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Sponsors and Collaborators: |
Yale University United States Department of Agriculture |
Information provided by: | Yale University |
ClinicalTrials.gov Identifier: | NCT00671944 |
Osteoporosis is a major health problem in men and women in this country and the incidence of this disease is rising. We think that environmental factors such as nutrition may play a role in the increasing prevalence of osteoporosis. In particular, we think that a diet that is too low in protein may be contributing to bone loss. The primary purpose of this study is to compare the long-term impact of a low protein diet on measures of bone and calcium metabolism.
Condition | Intervention | Phase |
Osteoporosis |
Other: Low protein diet |
Phase I |
MedlinePlus related topics: | Osteoporosis |
ChemIDplus related topics: | Parathyroid Calcium gluconate |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | Long-Term Impact of Protein on Calcium Kinetics |
Estimated Enrollment: | 16 |
Study Start Date: | May 2003 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
Low protein diet
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Other: Low protein diet
Low protein diet for 6.5 weeks
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The protocol is composed of a 9.5-week study, consisting of a 3-week adjustment period followed by a 6.5-week experimental period. During the adjustment period, subjects consume a well-balanced lead-in diet designed to stabilize baseline Ca homeostasis. In the subsequent experimental period, subjects will consume the experimental diet containing 0.7 g protein/kg, 800-1200 mg phosphorus, 800 mg calcium and 2300 mg sodium. During days -6 to -1 of the adjustment diet, 5-10 and days 40-45 of the experimental period, we will measure Ca absorption and kinetics. Weekly assessments of Ca homeostasis will be done using our standard measures of calcitropic hormones, markers of bone turnover, and urine and serum minerals.
Ages Eligible for Study: | 20 Years to 40 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Irina Rosewater, MD | 203-785-5457 | irina.rosewater@yale.edu |
Contact: Rebecca R Sullivan, MS, RD | 203-737-1656 | becky.sullivan@yale.edu |
United States, Connecticut | |||||
Yale New Haven Hospital Research Unit | Recruiting | ||||
New Haven, Connecticut, United States, 06510 |
Yale University |
United States Department of Agriculture |
Principal Investigator: | Karl L Insogna, MD | Yale University |
Responsible Party: | Yale University ( Karl Insogna, MD ) |
Study ID Numbers: | 00-35200-9579 |
First Received: | May 1, 2008 |
Last Updated: | May 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00671944 |
Health Authority: | United States: Institutional Review Board |
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