loss and Dietary Protein Intake on Bone
This study is currently recruiting participants.
Study NCT00473031   Information provided by National Institute on Aging (NIA)
First Received: May 10, 2007   Last Updated: June 30, 2009   History of Changes

May 10, 2007
June 30, 2009
March 2007
May 2011   (final data collection date for primary outcome measure)
Changes in Bone density and quality [ Time Frame: one year ] [ Designated as safety issue: No ]
Changes in Bone density and quality [ Time Frame: one year ]
Complete list of historical versions of study NCT00473031 on ClinicalTrials.gov Archive Site
Changes in serum and urine bone markers, hormones, and proteins [ Time Frame: one year ] [ Designated as safety issue: No ]
Changes in serum and urine bone markers, hormones, and proteins [ Time Frame: one year ]
 
The Effect of Weight Loss and Dietary Protein Intake on Bone
Nutritional Regulation of Bone - Aim 1

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

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.

 
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
  • Weight Loss
  • Bone Density
  • Behavioral: Caloric restriction, high protein
  • Behavioral: Caloric restriction; normal protein
  • Behavioral: Counseling
  • Experimental: High Protein
  • Active Comparator: Normal Protein

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
48
May 2011
May 2011   (final data collection date for primary outcome measure)

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)
Female
50 Years to 70 Years
Yes
 
United States
 
NCT00473031
Sue Shapses, PhD, RD, Rutgers University
AG0079, RO1-AG12161
National Institute on Aging (NIA)
Rutgers University
Principal Investigator: Sue A. Shapses, PhD, RD Rutgers University, Nutritional Sciences
National Institute on Aging (NIA)
June 2009

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