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Long-term Nutritional Intervention Study to Determine How Protein Affects Calcium Metabolism

2014-08-27 03:30:52 | BioPortfolio

Summary

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.

Description

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Osteoporosis

Intervention

Low protein diet

Location

Yale New Haven Hospital Research Unit
New Haven
Connecticut
United States
06510

Status

Completed

Source

Yale University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:30:52-0400

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Medical and Biotech [MESH] Definitions

Reduction of bone mass without alteration in the composition of bone, leading to fractures. Primary osteoporosis can be of two major types: postmenopausal osteoporosis (OSTEOPOROSIS, POSTMENOPAUSAL) and age-related or senile osteoporosis.

A diet that contains limited amounts of protein. It is prescribed in some cases to slow the progression of renal failure. (From Segen, Dictionary of Modern Medicine, 1992)

A diet that consists mainly of foods with a high content of protein and limited amounts of CARBOHYDRATES.

A diet that includes foods with a high protein content.

A diet that contains limited amounts of CARBOHYDRATES. This is in distinction to a regular DIET.

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