Type 2 DiabetesNCT01754662
Effects of Combining Cocoa and Soy in Type 2 Diabetes
A study testing Soy protein, Isoflavones and Cocoa in people with Type 2 Diabetes and Dietary Intervention, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Diabetes is an increasingly common condition affecting millions of people world wide. The cornerstone of treatment is lifestyle that includes looking at the way how people eat. It is known that food containing compounds called polyphenols can reduce the risk of heart disease risk in people with diabetes. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Type 2 Diabetes, Dietary Intervention
- What is being tested?
- Soy protein, Isoflavones and Cocoa
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2011to Jun 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with type 2 diabetes controlled by diet or metformin only
- Stable medication history for 3 months prior to screening visit
- Age 45-80
Who cannot join
- Patients with concurrent illness or any medication (especially antibiotics)3 months prior to enrollment that would effect the study results based on investigator's judgement
- Patients not wishing to allow disclosure to their GPs
- Pre-menopausal women or on hormone replacement therapy
- HbA1c >9% at screening
- Patients with known food allergies
- Smokers
- Vegans and vegetarians
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Michael White Diabetes Centre
Hull, North Humberside, HU3 2RW
About this study
Official title: A Pilot Study Investigating the Effects of the Combined Effects of Cocoa and Soy Polyphenols in a Soy Protein Matrix on Insulin Resistance and Cardiovascular Disease Risk in Type 2 Diabetes - A Randomised Placebo-Controlled Double-Blind Parallel Study
Diabetes is an increasingly common condition affecting millions of people world wide. The cornerstone of treatment is lifestyle that includes looking at the way how people eat. It is known that food containing compounds called polyphenols can reduce the risk of heart disease risk in people with diabetes. Two foods that are rich sources of polyphenols are cocoa (epicatechins) and soy (isoflavones). Previous studies have shown the benefits of these foods in the diets of people with diabetes. It has also been shown that soy isoflavones and cocoa polyphenols can improve the mood in certain groups of patients.
What is not known is whether there is any extra benefit of combining soy protein and isoflavones with cocoa.
The aim of the study is to look at the modification of cardiovascular risk by soy and/or cocoa in patients with type 2 diabetes, alone or in combination.
Read the detailed description
- General information about the study The target number of participants is 100. All participants are patients with type 2 diabetes on diet alone or metformin treatment. Participants will be asked to eat two soy bars daily for 8 weeks. The length of the study is 10 weeks and involves 4 visits at the Diabetes Research Centre in Hull, UK. The bars will contain:
- soy protein alone, or
- soy protein with additional isoflavones, or
- soy protein with cocoa, or
- soy protein with isoflavones and cocoa, or
- placebo bars without soy protein, isoflavones or cocoa. The study is randomised (a computer based allocation schema will be used to decide which bars the participant will need to consume). Participants have the same 20% chance to be participant of any of the above groups. The study is placebo-controlled (there is one arm of placebo bars without soy protein, additional isoflavones or cocoa). The study is double-blind (neither the participants or the research team will know which bars they will take).
- Study-specific procedures
Visit 1 (week 0). Non-fasting visit. Interested participants discuss the study with a member of the study team who will explain each aspect of the study, following which informed consent will be then obtained. Subsequently, blood pressure, weight, height and waist circumference will be measured, medical history and list of medication are recorded, and blood is taken to determine eligibility. A dietitian will explain about eating a normal diet and the foods we would like the participants to avoid during the study. Vegetarian patients may include too much soy in the diet and for this reason they will not be able to take part in the study. All participants will be non smokers.
Visit 2 (week 2)and Visit 4 (week 10). Fasting visits. Fasting blood is taken and the EndoPAT is performed. Weight, height and waist circumference measurement performed. The EndoPAT test takes between 20-30 minutes. The first box of study bars is dispensed during visit 2. Participants need to consume two bars daily. All remaining uneaten bars and empty wrappers will be collected during visit 4.
Visit 3 (week 6). Non-fasting visit. Height, weight, abdominal circumference, blood pressure are measured. Second box of study bars is dispensed.
Participants are asked to complete a one week food diary and a three day hunger questionnaire before the fasting blood tests. The food diary includes mood rating scales to assess the effect of the consumption of the bars on mood. Participants need to complete these prior to Visit 2 and visit 4.
Participants have 24 hours blood pressure measurement prior to Visit 2 and Visit 4.
24 hours urine collection also takes place prior to visit 2 and visit 4.
- Optional test incorporated into the study: Body Volume Index measurement Based on participants preference, Body Volume Index measurement is offered as a complementary tool to assess body shape and weight.
- Conditions
- Type 2 Diabetes, Dietary Intervention
- Being tested
- Soy protein, Isoflavones, Cocoa, Placebo
- Keywords
- Type 2 diabetes, Cardiovascular risk, Endothelial function, Insulin resistance, Soy, Isoflavones, Cocoa, Diet
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soy proteinDietary supplement
2 bars daily for 8 weeks.
IsoflavonesDietary supplement
2 bars daily for 8 weeks.
CocoaDietary supplement
2 bars daily for 8 weeks.
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Soy protein with isoflavones and cocoa | Experimental | Soy protein with isoflavones and cocoa bars. 2 bars daily for 8 weeks. Receives: Dietary Supplement: Soy protein; Dietary Supplement: Isoflavones; Dietary Supplement: Cocoa |
| Soy protein alone with cocoa | Experimental | Soy protein alone with cocoa with no isoflavones. 2 bars daily for 8 weeks. Receives: Dietary Supplement: Soy protein; Dietary Supplement: Cocoa |
| Soy protein with soy isoflavones | Experimental | Soy protein with isoflavones bar. 2 bars daily for 8 weeks. Receives: Dietary Supplement: Soy protein; Dietary Supplement: Isoflavones |
| Soy protein alone | Experimental | Soy protein alone without soy isoflavone or cocoa polyphenol. 2 bars daily for 8 weeks. Receives: Dietary Supplement: Soy protein |
| Placebo | Placebo comparator | Placebo bar without soy protein, isoflavones or cocoa polyphenols. 2 bars daily for 8 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin resistance, lipid profile
Soy with isoflavones and cocoa polyphenols have a greater impact on insulin resistance, lipid parameters in type 2 diabetes than seen with soy protein alone, soy protein with isoflavones and soy protein with cocoa polyphenols.
Measured: 8 weeks
Secondary outcomes (3)
Cardiovascular risk
Soy with isoflavones reduces cardiovascular risk as measured by fasting lipids and blood pressure
Measured: 8 weeks
Isoflavones
Soy with isoflavones increases plasma isoflavones
Measured: 8 weeks
Endothelial function
Soy and cocoa improves endothelial function
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2012 (estimated)
- Study startOct 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hull University Teaching Hospitals NHS Trust
- Sponsor type
- Other government
- Collaborators
- University of Hull
- Responsible party
- Sponsor
- Investigators
- Stephen Atkin, Principal investigator, University of Hull
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01754662
- Sponsor's protocol ID
- R1188
- Status last verified
- Jul 2019
- First submitted
- 18 Dec 2012
- Last updated
- 15 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Anderson JW, Smith BM, Washnock CS. Cardiovascular and renal benefits of dry bean and soybean intake. Am J Clin Nutr. 1999 Sep;70(3 Suppl):464S-474S. doi: 10.1093/ajcn/70.3.464s.
PubMed 10479219Vedavanam K, Srijayanta S, O'Reilly J, Raman A, Wiseman H. Antioxidant action and potential antidiabetic properties of an isoflavonoid-containing soyabean phytochemical extract (SPE). Phytother Res. 1999 Nov;13(7):601-8. doi: 10.1002/(sici)1099-1573(199911)13:73.0.co;2-o.
PubMed 10548755Lee DS, Lee SH. Genistein, a soy isoflavone, is a potent alpha-glucosidase inhibitor. FEBS Lett. 2001 Jul 13;501(1):84-6. doi: 10.1016/s0014-5793(01)02631-x.
PubMed 11457461Sorenson RL, Brelje TC, Roth C. Effect of tyrosine kinase inhibitors on islets of Langerhans: evidence for tyrosine kinases in the regulation of insulin secretion. Endocrinology. 1994 Apr;134(4):1975-8. doi: 10.1210/endo.134.4.8137766.
PubMed 8137766Wagner JD, Cefalu WT, Anthony MS, Litwak KN, Zhang L, Clarkson TB. Dietary soy protein and estrogen replacement therapy improve cardiovascular risk factors and decrease aortic cholesteryl ester content in ovariectomized cynomolgus monkeys. Metabolism. 1997 Jun;46(6):698-705. doi: 10.1016/s0026-0495(97)90016-0.
PubMed 9186308Duncan AM, Underhill KE, Xu X, Lavalleur J, Phipps WR, Kurzer MS. Modest hormonal effects of soy isoflavones in postmenopausal women. J Clin Endocrinol Metab. 1999 Oct;84(10):3479-84. doi: 10.1210/jcem.84.10.6067.
PubMed 10522983Goodman-Gruen D, Kritz-Silverstein D. Usual dietary isoflavone intake is associated with cardiovascular disease risk factors in postmenopausal women. J Nutr. 2001 Apr;131(4):1202-6. doi: 10.1093/jn/131.4.1202.
PubMed 11285326Hermansen K, Sondergaard M, Hoie L, Carstensen M, Brock B. Beneficial effects of a soy-based dietary supplement on lipid levels and cardiovascular risk markers in type 2 diabetic subjects. Diabetes Care. 2001 Feb;24(2):228-33. doi: 10.2337/diacare.24.2.228.
PubMed 11213870Tsai AC, Vinik AI, Lasichak A, Lo GS. Effects of soy polysaccharide on postprandial plasma glucose, insulin, glucagon, pancreatic polypeptide, somatostatin, and triglyceride in obese diabetic patients. Am J Clin Nutr. 1987 Mar;45(3):596-601. doi: 10.1093/ajcn/45.3.596.
PubMed 2881482Jayagopal V, Albertazzi P, Kilpatrick ES, Howarth EM, Jennings PE, Hepburn DA, Atkin SL. Beneficial effects of soy phytoestrogen intake in postmenopausal women with type 2 diabetes. Diabetes Care. 2002 Oct;25(10):1709-14. doi: 10.2337/diacare.25.10.1709.
PubMed 12351466Chedraui P, San Miguel G, Hidalgo L, Morocho N, Ross S. Effect of Trifolium pratense-derived isoflavones on the lipid profile of postmenopausal women with increased body mass index. Gynecol Endocrinol. 2008 Nov;24(11):620-4. doi: 10.1080/09513590802288283.
PubMed 19031218Scholey AB, French SJ, Morris PJ, Kennedy DO, Milne AL, Haskell CF. Consumption of cocoa flavanols results in acute improvements in mood and cognitive performance during sustained mental effort. J Psychopharmacol. 2010 Oct;24(10):1505-14. doi: 10.1177/0269881109106923. Epub 2009 Nov 26.
PubMed 19942640Konya J, Sathyapalan T, Kilpatrick ES, Atkin SL. The Effects of Soy Protein and Cocoa With or Without Isoflavones on Glycemic Control in Type 2 Diabetes. A Double-Blind, Randomized, Placebo-Controlled Study. Front Endocrinol (Lausanne). 2019 May 9;10:296. doi: 10.3389/fendo.2019.00296. eCollection 2019.
PubMed 31143160
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Investigating the Effects of the Combined Effects of Cocoa and Soy Polyphenols in a Soy Protein Matrix on Insulin Resistance and Cardiovascular Disease Risk in Type 2 Diabetes - A Randomised Placebo-Controlled Double-Blind Parallel Study
- ClinicalTrials.gov ID
- NCT01754662
- Acronym / sponsor ID
- R1188
- Conditions
- Type 2 Diabetes, Dietary Intervention
- Keywords
- Type 2 diabetes, Cardiovascular risk, Endothelial function, Insulin resistance, Soy, Isoflavones, Cocoa, Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Hull University Teaching Hospitals NHS TrustOther government
- Collaborators
- University of Hull
- Study start
- Oct 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 21 Dec 2012 (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.
Diabetes is an increasingly common condition affecting millions of people world wide. The cornerstone of treatment is lifestyle that includes looking at the way how people eat. It is known that food containing compounds called polyphenols can reduce the risk of heart disease risk in people with diabetes. Two foods that are rich sources of polyphenols are cocoa (epicatechins) and soy (isoflavones). Previous studies have shown the benefits of these foods in the diets of people with diabetes. It has also been shown that soy isoflavones and cocoa polyphenols can improve the mood in certain groups of patients.
What is not known is whether there is any extra benefit of combining soy protein and isoflavones with cocoa.
The aim of the study is to look at the modification of cardiovascular risk by soy and/or cocoa in patients with type 2 diabetes, alone or in combination.
Detailed description
- General information about the study The target number of participants is 100. All participants are patients with type 2 diabetes on diet alone or metformin treatment. Participants will be asked to eat two soy bars daily for 8 weeks. The length of the study is 10 weeks and involves 4 visits at the Diabetes Research Centre in Hull, UK. The bars will contain:
- soy protein alone, or
- soy protein with additional isoflavones, or
- soy protein with cocoa, or
- soy protein with isoflavones and cocoa, or
- placebo bars without soy protein, isoflavones or cocoa. The study is randomised (a computer based allocation schema will be used to decide which bars the participant will need to consume). Participants have the same 20% chance to be participant of any of the above groups. The study is placebo-controlled (there is one arm of placebo bars without soy protein, additional isoflavones or cocoa). The study is double-blind (neither the participants or the research team will know which bars they will take).
- Study-specific procedures
Visit 1 (week 0). Non-fasting visit. Interested participants discuss the study with a member of the study team who will explain each aspect of the study, following which informed consent will be then obtained. Subsequently, blood pressure, weight, height and waist circumference will be measured, medical history and list of medication are recorded, and blood is taken to determine eligibility. A dietitian will explain about eating a normal diet and the foods we would like the participants to avoid during the study. Vegetarian patients may include too much soy in the diet and for this reason they will not be able to take part in the study. All participants will be non smokers.
Visit 2 (week 2)and Visit 4 (week 10). Fasting visits. Fasting blood is taken and the EndoPAT is performed. Weight, height and waist circumference measurement performed. The EndoPAT test takes between 20-30 minutes. The first box of study bars is dispensed during visit 2. Participants need to consume two bars daily. All remaining uneaten bars and empty wrappers will be collected during visit 4.
Visit 3 (week 6). Non-fasting visit. Height, weight, abdominal circumference, blood pressure are measured. Second box of study bars is dispensed.
Participants are asked to complete a one week food diary and a three day hunger questionnaire before the fasting blood tests. The food diary includes mood rating scales to assess the effect of the consumption of the bars on mood. Participants need to complete these prior to Visit 2 and visit 4.
Participants have 24 hours blood pressure measurement prior to Visit 2 and Visit 4.
24 hours urine collection also takes place prior to visit 2 and visit 4.
- Optional test incorporated into the study: Body Volume Index measurement Based on participants preference, Body Volume Index measurement is offered as a complementary tool to assess body shape and weight.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Soy protein with isoflavones and cocoa | Experimental | Dietary Supplement: Soy protein, Dietary Supplement: Isoflavones, Dietary Supplement: CocoaSoy protein with isoflavones and cocoa bars. 2 bars daily for 8 weeks. |
| Soy protein alone with cocoa | Experimental | Dietary Supplement: Soy protein, Dietary Supplement: CocoaSoy protein alone with cocoa with no isoflavones. 2 bars daily for 8 weeks. |
| Soy protein with soy isoflavones | Experimental | Dietary Supplement: Soy protein, Dietary Supplement: IsoflavonesSoy protein with isoflavones bar. 2 bars daily for 8 weeks. |
| Soy protein alone | Experimental | Dietary Supplement: Soy proteinSoy protein alone without soy isoflavone or cocoa polyphenol. 2 bars daily for 8 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo bar without soy protein, isoflavones or cocoa polyphenols. 2 bars daily for 8 weeks |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with type 2 diabetes controlled by diet or metformin only
- Stable medication history for 3 months prior to screening visit
- Age 45-80
Key exclusion criteria (7 listed)
- Patients with concurrent illness or any medication (especially antibiotics)3 months prior to enrollment that would effect the study results based on investigator's judgement
- Patients not wishing to allow disclosure to their GPs
- Pre-menopausal women or on hormone replacement therapy
- HbA1c >9% at screening
- Patients with known food allergies
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 protein2 bars daily for 8 weeks. | Dietary supplement | Soy protein alone, Soy protein alone with cocoa, Soy protein with isoflavones and cocoa, Soy protein with soy isoflavones |
| Isoflavones2 bars daily for 8 weeks. | Dietary supplement | Soy protein with isoflavones and cocoa, Soy protein with soy isoflavones |
| Cocoa2 bars daily for 8 weeks. | Dietary supplement | Soy protein alone with cocoa, Soy protein with isoflavones and cocoa |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Insulin resistance, lipid profile
Time frame: 8 weeks
Soy with isoflavones and cocoa polyphenols have a greater impact on insulin resistance, lipid parameters in type 2 diabetes than seen with soy protein alone, soy protein with isoflavones and soy protein with cocoa polyphenols.
3 secondary outcomes
Cardiovascular risk
Time frame: 8 weeks
Isoflavones
Time frame: 8 weeks
Endothelial function
Time frame: 8 weeks
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 15 Jul 2019.
- Background: PubMed 10479219Anderson JW, Smith BM, Washnock CS. Cardiovascular and renal benefits of dry bean and soybean intake. Am J Clin Nutr. 1999 Sep;70(3 Suppl):464S-474S. doi: 10.1093/ajcn/70.3.464s.
- Background: PubMed 10548755Vedavanam K, Srijayanta S, O'Reilly J, Raman A, Wiseman H. Antioxidant action and potential antidiabetic properties of an isoflavonoid-containing soyabean phytochemical extract (SPE). Phytother Res. 1999 Nov;13(7):601-8. doi: 10.1002/(sici)1099-1573(199911)13:73.0.co;2-o.
- Background: PubMed 11457461Lee DS, Lee SH. Genistein, a soy isoflavone, is a potent alpha-glucosidase inhibitor. FEBS Lett. 2001 Jul 13;501(1):84-6. doi: 10.1016/s0014-5793(01)02631-x.
- Background: PubMed 8137766Sorenson RL, Brelje TC, Roth C. Effect of tyrosine kinase inhibitors on islets of Langerhans: evidence for tyrosine kinases in the regulation of insulin secretion. Endocrinology. 1994 Apr;134(4):1975-8. doi: 10.1210/endo.134.4.8137766.
- Background: PubMed 9186308Wagner JD, Cefalu WT, Anthony MS, Litwak KN, Zhang L, Clarkson TB. Dietary soy protein and estrogen replacement therapy improve cardiovascular risk factors and decrease aortic cholesteryl ester content in ovariectomized cynomolgus monkeys. Metabolism. 1997 Jun;46(6):698-705. doi: 10.1016/s0026-0495(97)90016-0.
- Background: PubMed 10522983Duncan AM, Underhill KE, Xu X, Lavalleur J, Phipps WR, Kurzer MS. Modest hormonal effects of soy isoflavones in postmenopausal women. J Clin Endocrinol Metab. 1999 Oct;84(10):3479-84. doi: 10.1210/jcem.84.10.6067.
- Background: PubMed 11285326Goodman-Gruen D, Kritz-Silverstein D. Usual dietary isoflavone intake is associated with cardiovascular disease risk factors in postmenopausal women. J Nutr. 2001 Apr;131(4):1202-6. doi: 10.1093/jn/131.4.1202.
- Background: PubMed 11213870Hermansen K, Sondergaard M, Hoie L, Carstensen M, Brock B. Beneficial effects of a soy-based dietary supplement on lipid levels and cardiovascular risk markers in type 2 diabetic subjects. Diabetes Care. 2001 Feb;24(2):228-33. doi: 10.2337/diacare.24.2.228.
- Background: PubMed 2881482Tsai AC, Vinik AI, Lasichak A, Lo GS. Effects of soy polysaccharide on postprandial plasma glucose, insulin, glucagon, pancreatic polypeptide, somatostatin, and triglyceride in obese diabetic patients. Am J Clin Nutr. 1987 Mar;45(3):596-601. doi: 10.1093/ajcn/45.3.596.
- Background: PubMed 12351466Jayagopal V, Albertazzi P, Kilpatrick ES, Howarth EM, Jennings PE, Hepburn DA, Atkin SL. Beneficial effects of soy phytoestrogen intake in postmenopausal women with type 2 diabetes. Diabetes Care. 2002 Oct;25(10):1709-14. doi: 10.2337/diacare.25.10.1709.
- Background: PubMed 19031218Chedraui P, San Miguel G, Hidalgo L, Morocho N, Ross S. Effect of Trifolium pratense-derived isoflavones on the lipid profile of postmenopausal women with increased body mass index. Gynecol Endocrinol. 2008 Nov;24(11):620-4. doi: 10.1080/09513590802288283.
- Background: PubMed 19942640Scholey AB, French SJ, Morris PJ, Kennedy DO, Milne AL, Haskell CF. Consumption of cocoa flavanols results in acute improvements in mood and cognitive performance during sustained mental effort. J Psychopharmacol. 2010 Oct;24(10):1505-14. doi: 10.1177/0269881109106923. Epub 2009 Nov 26.
- publication linkLink provided by the sponsor.
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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.
Stephen Atkin principal investigator
University of Hull
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, Isoflavones and Cocoa in people with Type 2 Diabetes and Dietary Intervention, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
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 3 inclusion and 7 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 15 Jul 2019. 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 Kingdom. 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?
Insulin resistance, lipid profile (time frame: 8 weeks). 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 NCT01754662, which also lists 13 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 15 Jul 2019.