OsteoporosisPhase 4NCT00668447
Soy and Isoflavones Effect on Bone
A Phase 4 study testing Soy Isolate and Novasoy isoflavones in people with Osteoporosis, run by United States Department of Agriculture (USDA) at 1 site in United States.
Trial summary
The purpose of this study is to test the effect of 1 year of added dietary soy protein and/or soy isoflavones on bone mineral density in late postmenopausal women. Read more about this study
- Who is it for?
- Ages 65 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Soy Isolate and Novasoy isoflavones
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2001to Jun 2005
- Phase
- Phase 4
- 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 65 years and older
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Postmenopausal women 65 years old or older
- Able to travel to the clinical sites for follow-up visits
Who cannot join
- History of disease that may affect bone metabolism (including Paget's disease, primary hyperparathyroidism, osteomalacia, untreated hyperthyroidism, or multiple myeloma)
- Cancer of any kind (except basal or squamous cell of skin) in past 5 years
- Use of any of the following medications within the past 2 years: calcitonin, calcitriol, heparin, phenytoin, phenobarbital
- Use at any time of bisphosphonates, long-term corticosteroids (over 6 months), methotrexate, or fluoride
- Estimated creatinine clearance less than 50 ml/min
- History of chronic liver disease or evidence of liver disease on screening
Show all 9Show fewer
- History of hip fracture
- Known vertebral fracture within the past year
- Vegans
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecticut Health Center
Farmington, Connecticut, 06030
About this study
Official title: Soy Proteins and Isoflavones Impact Bone Mineral Density in Older Women
The purpose of this study is to test the effect of 1 year of added dietary soy protein and/or soy isoflavones on bone mineral density in late postmenopausal women.
Read the detailed description
Although soy foods contain several components (isoflavones and amino acids) that could potentially have positive effects on bone health, there are few long term, large, clinical trials using soy as a means of improving bone mineral density. The objective of this study is to provide daily soy protein and isoflavones to healthy older women in order to answer three major questions:
- Does soy protein alone affect bone metabolism?
- Do isoflavones, given with soy protein, affect bone metabolism?
- What dose of isoflavones affects bone in older women?
We hypothesize that soy protein will have a beneficial effect on bone in older women compared to control protein. Further, we hypothesize that there will be an additional benefit to bone in women who receive soy protein plus isoflavones (at both doses) compared to soy protein alone.
Both control and soy proteins used in the study were isolates, meaning they were the highest concentration of protein (85-90% by weight) in order to minimize the volume of protein supplement that each woman was asked to ingest on a daily basis. The soy protein was an alcohol-washed, soy protein isolate containing 90% protein and negligible isoflavone (0.2 mg/g product). The control protein was a mix consisting of 50% protein from sodium caseinate, 25% protein from whey protein and 25% from egg white protein. The use of a mix of proteins as a control provides a more balanced level of amino acids, mimics the real life mix of proteins that humans typically consume, and avoids the unique characteristics of one source of protein. In order to maintain the dietary protein intake constant, the participant was counseled to decrease her intake of other sources of protein from primarily animal sources by approximately 3 ounces per day (the approximate equivalent of the protein powders). The isoflavones tablets each contained 57 mg of total isoflavone from primarily genistein, glycitein, and daidzein and their beta-glycosides.
- Conditions
- Osteoporosis
- Being tested
- Soy Isolate, Control protein, Novasoy isoflavones, Placebo tablets
- Keywords
- bone density, bone loss, postmenopausal
- Medical subject headings
- Osteoporosis, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soy IsolateDietary supplement
Also called Pro Fam 930, 066-930
20 grams of powder mixed in beverages or food daily for one year
Control proteinDietary supplement
20 grams of powder mixed in beverages or food daily for one year
Novasoy isoflavonesDietary supplement
3 tablets daily for one year
Placebo tabletsDietary supplement
3 tablets daily for one year
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Soy protein and isoflavone tablets Receives: Dietary Supplement: Soy Isolate; Dietary Supplement: Novasoy isoflavones |
| 2 | Active comparator | Soy protein and placebo tablets Receives: Dietary Supplement: Soy Isolate; Dietary Supplement: Placebo tablets |
| 3 | Active comparator | control protein and Isoflavone tablets Receives: Dietary Supplement: Control protein; Dietary Supplement: Novasoy isoflavones |
| 4 | Placebo comparator | control protein and placebo tablets Receives: Dietary Supplement: Control protein; Dietary Supplement: Placebo tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone turnover markers
Measured: baseline, 3 months, and 1 year
Secondary outcomes (5)
Bone Mineral Density
Measured: Baseline, 6 and 12 months
Quality of life measured by Medical Outcomes Short Form
Measured: Baseline, 6 and 12 months
Medication Side Effects
Measured: 3 , 6, 9, and 12 months
Adherence to dietary intervention through the use of 24-hour recall
Measured: 3, 6, 9, and 12 months
Long-term medication behavior self-efficacy scale
Measured: 3, 6, 9, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2008 (estimated)
- Study startNov 2001
- Primary completionJun 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Department of Agriculture (USDA)
- Sponsor type
- US federal agency
- Collaborators
- University of Connecticut
- Investigators
- Jane Kerstetter, PhD, Principal investigator, Department of Allied Health Sciences, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00668447
- Sponsor's protocol ID
- AG0102
- Other IDs
- USDA CONR-2001-00630
- Status last verified
- Apr 2008
- First submitted
- 25 Apr 2008
- Last updated
- 29 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Evans EM, Racette SB, Van Pelt RE, Peterson LR, Villareal DT. Effects of soy protein isolate and moderate exercise on bone turnover and bone mineral density in postmenopausal women. Menopause. 2007 May-Jun;14(3 Pt 1):481-8. doi: 10.1097/01.gme.0000243570.78570.f7.
PubMed 17213752Alekel DL, Germain AS, Peterson CT, Hanson KB, Stewart JW, Toda T. Isoflavone-rich soy protein isolate attenuates bone loss in the lumbar spine of perimenopausal women. Am J Clin Nutr. 2000 Sep;72(3):844-52. doi: 10.1093/ajcn/72.3.844.
PubMed 10966908Arjmandi BH, Lucas EA, Khalil DA, Devareddy L, Smith BJ, McDonald J, Arquitt AB, Payton ME, Mason C. One year soy protein supplementation has positive effects on bone formation markers but not bone density in postmenopausal women. Nutr J. 2005 Feb 23;4:8. doi: 10.1186/1475-2891-4-8.
PubMed 15727682Kenny AM, Mangano KM, Abourizk RH, Bruno RS, Anamani DE, Kleppinger A, Walsh SJ, Prestwood KM, Kerstetter JE. Soy proteins and isoflavones affect bone mineral density in older women: a randomized controlled trial. Am J Clin Nutr. 2009 Jul;90(1):234-42. doi: 10.3945/ajcn.2009.27600. Epub 2009 May 27.
PubMed 19474141
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soy Proteins and Isoflavones Impact Bone Mineral Density in Older Women
- ClinicalTrials.gov ID
- NCT00668447
- Acronym / sponsor ID
- AG0102
- Conditions
- Osteoporosis
- Keywords
- bone density, bone loss, postmenopausal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- United States Department of Agriculture (USDA)US federal agency
- Collaborators
- University of Connecticut
- Study start
- Nov 2001
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 29 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 purpose of this study is to test the effect of 1 year of added dietary soy protein and/or soy isoflavones on bone mineral density in late postmenopausal women.
Detailed description
Although soy foods contain several components (isoflavones and amino acids) that could potentially have positive effects on bone health, there are few long term, large, clinical trials using soy as a means of improving bone mineral density. The objective of this study is to provide daily soy protein and isoflavones to healthy older women in order to answer three major questions:
- Does soy protein alone affect bone metabolism?
- Do isoflavones, given with soy protein, affect bone metabolism?
- What dose of isoflavones affects bone in older women?
We hypothesize that soy protein will have a beneficial effect on bone in older women compared to control protein. Further, we hypothesize that there will be an additional benefit to bone in women who receive soy protein plus isoflavones (at both doses) compared to soy protein alone.
Both control and soy proteins used in the study were isolates, meaning they were the highest concentration of protein (85-90% by weight) in order to minimize the volume of protein supplement that each woman was asked to ingest on a daily basis. The soy protein was an alcohol-washed, soy protein isolate containing 90% protein and negligible isoflavone (0.2 mg/g product). The control protein was a mix consisting of 50% protein from sodium caseinate, 25% protein from whey protein and 25% from egg white protein. The use of a mix of proteins as a control provides a more balanced level of amino acids, mimics the real life mix of proteins that humans typically consume, and avoids the unique characteristics of one source of protein. In order to maintain the dietary protein intake constant, the participant was counseled to decrease her intake of other sources of protein from primarily animal sources by approximately 3 ounces per day (the approximate equivalent of the protein powders). The isoflavones tablets each contained 57 mg of total isoflavone from primarily genistein, glycitein, and daidzein and their beta-glycosides.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Soy Isolate, Dietary Supplement: Novasoy isoflavonesSoy protein and isoflavone tablets |
| 2 | Active comparator | Dietary Supplement: Soy Isolate, Dietary Supplement: Placebo tabletsSoy protein and placebo tablets |
| 3 | Active comparator | Dietary Supplement: Control protein, Dietary Supplement: Novasoy isoflavonescontrol protein and Isoflavone tablets |
| 4 | Placebo comparator | Dietary Supplement: Control protein, Dietary Supplement: Placebo tabletscontrol protein and placebo tablets |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Postmenopausal women 65 years old or older
- Able to travel to the clinical sites for follow-up visits
Key exclusion criteria (9 listed)
- History of disease that may affect bone metabolism (including Paget's disease, primary hyperparathyroidism, osteomalacia, untreated hyperthyroidism, or multiple myeloma)
- Cancer of any kind (except basal or squamous cell of skin) in past 5 years
- Use of any of the following medications within the past 2 years: calcitonin, calcitriol, heparin, phenytoin, phenobarbital
- Use at any time of bisphosphonates, long-term corticosteroids (over 6 months), methotrexate, or fluoride
- Estimated creatinine clearance less than 50 ml/min
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 IsolateAlso: Pro Fam 930, 066-93020 grams of powder mixed in beverages or food daily for one year | Dietary supplement | 1, 2 |
| Control protein20 grams of powder mixed in beverages or food daily for one year | Dietary supplement | 3, 4 |
| Novasoy isoflavones3 tablets daily for one year | Dietary supplement | 1, 3 |
| Placebo tablets3 tablets daily for one year | Dietary supplement | 2, 4 |
Primary outcome
Bone turnover markers
Time frame: baseline, 3 months, and 1 year
5 secondary outcomes
Bone Mineral Density
Time frame: Baseline, 6 and 12 months
Quality of life measured by Medical Outcomes Short Form
Time frame: Baseline, 6 and 12 months
Medication Side Effects
Time frame: 3 , 6, 9, and 12 months
Adherence to dietary intervention through the use of 24-hour recall
Time frame: 3, 6, 9, and 12 months
Long-term medication behavior self-efficacy scale
Time frame: 3, 6, 9, and 12 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 29 Apr 2008.
- Background: PubMed 17213752Evans EM, Racette SB, Van Pelt RE, Peterson LR, Villareal DT. Effects of soy protein isolate and moderate exercise on bone turnover and bone mineral density in postmenopausal women. Menopause. 2007 May-Jun;14(3 Pt 1):481-8. doi: 10.1097/01.gme.0000243570.78570.f7.
- Background: PubMed 10966908Alekel DL, Germain AS, Peterson CT, Hanson KB, Stewart JW, Toda T. Isoflavone-rich soy protein isolate attenuates bone loss in the lumbar spine of perimenopausal women. Am J Clin Nutr. 2000 Sep;72(3):844-52. doi: 10.1093/ajcn/72.3.844.
- Background: PubMed 15727682Arjmandi BH, Lucas EA, Khalil DA, Devareddy L, Smith BJ, McDonald J, Arquitt AB, Payton ME, Mason C. One year soy protein supplementation has positive effects on bone formation markers but not bone density in postmenopausal women. Nutr J. 2005 Feb 23;4:8. doi: 10.1186/1475-2891-4-8.
- Derived from this study: PubMed 19474141Kenny AM, Mangano KM, Abourizk RH, Bruno RS, Anamani DE, Kleppinger A, Walsh SJ, Prestwood KM, Kerstetter JE. Soy proteins and isoflavones affect bone mineral density in older women: a randomized controlled trial. Am J Clin Nutr. 2009 Jul;90(1):234-42. doi: 10.3945/ajcn.2009.27600. Epub 2009 May 27.
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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.
Jane Kerstetter, PhD principal investigator
Department of Allied Health Sciences, University of Connecticut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Soy Isolate and Novasoy isoflavones in people with Osteoporosis, run by United States Department of Agriculture (USDA) 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 9 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 29 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 turnover markers (time frame: baseline, 3 months, and 1 year). 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 NCT00668447, which also lists 4 linked publications.
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 29 Apr 2008.