Calcium MetabolismNCT00187538
Effect of Dietary Protein Source on Calcium Metabolism
A study testing Dietary in people with Calcium Metabolism, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Calcium Metabolism
- What is being tested?
- Dietary
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2002to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy postmenopausal women
Who cannot join
- No meds affecting bone Normal renal, GI, hepatic function
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Calcium Metabolism
- Being tested
- Dietary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietaryBehavioural
dietary
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Behavioral: Dietary |
| 2 | Active comparator | Not described Receives: Behavioral: Dietary |
| 3 | Active comparator | Not described Receives: Behavioral: Dietary |
| 4 | Active comparator | Not described Receives: Behavioral: Dietary |
What is being measured
The primary outcome is the main question the study is designed to answer.
calcium metabolism
Measured: after 8 weeks of diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startFeb 2002
- Primary completionDec 2012
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Calcium MetabolismStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Deborah Sellmeyer, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00187538
- Sponsor's protocol ID
- H9291-19207-05
- Status last verified
- Aug 2014
- First submitted
- 13 Sep 2005
- Last updated
- 21 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Gonciulea AR, Sellmeyer DE. The effect of dietary protein source on serum lipids: Secondary data analysis from a randomized clinical trial. J Clin Lipidol. 2017 Jan-Feb;11(1):46-54. doi: 10.1016/j.jacl.2016.09.014. Epub 2016 Oct 3.
PubMed 28391910
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dietary Protein Source on Calcium Metabolism
- ClinicalTrials.gov ID
- NCT00187538
- Acronym / sponsor ID
- H9291-19207-05
- Conditions
- Calcium Metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Feb 2002
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Dietary |
| 2 | Active comparator | Behavioral: Dietary |
| 3 | Active comparator | Behavioral: Dietary |
| 4 | Active comparator | Behavioral: Dietary |
Who may qualify
- Ages
- 55 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy postmenopausal women
Key exclusion criteria (1 listed)
- No meds affecting bone Normal renal, GI, hepatic function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietarydietary | Behavioural | 1, 2, 3, 4 |
Primary outcome
calcium metabolism
Time frame: after 8 weeks of diet
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2014.
- Derived from this study: PubMed 28391910Gonciulea AR, Sellmeyer DE. The effect of dietary protein source on serum lipids: Secondary data analysis from a randomized clinical trial. J Clin Lipidol. 2017 Jan-Feb;11(1):46-54. doi: 10.1016/j.jacl.2016.09.014. Epub 2016 Oct 3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah Sellmeyer, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary in people with Calcium Metabolism, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
calcium metabolism (time frame: after 8 weeks of diet). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00187538, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2014.