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Long-term Impact of Protein on Calcium Kinetics
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.
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.
Age
20 - 40 years
Sex
FEMALE
Healthy Volunteers
Yes
Yale New Haven Hospital Research Unit
New Haven, Connecticut, United States
Start Date
May 1, 2003
Primary Completion Date
October 1, 2009
Completion Date
April 1, 2010
Last Updated
March 31, 2020
11
ACTUAL participants
Low protein diet
OTHER
Lead Sponsor
Yale University
Collaborators
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT07281586