Metabolic Syndrome XNCT01173380
Soy Nut Study on Markers of Health
A study testing Soy nuts and Matched food in people with Metabolic Syndrome X, run by University of California, Davis at 1 site in United States.
Trial summary
The investigators hope to learn about the effects of soy nuts on markers of health. When some people eat soy foods, their gut bacteria make equol. Equol is a soy metabolite (small molecule made during metabolism). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Metabolic Syndrome X
- What is being tested?
- Soy nuts and Matched food
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Sep 2012
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women
- Men ages 45 or above
- Blood pressure greater than or equal to 130/85 mmHg but not greater than 160/100 and meeting an additional 2 of the remaining 4 Metabolic syndrome diagnostic criteria as defined by NCEP ATP III:
- Elevated waist circumference: men equal to or greater than 40 inches, women equal to or greater than 35 inches
- Reduced HDL cholesterol: men less than 40 mg/dL, women less than 50 mg/dL
- Fasting glucose greater than or equal to 100 mg/dL
- Fasting blood triglycerides greater than or equal to 150 mg/dL but less than 400 mg/dL
- Weight of at least 110 pounds
Who cannot join
- Smokers
- Chronic disease, such as diabetes, cancer, renal disease, and blood disorders
- History of intestinal disorders, which affect absorption or transit, such as ulcerative colitis or crohns disease
- Allergy to soy
- Antioxidant supplement usage
Trial locations and contacts
1 site in 1 country.
United States1 site
Ragle Human Nutrition Center
Davis, California, 95616
About this study
Official title: Effects of Soy on Metabolite Markers of Health
The investigators hope to learn about the effects of soy nuts on markers of health. When some people eat soy foods, their gut bacteria make equol. Equol is a soy metabolite (small molecule made during metabolism). The investigators will be testing blood samples to determine if markers of health are different for people who make equol versus people who do not make equol.
Read the detailed description
The objective of the study is to investigate the metabolomic response to consumption of soy protein containing polyphenolic phytochemicals (isoflavones). The aim of this pilot study is to demonstrate proof of concept and ability to detect metabolomic changes that are responsive to soy. This preliminary data will then be used to design future research projects.
Food phytochemicals such as the polyphenolic flavonoids from a wide variety of foods and beverages have been associated with cardiovascular protective effects in epidemiologic studies. Significant controversy exists in the literature regarding the efficacy and mechanisms for the cardiovascular protection of soy foods. The soy hypothesis for cardiovascular risk reduction has been focused mainly on the isoflavone content of soy, but uncertainty still exists regarding the bioactive component(s). In particular, consumption of soy protein foods has been associated with favorable cardiovascular disease (CVD) risk profiles in population based studies. Controlled clinical trials and meta-analyses however, have resulted in the conclusions that soy protein with associated isoflavones has only modest hypocholesterolemic effects in the range of 3-5% reduction in LDL-cholesterol. Additional cardioprotective effects have been demonstrated in clinical trials, promoting small but significant changes in vascular endothelial function and antioxidant protection. An important observation is that animal studies have shown reduction in atherosclerotic lesion size both with and without decreased blood lipid levels. These results taken together suggest that soy and soy phytochemicals can promote positive risk factors and outcomes by mechanisms in addition to, and other than lowering serum cholesterol levels. There is a need for greater understanding of the cellular and molecular mechanisms underlying the physiologic responses to isoflavones in the vascular compartment. Increasing evidence is emerging that biologically relevant concentrations of isoflavones may impact cell signaling processes in vascular and other tissues.
The large body of literature on human clinical trials of soy proteins and isoflavones has focused primarily on traditional lipid and lipoprotein parameters, biomarkers of CVD risk, and functional changes in endothelial function, platelet activation and total blood antioxidant capacity as described above. It is possible and likely that the effect of soy consumption on CVD risk is a net result of multiple subtle changes in metabolic pathways, vascular inflammatory responses and cell-signaling pathways which are not readily detected in healthy individuals. Since individuals with metabolic syndrome (MetS) present with many of the metabolic aberrations purported to be improved through soy food ingestion, these individuals may be an excellent study population in order to investigate the effects of a soy food intervention on metabolic markers of health. Equol is the end-product of daidzein biotransformation, and is produced only by some humans, resulting in a phenotypic characteristic in response to dietary soy. It is hypothesized by some researchers that the "equol producers" may have additional metabolic and phenotypic responses to soy which may help to explain some of the variances in the literature. Few investigators have examined this question in existing studies, with two reporting an association with outcomes and one no association. A recent study using microarray analysis of lymphocytes from postmenopausal women demonstrated differential gene expression in women who form equol compared to those who do not, suggesting that equol status may be an important modulator of responses to soy isoflavones. No studies have examined this question in a metabolomic investigation. This demonstrates a gap in the literature and provides an opportunity to contribute significant novel data using cutting-edge approaches.
- Conditions
- Metabolic Syndrome X
- Being tested
- Soy nuts, Matched food
- Keywords
- Soy, Equol, Metabolic syndrome, Endothelial function
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soy nutsOther
Also called Genisoy
Oil roasted soy nuts with 101 milligrams of soy isoflavones per day for 4 weeks
Matched foodOther
Control food (matched for calories and macronutrients) per day for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Matched food | Sham comparator | Control food (matched for calories and macronutrients) per day for 4 weeks Receives: Other: Matched food |
| Soy nuts | Active comparator | Oil roasted soy nuts with 101 milligrams of soy isoflavones per day for 4 weeks Receives: Other: Soy nuts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improve lipid profile
Total cholesterol, low density lipoprotein cholesterol, high density lipoprotein cholesterol, triglyceride level, apolipoproteinA1, apolipoproteinB100, apolipoproteinB100:apolipoproteinA1, urinary F2-isoprostane
Measured: After 4 week intervention
Increase endothelial function
Brachial artery flow mediated dilation, reactive hyperemia peripheral arterial tonometry, blood pressure, endothelin-1
Measured: After 4 week intervention
Attenuate glycemic responses
Fasting plasma glucose, insulin, fructosamine, homeostasis model assessment of insulin resistance
Measured: After 4 week intervention
Secondary outcomes (2)
Decrease inflammatory markers
High sensitivity C reactive protein, vascular cell adhesion molecule-1, intercellular adhesion molecule-1
Measured: After 4 week intervention
Follow anthropometrics for stable weight
Weight, height, body mass index, waist circumference, hip circumference, waist:hip ratio
Measured: After 4 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Metabolic Syndrome XStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francene M Steinberg, PhD, RD, Principal investigator, UC Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01173380
- Sponsor's protocol ID
- 200715715-4
- Status last verified
- May 2017
- First submitted
- 23 Jul 2010
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Azadbakht L, Kimiagar M, Mehrabi Y, Esmaillzadeh A, Hu FB, Willett WC. Soy consumption, markers of inflammation, and endothelial function: a cross-over study in postmenopausal women with the metabolic syndrome. Diabetes Care. 2007 Apr;30(4):967-73. doi: 10.2337/dc06-2126.
PubMed 17392557Azadbakht L, Kimiagar M, Mehrabi Y, Esmaillzadeh A, Padyab M, Hu FB, Willett WC. Soy inclusion in the diet improves features of the metabolic syndrome: a randomized crossover study in postmenopausal women. Am J Clin Nutr. 2007 Mar;85(3):735-41. doi: 10.1093/ajcn/85.3.735.
PubMed 17344494Bartoli G, Menegaz G, Lisi M, Di Stolfo G, Dragoni S, Gori T. Model-based analysis of flow-mediated dilation and intima-media thickness. Int J Biomed Imaging. 2008;2008:738545. doi: 10.1155/2008/738545. Epub 2009 Apr 6.
PubMed 19360110Bitto A, Altavilla D, Bonaiuto A, Polito F, Minutoli L, Di Stefano V, Giuliani D, Guarini S, Arcoraci V, Squadrito F. Effects of aglycone genistein in a rat experimental model of postmenopausal metabolic syndrome. J Endocrinol. 2009 Mar;200(3):367-76. doi: 10.1677/JOE-08-0206. Epub 2008 Dec 9.
PubMed 19066292Cassidy A, Brown JE, Hawdon A, Faughnan MS, King LJ, Millward J, Zimmer-Nechemias L, Wolfe B, Setchell KD. Factors affecting the bioavailability of soy isoflavones in humans after ingestion of physiologically relevant levels from different soy foods. J Nutr. 2006 Jan;136(1):45-51. doi: 10.1093/jn/136.1.45.
PubMed 16365057Charles C, Yuskavage J, Carlson O, John M, Tagalicud AS, Maggio M, Muller DC, Egan J, Basaria S. Effects of high-dose isoflavones on metabolic and inflammatory markers in healthy postmenopausal women. Menopause. 2009 Mar-Apr;16(2):395-400. doi: 10.1097/gme.0b013e3181857979.
PubMed 18981951Corretti MC, Anderson TJ, Benjamin EJ, Celermajer D, Charbonneau F, Creager MA, Deanfield J, Drexler H, Gerhard-Herman M, Herrington D, Vallance P, Vita J, Vogel R; International Brachial Artery Reactivity Task Force. Guidelines for the ultrasound assessment of endothelial-dependent flow-mediated vasodilation of the brachial artery: a report of the International Brachial Artery Reactivity Task Force. J Am Coll Cardiol. 2002 Jan 16;39(2):257-65. doi: 10.1016/s0735-1097(01)01746-6.
PubMed 11788217de Kleijn MJ, van der Schouw YT, Wilson PW, Grobbee DE, Jacques PF. Dietary intake of phytoestrogens is associated with a favorable metabolic cardiovascular risk profile in postmenopausal U.S.women: the Framingham study. J Nutr. 2002 Feb;132(2):276-82. doi: 10.1093/jn/132.2.276.
PubMed 11823590Donald AE, Halcox JP, Charakida M, Storry C, Wallace SM, Cole TJ, Friberg P, Deanfield JE. Methodological approaches to optimize reproducibility and power in clinical studies of flow-mediated dilation. J Am Coll Cardiol. 2008 May 20;51(20):1959-64. doi: 10.1016/j.jacc.2008.02.044.
PubMed 18482664Grundy SM. Metabolic syndrome pandemic. Arterioscler Thromb Vasc Biol. 2008 Apr;28(4):629-36. doi: 10.1161/ATVBAHA.107.151092. Epub 2008 Jan 3.
PubMed 18174459Hallund J, Bugel S, Tholstrup T, Ferrari M, Talbot D, Hall WL, Reimann M, Williams CM, Wiinberg N. Soya isoflavone-enriched cereal bars affect markers of endothelial function in postmenopausal women. Br J Nutr. 2006 Jun;95(6):1120-6. doi: 10.1079/bjn20061734.
PubMed 16768834Kreijkamp-Kaspers S, Kok L, Bots ML, Grobbee DE, Lampe JW, van der Schouw YT. Randomized controlled trial of the effects of soy protein containing isoflavones on vascular function in postmenopausal women. Am J Clin Nutr. 2005 Jan;81(1):189-95. doi: 10.1093/ajcn/81.1.189.
PubMed 15640479Kressel G, Trunz B, Bub A, Hulsmann O, Wolters M, Lichtinghagen R, Stichtenoth DO, Hahn A. Systemic and vascular markers of inflammation in relation to metabolic syndrome and insulin resistance in adults with elevated atherosclerosis risk. Atherosclerosis. 2009 Jan;202(1):263-71. doi: 10.1016/j.atherosclerosis.2008.04.012. Epub 2008 Apr 20.
PubMed 18501910Li SH, Liu XX, Bai YY, Wang XJ, Sun K, Chen JZ, Hui RT. Effect of oral isoflavone supplementation on vascular endothelial function in postmenopausal women: a meta-analysis of randomized placebo-controlled trials. Am J Clin Nutr. 2010 Feb;91(2):480-6. doi: 10.3945/ajcn.2009.28203. Epub 2009 Nov 18.
PubMed 19923372Maskarinec G, Steude JS, Franke AA, Cooney RV. Inflammatory markers in a 2-year soy intervention among premenopausal women. J Inflamm (Lond). 2009 Apr 7;6:9. doi: 10.1186/1476-9255-6-9.
PubMed 19348684
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Soy on Metabolite Markers of Health
- ClinicalTrials.gov ID
- NCT01173380
- Acronym / sponsor ID
- 200715715-4
- Conditions
- Metabolic Syndrome X
- Keywords
- Soy, Equol, Metabolic syndrome, Endothelial function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 2 Aug 2010 (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 investigators hope to learn about the effects of soy nuts on markers of health. When some people eat soy foods, their gut bacteria make equol. Equol is a soy metabolite (small molecule made during metabolism). The investigators will be testing blood samples to determine if markers of health are different for people who make equol versus people who do not make equol.
Detailed description
The objective of the study is to investigate the metabolomic response to consumption of soy protein containing polyphenolic phytochemicals (isoflavones). The aim of this pilot study is to demonstrate proof of concept and ability to detect metabolomic changes that are responsive to soy. This preliminary data will then be used to design future research projects.
Food phytochemicals such as the polyphenolic flavonoids from a wide variety of foods and beverages have been associated with cardiovascular protective effects in epidemiologic studies. Significant controversy exists in the literature regarding the efficacy and mechanisms for the cardiovascular protection of soy foods. The soy hypothesis for cardiovascular risk reduction has been focused mainly on the isoflavone content of soy, but uncertainty still exists regarding the bioactive component(s). In particular, consumption of soy protein foods has been associated with favorable cardiovascular disease (CVD) risk profiles in population based studies. Controlled clinical trials and meta-analyses however, have resulted in the conclusions that soy protein with associated isoflavones has only modest hypocholesterolemic effects in the range of 3-5% reduction in LDL-cholesterol. Additional cardioprotective effects have been demonstrated in clinical trials, promoting small but significant changes in vascular endothelial function and antioxidant protection. An important observation is that animal studies have shown reduction in atherosclerotic lesion size both with and without decreased blood lipid levels. These results taken together suggest that soy and soy phytochemicals can promote positive risk factors and outcomes by mechanisms in addition to, and other than lowering serum cholesterol levels. There is a need for greater understanding of the cellular and molecular mechanisms underlying the physiologic responses to isoflavones in the vascular compartment. Increasing evidence is emerging that biologically relevant concentrations of isoflavones may impact cell signaling processes in vascular and other tissues.
The large body of literature on human clinical trials of soy proteins and isoflavones has focused primarily on traditional lipid and lipoprotein parameters, biomarkers of CVD risk, and functional changes in endothelial function, platelet activation and total blood antioxidant capacity as described above. It is possible and likely that the effect of soy consumption on CVD risk is a net result of multiple subtle changes in metabolic pathways, vascular inflammatory responses and cell-signaling pathways which are not readily detected in healthy individuals. Since individuals with metabolic syndrome (MetS) present with many of the metabolic aberrations purported to be improved through soy food ingestion, these individuals may be an excellent study population in order to investigate the effects of a soy food intervention on metabolic markers of health. Equol is the end-product of daidzein biotransformation, and is produced only by some humans, resulting in a phenotypic characteristic in response to dietary soy. It is hypothesized by some researchers that the "equol producers" may have additional metabolic and phenotypic responses to soy which may help to explain some of the variances in the literature. Few investigators have examined this question in existing studies, with two reporting an association with outcomes and one no association. A recent study using microarray analysis of lymphocytes from postmenopausal women demonstrated differential gene expression in women who form equol compared to those who do not, suggesting that equol status may be an important modulator of responses to soy isoflavones. No studies have examined this question in a metabolomic investigation. This demonstrates a gap in the literature and provides an opportunity to contribute significant novel data using cutting-edge approaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Matched food | Sham comparator | Other: Matched foodControl food (matched for calories and macronutrients) per day for 4 weeks |
| Soy nuts | Active comparator | Other: Soy nutsOil roasted soy nuts with 101 milligrams of soy isoflavones per day for 4 weeks |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Postmenopausal women
- Men ages 45 or above
- Blood pressure greater than or equal to 130/85 mmHg but not greater than 160/100 and meeting an additional 2 of the remaining 4 Metabolic syndrome diagnostic criteria as defined by NCEP ATP III:
- Weight of at least 110 pounds
Key exclusion criteria (5 listed)
- Smokers
- Chronic disease, such as diabetes, cancer, renal disease, and blood disorders
- History of intestinal disorders, which affect absorption or transit, such as ulcerative colitis or crohns disease
- Allergy to soy
- Antioxidant supplement usage
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 nutsAlso: GenisoyOil roasted soy nuts with 101 milligrams of soy isoflavones per day for 4 weeks | Other | Soy nuts |
| Matched foodControl food (matched for calories and macronutrients) per day for 4 weeks | Other | Matched food |
Primary outcome
Improve lipid profile
Time frame: After 4 week intervention
Total cholesterol, low density lipoprotein cholesterol, high density lipoprotein cholesterol, triglyceride level, apolipoproteinA1, apolipoproteinB100, apolipoproteinB100:apolipoproteinA1, urinary F2-isoprostane
Increase endothelial function
Time frame: After 4 week intervention
Brachial artery flow mediated dilation, reactive hyperemia peripheral arterial tonometry, blood pressure, endothelin-1
Attenuate glycemic responses
Time frame: After 4 week intervention
Fasting plasma glucose, insulin, fructosamine, homeostasis model assessment of insulin resistance
2 secondary outcomes
Decrease inflammatory markers
Time frame: After 4 week intervention
Follow anthropometrics for stable weight
Time frame: After 4 week intervention
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 30 May 2017.
- Background: PubMed 17392557Azadbakht L, Kimiagar M, Mehrabi Y, Esmaillzadeh A, Hu FB, Willett WC. Soy consumption, markers of inflammation, and endothelial function: a cross-over study in postmenopausal women with the metabolic syndrome. Diabetes Care. 2007 Apr;30(4):967-73. doi: 10.2337/dc06-2126.
- Background: PubMed 17344494Azadbakht L, Kimiagar M, Mehrabi Y, Esmaillzadeh A, Padyab M, Hu FB, Willett WC. Soy inclusion in the diet improves features of the metabolic syndrome: a randomized crossover study in postmenopausal women. Am J Clin Nutr. 2007 Mar;85(3):735-41. doi: 10.1093/ajcn/85.3.735.
- Background: PubMed 19360110Bartoli G, Menegaz G, Lisi M, Di Stolfo G, Dragoni S, Gori T. Model-based analysis of flow-mediated dilation and intima-media thickness. Int J Biomed Imaging. 2008;2008:738545. doi: 10.1155/2008/738545. Epub 2009 Apr 6.
- Background: PubMed 19066292Bitto A, Altavilla D, Bonaiuto A, Polito F, Minutoli L, Di Stefano V, Giuliani D, Guarini S, Arcoraci V, Squadrito F. Effects of aglycone genistein in a rat experimental model of postmenopausal metabolic syndrome. J Endocrinol. 2009 Mar;200(3):367-76. doi: 10.1677/JOE-08-0206. Epub 2008 Dec 9.
- Background: PubMed 16365057Cassidy A, Brown JE, Hawdon A, Faughnan MS, King LJ, Millward J, Zimmer-Nechemias L, Wolfe B, Setchell KD. Factors affecting the bioavailability of soy isoflavones in humans after ingestion of physiologically relevant levels from different soy foods. J Nutr. 2006 Jan;136(1):45-51. doi: 10.1093/jn/136.1.45.
- Background: PubMed 18981951Charles C, Yuskavage J, Carlson O, John M, Tagalicud AS, Maggio M, Muller DC, Egan J, Basaria S. Effects of high-dose isoflavones on metabolic and inflammatory markers in healthy postmenopausal women. Menopause. 2009 Mar-Apr;16(2):395-400. doi: 10.1097/gme.0b013e3181857979.
- Background: PubMed 11788217Corretti MC, Anderson TJ, Benjamin EJ, Celermajer D, Charbonneau F, Creager MA, Deanfield J, Drexler H, Gerhard-Herman M, Herrington D, Vallance P, Vita J, Vogel R; International Brachial Artery Reactivity Task Force. Guidelines for the ultrasound assessment of endothelial-dependent flow-mediated vasodilation of the brachial artery: a report of the International Brachial Artery Reactivity Task Force. J Am Coll Cardiol. 2002 Jan 16;39(2):257-65. doi: 10.1016/s0735-1097(01)01746-6.
- Background: PubMed 11823590de Kleijn MJ, van der Schouw YT, Wilson PW, Grobbee DE, Jacques PF. Dietary intake of phytoestrogens is associated with a favorable metabolic cardiovascular risk profile in postmenopausal U.S.women: the Framingham study. J Nutr. 2002 Feb;132(2):276-82. doi: 10.1093/jn/132.2.276.
- Background: PubMed 18482664Donald AE, Halcox JP, Charakida M, Storry C, Wallace SM, Cole TJ, Friberg P, Deanfield JE. Methodological approaches to optimize reproducibility and power in clinical studies of flow-mediated dilation. J Am Coll Cardiol. 2008 May 20;51(20):1959-64. doi: 10.1016/j.jacc.2008.02.044.
- Background: PubMed 18174459Grundy SM. Metabolic syndrome pandemic. Arterioscler Thromb Vasc Biol. 2008 Apr;28(4):629-36. doi: 10.1161/ATVBAHA.107.151092. Epub 2008 Jan 3.
- Background: PubMed 16768834Hallund J, Bugel S, Tholstrup T, Ferrari M, Talbot D, Hall WL, Reimann M, Williams CM, Wiinberg N. Soya isoflavone-enriched cereal bars affect markers of endothelial function in postmenopausal women. Br J Nutr. 2006 Jun;95(6):1120-6. doi: 10.1079/bjn20061734.
- Background: PubMed 15640479Kreijkamp-Kaspers S, Kok L, Bots ML, Grobbee DE, Lampe JW, van der Schouw YT. Randomized controlled trial of the effects of soy protein containing isoflavones on vascular function in postmenopausal women. Am J Clin Nutr. 2005 Jan;81(1):189-95. doi: 10.1093/ajcn/81.1.189.
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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.
Francene M Steinberg, PhD, RD principal investigator
UC Davis
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 nuts and Matched food in people with Metabolic Syndrome X, run by University of California, Davis 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 8 inclusion and 5 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 30 May 2017. 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?
Improve lipid profile (time frame: After 4 week intervention). The study lists 3 primary outcomes in all. 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 NCT01173380, which also lists 25 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 30 May 2017.