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Nuts
Nuts vs. Wheat Bran Muffin for Type 2 Diabetes
Phase 2
Waitlist Available
Led By David JA Jenkins, MD, PhD
Research Sponsored by University of Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Clinically significant gastroparesis
Presence of GI disease (celiac disease, ulcerative colitis, and Crohns)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Summary
This trial will test whether adding tree nuts to the diet improves blood sugar control and other heart disease risk factors in people with type 2 diabetes.
Who is the study for?
This trial is for men and postmenopausal women with type 2 diabetes, treated with certain oral medications, who have been stable in weight and medication dose. They should have had diabetes for over 6 months and an HbA1c level between 6.5 to 8.0%. People with nut allergies, gastrointestinal diseases, recent major cardiovascular events or surgeries, significant liver disease or renal failure cannot participate.
What is being tested?
The study aims to see if mixed tree nuts can improve blood sugar control and heart health in people with type 2 diabetes compared to a whole wheat bran muffin. It will measure changes in HbA1c levels, serum fructosamine, plasma lipids and other markers related to oxidative stress and inflammation.
What are the potential side effects?
Potential side effects may include digestive issues due to high fiber content from the nuts or muffins. For those allergic (excluded from this trial), nuts could cause severe reactions. Otherwise, no significant side effects are expected from these dietary interventions.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a diagnosed condition where my stomach empties too slowly.
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I have a gastrointestinal condition like celiac, ulcerative colitis, or Crohn's.
Select...
I do not have severe liver problems like cirrhosis or hepatitis with high AST or ALT.
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My kidney function is normal, not failing.
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I use insulin for my diabetes.
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I am currently taking acarbose.
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I have had a stroke or heart attack.
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I am currently taking steroids.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Half-Dose NutExperimental Treatment2 Interventions
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.
Group II: Full-Dose NutExperimental Treatment1 Intervention
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.
Group III: ControlActive Control1 Intervention
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.
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Who is running the clinical trial?
University of TorontoLead Sponsor
705 Previous Clinical Trials
1,021,461 Total Patients Enrolled
6 Trials studying Diet Therapy
221 Patients Enrolled for Diet Therapy
David JA Jenkins, MD, PhDPrincipal InvestigatorUniversity of Toronto, St. Michael's Hospital
2 Previous Clinical Trials
237 Total Patients Enrolled
1 Trials studying Diet Therapy
27 Patients Enrolled for Diet Therapy
Cyril WC Kendall, PhDStudy ChairUniversity of Toronto, St. Michael's Hospital
8 Previous Clinical Trials
243 Total Patients Enrolled
1 Trials studying Diet Therapy
27 Patients Enrolled for Diet Therapy
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a man or postmenopausal woman with type 2 diabetes, treated with specific oral medications for at least 3 months.I have a diagnosed condition where my stomach empties too slowly.I have a gastrointestinal condition like celiac, ulcerative colitis, or Crohn's.I am being treated for cancer, not including non-melanoma skin cancer, and my treatment is ongoing or successful.Your weight has not changed by more than 3% in the past 2 months.I have not had major surgery in the last 6 months.I was diagnosed with diabetes more than 6 months ago.I do not have severe liver problems like cirrhosis or hepatitis with high AST or ALT.My kidney function is normal, not failing.Your HbA1c level is between 6.5% and 8.0%.I use insulin for my diabetes.I am currently taking acarbose.You have a known allergy to nuts.Your blood triglyceride level is higher than 6 mmol/L.I have had a stroke or heart attack.I am currently taking steroids.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Full-Dose Nut
- Group 3: Half-Dose Nut
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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