OsteoporosisSoyPTINCT00661856
Effect of Soy Isoflavones on Bone Mineral Density and Physical Performance Indices
A study testing Soy protein in people with Osteoporosis, run by Creighton University at 1 site in United States.
Trial summary
The aim of the present study was to investigate the effects of soy and soy plus isoflavones on bone mineral Density and physical performance in post menopausal women. Read more about this study
- Who is it for?
- Ages 55 to 72 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Soy protein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 203 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2001to Jan 2004
- 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 to 72 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- at least 55-75 years of age
- at least 7 years post menopausal either spontaneous or surgical
Who cannot join
- must not have used estrogen for atleast 2 months prior to entering study
- must be on no bone active drugs such as bisphosphonates, anti convulsants, calcitonin and long term steroids
- osteoporosis (T-score<-2.5)
- BMI <18 or >34
Trial locations and contacts
1 site in 1 country.
United States1 site
Creighton University Medical Center
Omaha, Nebraska, 68131
About this study
Official title: The Effect of Increased Soy Protein Intake on Bone Metabolism
The aim of the present study was to investigate the effects of soy and soy plus isoflavones on bone mineral Density and physical performance in post menopausal women.
Read the detailed description
Post menopausal estrogen deficiency causes physiologic changes in body composition including decreased lean body weight and bone mass. A decrease in muscle strength along with osteoporosis puts post menopausal women at a high risk of hip fractures causing considerable mortality and morbidity. Estrogen use has been shown to reduce bone density loss and increase muscle strength but given the concerns regarding its use, patients are looking for alternatives such as Soy isoflavones. Most human studies on the effect of Soy on bone mineral density (BMD) in post menopausal women have been short term i.e. 3-6 months and failed to provide conclusive evidence. There is no evidence of its effects on physical performance.
The aim of the present study is to investigate the effects of 25g of soy protein alone or with 90mg of isoflavones on bone mineral Density and physical performance indices in post menopausal women over a duration of 2 years.
- Conditions
- Osteoporosis
- Being tested
- Soy protein
- Keywords
- Soy Isoflavones, Bone Mineral Density, Post menopausal women
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soy proteinDietary supplement
Also called genistein, daidzein, glycetein
25g of Soy protein with or with out 90mg of isoflavones ones a day given for a period of 24 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Soy Protein group 25g of Soy protein with no Isoflavones Receives: Dietary Supplement: Soy protein |
| 2 | Experimental | Soy Isoflavone group 25g of Soy Protein with 90mg of Isoflavones Receives: Dietary Supplement: Soy protein |
| 3 | Placebo comparator | 25g of Milk protein Receives: Dietary Supplement: Soy protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Mineral Density
Measured: 24 months
Secondary outcomes (1)
Physical Performance Indices
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2008 (estimated)
- Study startJan 2001
- Primary completionJan 2004
- Study completionJan 2004
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 OsteoporosisStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Collaborators
- Solae, LLC
- Investigators
- J C Gallagher, Principal investigator, Creighton University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00661856
- Sponsor's protocol ID
- 0012254
- Acronym
- SoyPTI
- Status last verified
- Apr 2008
- First submitted
- 17 Apr 2008
- Last updated
- 21 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gallagher JC, Satpathy R, Rafferty K, Haynatzka V. The effect of soy protein isolate on bone metabolism. Menopause. 2004 May-Jun;11(3):290-8. doi: 10.1097/01.gme.0000097845.95550.71.
PubMed 15167308
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Increased Soy Protein Intake on Bone Metabolism
- ClinicalTrials.gov ID
- NCT00661856
- Acronym / sponsor ID
- SoyPTI / 0012254
- Conditions
- Osteoporosis
- Keywords
- Soy Isoflavones, Bone Mineral Density, Post menopausal women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Collaborators
- Solae, LLC
- Study start
- Jan 2001
- Primary completion
- Jan 2004 (actual)
- Study completion
- Jan 2004 (actual)
- First posted
- 21 Apr 2008 (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.
The aim of the present study was to investigate the effects of soy and soy plus isoflavones on bone mineral Density and physical performance in post menopausal women.
Detailed description
Post menopausal estrogen deficiency causes physiologic changes in body composition including decreased lean body weight and bone mass. A decrease in muscle strength along with osteoporosis puts post menopausal women at a high risk of hip fractures causing considerable mortality and morbidity. Estrogen use has been shown to reduce bone density loss and increase muscle strength but given the concerns regarding its use, patients are looking for alternatives such as Soy isoflavones. Most human studies on the effect of Soy on bone mineral density (BMD) in post menopausal women have been short term i.e. 3-6 months and failed to provide conclusive evidence. There is no evidence of its effects on physical performance.
The aim of the present study is to investigate the effects of 25g of soy protein alone or with 90mg of isoflavones on bone mineral Density and physical performance indices in post menopausal women over a duration of 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: Soy proteinSoy Protein group 25g of Soy protein with no Isoflavones |
| 2 | Experimental | Dietary Supplement: Soy proteinSoy Isoflavone group 25g of Soy Protein with 90mg of Isoflavones |
| 3 | Placebo comparator | Dietary Supplement: Soy protein25g of Milk protein |
Who may qualify
- Ages
- 55 to 72 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- at least 55-75 years of age
- at least 7 years post menopausal either spontaneous or surgical
Key exclusion criteria (4 listed)
- must not have used estrogen for atleast 2 months prior to entering study
- must be on no bone active drugs such as bisphosphonates, anti convulsants, calcitonin and long term steroids
- osteoporosis (T-score<-2.5)
- BMI <18 or >34
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 |
|---|---|---|
| Soy proteinAlso: genistein, daidzein, glycetein25g of Soy protein with or with out 90mg of isoflavones ones a day given for a period of 24 months | Dietary supplement | 1, 2, 3 |
Primary outcome
Bone Mineral Density
Time frame: 24 months
1 secondary outcome
Physical Performance Indices
Time frame: 24 months
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 Apr 2008.
- Background: PubMed 15167308Gallagher JC, Satpathy R, Rafferty K, Haynatzka V. The effect of soy protein isolate on bone metabolism. Menopause. 2004 May-Jun;11(3):290-8. doi: 10.1097/01.gme.0000097845.95550.71.
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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.
J C Gallagher principal investigator
Creighton University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soy protein in people with Osteoporosis, run by Creighton University 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 2 inclusion and 4 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 Apr 2008. 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. Some participants in this study may receive a placebo. 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?
Bone Mineral Density (time frame: 24 months). 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 NCT00661856, 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 Apr 2008.