Effect of Nuts vs. a Wheat Bran Muffin in Type 2 Diabetes
Type 2 Diabetes, Cardiovascular Disease, Diet Therapy
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring Nutrition, Type 2 Diabetes
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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)
- 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.
Sites / Locations
- St. Michael's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Active Comparator
Full-Dose Nut
Half-Dose Nut
Control
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.
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.
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.