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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. |
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| 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. |
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| 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 |
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| 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:
Exclusion Criteria:
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| 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 † |
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| Information Provided By | National Institute on Aging (NIA) | ||||
| Verification Date | August 2007 | ||||
| First Received Date † | May 10, 2007 | ||||
| Last Updated Date | August 2, 2007 | ||||