- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00187538
Effect of Dietary Protein Source on Calcium Metabolism
August 20, 2014 updated by: University of California, San Francisco
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.
Study Overview
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
183
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21224
- Johns Hopkins University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
Healthy postmenopausal women
Exclusion Criteria:
No meds affecting bone Normal renal, GI, hepatic function
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 2
|
dietary
|
Active Comparator: 1
|
dietary
|
Active Comparator: 3
|
dietary
|
Active Comparator: 4
|
dietary
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
calcium metabolism
Time Frame: after 8 weeks of diet
|
after 8 weeks of diet
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Deborah Sellmeyer, MD, Johns Hopkins University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2002
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
July 1, 2013
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 16, 2005
Study Record Updates
Last Update Posted (Estimate)
August 21, 2014
Last Update Submitted That Met QC Criteria
August 20, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- H9291-19207-05
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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