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NCT00187538 · ClinicalTrials.gov registry record · NA

Effect of Dietary Protein Source on Calcium Metabolism

A NA study of Calcium Metabolism, sponsored by University of California, San Francisco.

Completed
Registry status
NA
Development phase
183
Enrollment target
1
Study location

NCT00187538 is a NA study of Calcium Metabolism that has completed, run by University of California, San Francisco. The registered enrollment target is 183 participants. The trial reports 1 study location across 1 state.

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The verdict

NCT00187538, a NA study of Calcium Metabolism, has completed, sponsored by University of California, San Francisco.

COMPLETED
Registry status
NA
Development phase
183 participants
Enrollment target
1
Study location

Study Summary

Osteoporosis is a major health concern worldwide. While there are drugs available for the treatment and prevention of osteoporosis, they are not practical for population-wide prevention efforts. Demonstrating the effectiveness of safe and widely available dietary interventions to prevent osteoporosis could have important public health ramifications. Different food sources of dietary protein may have different effects on bone metabolism. Animal foods provide a dietary acid load that may lead to negative calcium balance and increased bone resorption. In contrast, vegetable sources of protein, while providing some acid due to their protein content, provide proportionally more base that counters the dietary acid load. The effect of dairy products, which are rich in animal protein but also contain potential base precursors not found in vegetable foods, has not been established. Finally, soy protein sources may have a dual benefit: soy foods provide base precursors as well as plant estrogens that may have a beneficial effect on bone. We are resubmitting this proposal to randomize postmenopausal women to one of four diets equal in calories, protein, calcium, and sodium. The diets will differ by having 80 percent of the protein from one of four sources: non-dairy animal, vegetable, dairy, or soy foods, resulting in significant differences among the diets in acid, base, and isoflavone content. All food will be prepared and provided by the General Clinical Research Center. The subjects will consume the diets for 6 weeks with measurements of acid-base status, isoflavone excretion, and calcium metabolism. This will be the first intervention study to examine the effect of different sources of dietary protein in whole foods on calcium metabolism. Eventually our findings could have substantial public health implications and provide a widely available and low risk means to help prevent osteoporosis.

Conditions Studied

Interventions

  • BEHAVIORAL Dietary

Study Locations (1)

Maryland

  • Johns Hopkins University - Baltimore

Trial Details

FieldValue
Enrollment Target 183 participants
Start Date 2002-02
Est. Completion 2013-07
Phase NA

What the Registry Record Tells You About NCT00187538

The ClinicalTrials.gov registry entry for NCT00187538 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 183 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Calcium Metabolism appearing as the primary indexed condition, and to 1 intervention - of which Dietary is the first listed.

NCT00187538 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT00187538 about?

NCT00187538 is a clinical study titled "Effect of Dietary Protein Source on Calcium Metabolism". Osteoporosis is a major health concern worldwide. While there are drugs available for the treatment and prevention of osteoporosis, they are not practical for population-wide prevention efforts. Demonstrating the effectiveness of safe and widely available dietary interventions to prevent osteoporosi...

What is the current status of trial NCT00187538?

This trial is currently completed. It is a NA study. The enrollment target is 183 participants. The study started on 2002-02. Estimated completion is 2013-07.

What conditions does trial NCT00187538 study?

This clinical trial studies the following conditions: Calcium Metabolism.

What interventions are being tested in trial NCT00187538?

The interventions under investigation include: Dietary (BEHAVIORAL).

Who is sponsoring clinical trial NCT00187538?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00187538 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.