Type 2 DiabetesPhase 2NCT00410722
Effect of Nuts vs. a Wheat Bran Muffin in Type 2 Diabetes
A Phase 2 study testing Whole wheat and bran muffin and Mixed tree nuts in people with Type 2 Diabetes and Cardiovascular Disease, run by University of Toronto at 1 site in Canada.
Trial summary
To determine if tree nuts (Almonds, Hazelnuts, Pistachios, Peanuts, Macadamia nuts, Pecans, Walnuts and Cashews) improve glycemic control in type 2 diabetes, as assessed by HbA1c and serum fructosamine, and to assess whether these outcomes relate to improvements in cardiovascular health (i.e. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Type 2 Diabetes, Cardiovascular Disease, Diet Therapy
- What is being tested?
- Whole wheat and bran muffin and Mixed tree nuts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2006to Dec 2008
- Phase
- Phase 2
- 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
- Men and post menopausal women with type 2 diabetes treated with diet plus oral hypoglycemic agents (sulfonylureas (glyburide), biguanides (metformin), Thiazolidinediones (TZDs) and new secretagogues (Repaglinide)) at a stable dose for at least 3 months prior to starting the study;
- HbA1c of 6.5 to 8.0% as a compromise between those whose levels are acceptable and the level which is currently considered unacceptable.
- Diabetes diagnosed >6 months prior to randomization
- Weight stable within 3% body weight >2 months.
Who cannot join
- Use of acarbose
- Use of Insulin
- Known nut allergies
- Clinically significant gastroparesis
- Use of steroids
- Presence of GI disease (celiac disease, ulcerative colitis, and Crohns)
Show all 12Show fewer
- Major cardiovascular event (stroke or myocardial infarction)
- Major surgery < 6 months prior to randomization
- Presence of major debilitating disorder such as clinically significant liver disease (not including non-alcoholic fatty liver (NAFL) or non-alcoholic steatohepatitis (NASH) but including cirrhosis, infectious hepatitis (B and C), aspartate transaminase (AST) or alanine transaminase (ALT) > 130 IU/L)
- Renal failure (high creatinine > 150 mmol/L)
- Serum triglyceride > 6 mmol/L.
- Patients currently undergoing treatment for cancer with the exception of non-melanoma skin cancer, but not high risk patients or those whose treatment has been successfully completed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Nuts on Glycemic Control and Cardiovascular Disease Risk in Type 2 Diabetes
To determine if tree nuts (Almonds, Hazelnuts, Pistachios, Peanuts, Macadamia nuts, Pecans, Walnuts and Cashews) improve glycemic control in type 2 diabetes, as assessed by HbA1c and serum fructosamine, and to assess whether these outcomes relate to improvements in cardiovascular health (i.e. plasma lipids and measures of oxidative stress, inflammatory biomarkers and nitric oxide generation). The investigators have found that nuts tend to reduce the glycemic index of bread and have little effect of raising blood glucose on their own. Therefore the investigators believe that they would be ideal foods to displace high glycemic foods from the diet and lower the dietary glycemic load. This will result in improved blood glucose control in type 2 diabetes, with additional benefits on coronary heart disease risk factors due to other effects of nuts.
Read the detailed description
The investigators wish to study the effect of nuts on glycemic control and to confirm their lipid lowering effects in type 2 diabetes. The consumption of nuts with their high unsaturated fat, vegetable protein (arginine) and fiber contents will decrease the glycemic load of the diet and improve glycemic control. The investigators anticipate that the favorable fatty acid profile of nuts along with the vegetable protein will improve the blood lipid profile in type 2 diabetes and thereby establish a cardiovascular risk reduction associated with nuts in this population.
Furthermore, flavonoids and vitamin E present in high concentrations in nuts, and known to have antioxidant activity may help to counter the elevated oxidative stress and inflammation experienced by diabetics. The investigators will therefore determine the effect of nut feeding on measures of oxidative stress (including oxidized low-density lipoprotein cholesterol (LDL-C), considered to be of direct relevance to coronary heart disease), inflammation (C-reactive protein, serum amyloid A and interleukin-6) and nitric oxide metabolism (blood nitric oxide and nitrotyrosine levels). These data would further add to interest in nuts in relation to cardiovascular disease risk reduction and diabetic complications.
Background Diet: A diet conforming to the American Diabetes Association (ADA) and National Cholesterol Education Program (NCEP) Adult Treatment Panel III guidelines. Nuts, soy and dietary supplements (vitamins, minerals, herbal remedies) will be excluded in the background diet during all phases of the study.
Treatment diets:(1) Full-Dose Nut Diet: Raw nuts will be added as supplements to the subject's usual diet. Subjects with calorie needs of 2,400 kcal or greater, assessed by Lipid Research Clinic (LRC) tables, will receive the full-dose supplement (100 g/d of nuts, approximately 600 kcal). Subjects requiring between 1,600-2,400 kcal daily will receive 75% of the full-dose supplement (75 g/d of nuts, approximately 450 kcal). Subjects requiring less than 1,600 kcal daily will receive 50% of the full-dose supplement (50 g/d of nuts, approximately 300 kcal). (2) Half-Dose Nut Diet: Raw nuts will be added as supplements to the subject's usual diet. Subjects with calorie needs of 2,400 kcal or greater, assessed by LRC tables, will receive half of the full dose of the nut supplement (50 g/d of nuts, approximately 300 kcal) with the rest of the calories provided by the muffin (2 muffins are 300 kcal) for a total of 600 kcal. Subjects requiring between 1,600-2,400 kcal daily will receive 75% of the half-dose supplement (37.5 g/d of nuts and 1.5 muffins, approximately 450 kcal). Subjects requiring less than 1,600 kcal daily will receive 50% of the half-dose supplement (25 g/d of nuts and 1 muffin, approximately 300 kcal). (3): The full-dose control supplement will be four 150 kcal muffins. Control supplements will be matched with the energy content of the nut supplements, i.e. either 600 kcal/d (4 muffins); 450 kcal/d (3 muffins); 300 kcal/d (2 muffins). The macronutrient composition of the muffins will conform to an NCEP Step 2 diet with 25% total fat, <7% saturated fat by use of corn oil as the oil commonly used in healthy baked goods, with 18% protein (the average for our subject population) using added skim milk powder, and zero cholesterol. Muffins will be made with whole wheat flour.
Diet History: one-week weighed diet histories will be obtained prior to the start and at weeks 4, 8 and 12 of the study for assessment of macronutrients, dietary fiber and fatty acids.
Palatability/Satiety: for palatability and satiety, subjects will record their ratings using a 7-point bipolar semantic scale at monthly intervals during each study phase.
Anthropometry and Blood Pressure: height at recruitment and body weight, blood pressure, waist and hip circumference, and body composition will be taken immediately prior to and at each clinic visit (wk 0, 2, 4, 8, 10, 12) during the study.
- Conditions
- Type 2 Diabetes, Cardiovascular Disease, Diet Therapy
- Being tested
- Whole wheat and bran muffin, Mixed tree nuts
- Keywords
- Nutrition, Type 2 Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole wheat and bran muffinDietary supplement
Mixed tree nutsDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Full-Dose Nut | Experimental | Subjects will be given tree nuts (almonds, hazelnuts, pistachios, macadamia nuts, pecans, walnuts, and cashews) and peanuts (at a predetermined amount to consume based on their recommended energy intake), and advised to follow a diabetic diet. Receives: Dietary Supplement: Mixed tree nuts |
| Half-Dose Nut | Experimental | Subjects will be given tree nuts (almonds, hazelnuts, pistachios, macadamia nuts, pecans, walnuts, and cashews) and peanuts as well as the control supplement (wheat bran muffin)(at a predetermined amount to consume based on their recommended energy intake), and advised to follow a diabetic diet. Receives: Dietary Supplement: Whole wheat and bran muffin; Dietary Supplement: Mixed tree nuts |
| Control | Active comparator | Subjects will be given a control supplement (wheat bran muffin)(at a predetermined amount to consume based on their recommended energy intake), and advised to follow a diabetic diet. Receives: Dietary Supplement: Whole wheat and bran muffin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Markers of glycemic control: Fasting serum fructosamine
Measured: From prestudy and week 0, to end of treatment weeks 8, 10, 12
Fasting serum HbA1c
Measured: From prestudy and week 0, to end of treatment weeks 8, 10, and 12
Fasting glucose
Measured: From prestudy and week 0, to end of treatment and weeks 8, 10, and 12
Fasting insulin
Measured: From prestudy and week 0, to end of treatment and weeks 8, 10, and 12
Secondary outcomes (13)
24h urinary C-peptide excretion
Measured: From prestudy and week 0, to end of treatment weeks 8, 10, and 12
Branched chain amino acids
Measured: From prestudy and week 0, to end of treatment weeks 8, 10, and 12
Serum triglyceride
Measured: From prestudy and week 0, to end of treatment weeks 8, 10, and 12
Very Low-Density Lipoprotein (VLDL) triglyceride
Measured: From prestudy and week 0, to end of treatment weeks 8, 10, and 12
VLDL-C
Measured: From prestudy and week 0, to end of treatment weeks 8, 10, and 12
LDL:HDL-C
Measured: From prestudy and week 0, to end of treatment weeks 8, 10, and 12
Apolipoprotein B:A1
Measured: From prestudy and week 0, to end of treatment weeks 8, 10, and 12
Lipoprotein(a)
Measured: From prestudy and week 0, to end of treatment weeks 8, 10, and 12
oxidized LDL
Measured: From beginning of study, week 0, to end of treatment week 12
markers of oxidative stress
Measured: From beginning of study, week 0, to end of treatment week 12
C-reactive protein
Measured: From prestudy and week 0, to end of treatment weeks 8, 10, and 12
markers of inflammation
Measured: From prestudy and week 0, to end of treatment weeks 8, 10, and 12
Cancer cell proliferation
Measured: From beginning of study, week 0, to end of treatment week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2006 (estimated)
- Study startDec 2006
- Primary completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of TorontoThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Jenkins, University of Toronto
- Investigators
- David JA Jenkins, MD, PhD, Principal investigator, University of Toronto, St. Michael's HospitalCyril WC Kendall, PhD, Study chair, University of Toronto, St. Michael's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00410722
- Sponsor's protocol ID
- REB 06-274
- Status last verified
- Jan 2013
- First submitted
- 12 Dec 2006
- Last updated
- 9 Jan 2013
- Results posted
- No
Publications
Jenkins DJA, Kendall CWC, Lamarche B, Banach MS, Srichaikul K, Vidgen E, Mitchell S, Parker T, Nishi S, Bashyam B, de Souza RJ, Ireland C, Pichika SC, Beyene J, Sievenpiper JL, Josse RG. Nuts as a replacement for carbohydrates in the diabetic diet: a reanalysis of a randomised controlled trial. Diabetologia. 2018 Aug;61(8):1734-1747. doi: 10.1007/s00125-018-4628-9. Epub 2018 May 23.
PubMed 29789878Nishi SK, Kendall CW, Bazinet RP, Bashyam B, Ireland CA, Augustin LS, Blanco Mejia S, Sievenpiper JL, Jenkins DJ. Nut consumption, serum fatty acid profile and estimated coronary heart disease risk in type 2 diabetes. Nutr Metab Cardiovasc Dis. 2014 Aug;24(8):845-52. doi: 10.1016/j.numecd.2014.04.001. Epub 2014 May 13.
PubMed 24925120Jenkins DJ, Kendall CW, Banach MS, Srichaikul K, Vidgen E, Mitchell S, Parker T, Nishi S, Bashyam B, de Souza R, Ireland C, Josse RG. Nuts as a replacement for carbohydrates in the diabetic diet. Diabetes Care. 2011 Aug;34(8):1706-11. doi: 10.2337/dc11-0338. Epub 2011 Jun 29.
PubMed 21715526
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nuts on Glycemic Control and Cardiovascular Disease Risk in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00410722
- Acronym / sponsor ID
- REB 06-274
- Conditions
- Type 2 Diabetes, Cardiovascular Disease, Diet Therapy
- Keywords
- Nutrition, Type 2 Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Dec 2008 (actual)
- First posted
- 13 Dec 2006 (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.
To determine if tree nuts (Almonds, Hazelnuts, Pistachios, Peanuts, Macadamia nuts, Pecans, Walnuts and Cashews) improve glycemic control in type 2 diabetes, as assessed by HbA1c and serum fructosamine, and to assess whether these outcomes relate to improvements in cardiovascular health (i.e. plasma lipids and measures of oxidative stress, inflammatory biomarkers and nitric oxide generation). The investigators have found that nuts tend to reduce the glycemic index of bread and have little effect of raising blood glucose on their own. Therefore the investigators believe that they would be ideal foods to displace high glycemic foods from the diet and lower the dietary glycemic load. This will result in improved blood glucose control in type 2 diabetes, with additional benefits on coronary heart disease risk factors due to other effects of nuts.
Detailed description
The investigators wish to study the effect of nuts on glycemic control and to confirm their lipid lowering effects in type 2 diabetes. The consumption of nuts with their high unsaturated fat, vegetable protein (arginine) and fiber contents will decrease the glycemic load of the diet and improve glycemic control. The investigators anticipate that the favorable fatty acid profile of nuts along with the vegetable protein will improve the blood lipid profile in type 2 diabetes and thereby establish a cardiovascular risk reduction associated with nuts in this population.
Furthermore, flavonoids and vitamin E present in high concentrations in nuts, and known to have antioxidant activity may help to counter the elevated oxidative stress and inflammation experienced by diabetics. The investigators will therefore determine the effect of nut feeding on measures of oxidative stress (including oxidized low-density lipoprotein cholesterol (LDL-C), considered to be of direct relevance to coronary heart disease), inflammation (C-reactive protein, serum amyloid A and interleukin-6) and nitric oxide metabolism (blood nitric oxide and nitrotyrosine levels). These data would further add to interest in nuts in relation to cardiovascular disease risk reduction and diabetic complications.
Background Diet: A diet conforming to the American Diabetes Association (ADA) and National Cholesterol Education Program (NCEP) Adult Treatment Panel III guidelines. Nuts, soy and dietary supplements (vitamins, minerals, herbal remedies) will be excluded in the background diet during all phases of the study.
Treatment diets:(1) Full-Dose Nut Diet: Raw nuts will be added as supplements to the subject's usual diet. Subjects with calorie needs of 2,400 kcal or greater, assessed by Lipid Research Clinic (LRC) tables, will receive the full-dose supplement (100 g/d of nuts, approximately 600 kcal). Subjects requiring between 1,600-2,400 kcal daily will receive 75% of the full-dose supplement (75 g/d of nuts, approximately 450 kcal). Subjects requiring less than 1,600 kcal daily will receive 50% of the full-dose supplement (50 g/d of nuts, approximately 300 kcal). (2) Half-Dose Nut Diet: Raw nuts will be added as supplements to the subject's usual diet. Subjects with calorie needs of 2,400 kcal or greater, assessed by LRC tables, will receive half of the full dose of the nut supplement (50 g/d of nuts, approximately 300 kcal) with the rest of the calories provided by the muffin (2 muffins are 300 kcal) for a total of 600 kcal. Subjects requiring between 1,600-2,400 kcal daily will receive 75% of the half-dose supplement (37.5 g/d of nuts and 1.5 muffins, approximately 450 kcal). Subjects requiring less than 1,600 kcal daily will receive 50% of the half-dose supplement (25 g/d of nuts and 1 muffin, approximately 300 kcal). (3): The full-dose control supplement will be four 150 kcal muffins. Control supplements will be matched with the energy content of the nut supplements, i.e. either 600 kcal/d (4 muffins); 450 kcal/d (3 muffins); 300 kcal/d (2 muffins). The macronutrient composition of the muffins will conform to an NCEP Step 2 diet with 25% total fat, <7% saturated fat by use of corn oil as the oil commonly used in healthy baked goods, with 18% protein (the average for our subject population) using added skim milk powder, and zero cholesterol. Muffins will be made with whole wheat flour.
Diet History: one-week weighed diet histories will be obtained prior to the start and at weeks 4, 8 and 12 of the study for assessment of macronutrients, dietary fiber and fatty acids.
Palatability/Satiety: for palatability and satiety, subjects will record their ratings using a 7-point bipolar semantic scale at monthly intervals during each study phase.
Anthropometry and Blood Pressure: height at recruitment and body weight, blood pressure, waist and hip circumference, and body composition will be taken immediately prior to and at each clinic visit (wk 0, 2, 4, 8, 10, 12) during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Full-Dose Nut | Experimental | Dietary Supplement: Mixed tree nutsSubjects will be given tree nuts (almonds, hazelnuts, pistachios, macadamia nuts, pecans, walnuts, and cashews) and peanuts (at a predetermined amount to consume based on their recommended energy intake), and advised to follow a diabetic diet. |
| Half-Dose Nut | Experimental | Dietary Supplement: Whole wheat and bran muffin, Dietary Supplement: Mixed tree nutsSubjects will be given tree nuts (almonds, hazelnuts, pistachios, macadamia nuts, pecans, walnuts, and cashews) and peanuts as well as the control supplement (wheat bran muffin)(at a predetermined amount to consume based on their recommended energy intake), and advised to follow a diabetic diet. |
| Control | Active comparator | Dietary Supplement: Whole wheat and bran muffinSubjects will be given a control supplement (wheat bran muffin)(at a predetermined amount to consume based on their recommended energy intake), and advised to follow a diabetic diet. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and post menopausal women with type 2 diabetes treated with diet plus oral hypoglycemic agents (sulfonylureas (glyburide), biguanides (metformin), Thiazolidinediones (TZDs) and new secretagogues (Repaglinide)) at a stable dose for at least 3 months prior to starting the study;
- HbA1c of 6.5 to 8.0% as a compromise between those whose levels are acceptable and the level which is currently considered unacceptable.
- Diabetes diagnosed >6 months prior to randomization
- Weight stable within 3% body weight >2 months.
Key exclusion criteria (12 listed)
- Use of acarbose
- Use of Insulin
- Known nut allergies
- Clinically significant gastroparesis
- Use of steroids
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 |
|---|---|---|
| Whole wheat and bran muffin | Dietary supplement | Control, Half-Dose Nut |
| Mixed tree nuts | Dietary supplement | Full-Dose Nut, Half-Dose Nut |
Primary outcome
Markers of glycemic control: Fasting serum fructosamine
Time frame: From prestudy and week 0, to end of treatment weeks 8, 10, 12
Fasting serum HbA1c
Time frame: From prestudy and week 0, to end of treatment weeks 8, 10, and 12
Fasting glucose
Time frame: From prestudy and week 0, to end of treatment and weeks 8, 10, and 12
Fasting insulin
Time frame: From prestudy and week 0, to end of treatment and weeks 8, 10, and 12
13 secondary outcomes
24h urinary C-peptide excretion
Time frame: From prestudy and week 0, to end of treatment weeks 8, 10, and 12
Branched chain amino acids
Time frame: From prestudy and week 0, to end of treatment weeks 8, 10, and 12
Serum triglyceride
Time frame: From prestudy and week 0, to end of treatment weeks 8, 10, and 12
Very Low-Density Lipoprotein (VLDL) triglyceride
Time frame: From prestudy and week 0, to end of treatment weeks 8, 10, and 12
VLDL-C
Time frame: From prestudy and week 0, to end of treatment weeks 8, 10, and 12
LDL:HDL-C
Time frame: From prestudy and week 0, to end of treatment weeks 8, 10, and 12
Apolipoprotein B:A1
Time frame: From prestudy and week 0, to end of treatment weeks 8, 10, and 12
Lipoprotein(a)
Time frame: From prestudy and week 0, to end of treatment weeks 8, 10, and 12
oxidized LDL
Time frame: From beginning of study, week 0, to end of treatment week 12
markers of oxidative stress
Time frame: From beginning of study, week 0, to end of treatment week 12
C-reactive protein
Time frame: From prestudy and week 0, to end of treatment weeks 8, 10, and 12
markers of inflammation
Time frame: From prestudy and week 0, to end of treatment weeks 8, 10, and 12
Cancer cell proliferation
Time frame: From beginning of study, week 0, to end of treatment week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2013.
- Derived from this study: PubMed 29789878Jenkins DJA, Kendall CWC, Lamarche B, Banach MS, Srichaikul K, Vidgen E, Mitchell S, Parker T, Nishi S, Bashyam B, de Souza RJ, Ireland C, Pichika SC, Beyene J, Sievenpiper JL, Josse RG. Nuts as a replacement for carbohydrates in the diabetic diet: a reanalysis of a randomised controlled trial. Diabetologia. 2018 Aug;61(8):1734-1747. doi: 10.1007/s00125-018-4628-9. Epub 2018 May 23.
- Derived from this study: PubMed 24925120Nishi SK, Kendall CW, Bazinet RP, Bashyam B, Ireland CA, Augustin LS, Blanco Mejia S, Sievenpiper JL, Jenkins DJ. Nut consumption, serum fatty acid profile and estimated coronary heart disease risk in type 2 diabetes. Nutr Metab Cardiovasc Dis. 2014 Aug;24(8):845-52. doi: 10.1016/j.numecd.2014.04.001. Epub 2014 May 13.
- Derived from this study: PubMed 21715526Jenkins DJ, Kendall CW, Banach MS, Srichaikul K, Vidgen E, Mitchell S, Parker T, Nishi S, Bashyam B, de Souza R, Ireland C, Josse RG. Nuts as a replacement for carbohydrates in the diabetic diet. Diabetes Care. 2011 Aug;34(8):1706-11. doi: 10.2337/dc11-0338. Epub 2011 Jun 29.
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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.
David JA Jenkins, MD, PhD principal investigator
University of Toronto, St. Michael's Hospital
Cyril WC Kendall, PhD study chair
University of Toronto, St. Michael's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Whole wheat and bran muffin and Mixed tree nuts in people with Type 2 Diabetes and Cardiovascular Disease, run by University of Toronto at 1 site in Canada.
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 4 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 9 Jan 2013. 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 Canada. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Markers of glycemic control: Fasting serum fructosamine (time frame: From prestudy and week 0, to end of treatment weeks 8, 10, 12). The study lists 4 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 NCT00410722, which also lists 3 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 9 Jan 2013.