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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
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
Diabetes diagnosed >6 months prior to randomization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from prestudy and week 0, to end of treatment weeks 8, 10, 12
Awards & highlights
Study 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.Check my eligibility
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.See study design
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
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a man or postmenopausal woman with type 2 diabetes, treated with specific oral medications for at least 3 months.
Select...
I was diagnosed with diabetes more than 6 months ago.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from prestudy and week 0, to end of treatment weeks 8, 10, 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from prestudy and week 0, to end of treatment weeks 8, 10, 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Fasting glucose
Fasting insulin
Fasting serum HbA1c
+1 moreSecondary outcome measures
24h urinary C-peptide excretion
Apolipoprotein B:A1
Branched chain amino acids
+10 moreTrial 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.
Find a Location
Who is running the clinical trial?
University of TorontoLead Sponsor
689 Previous Clinical Trials
1,018,553 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How does Whole wheat and bran muffin consumption impact patients?
"There is some data supporting the safety of eating whole wheat and bran muffins, but none to support its efficacy. It received a score of 2."
Answered by AI
Are we still enrolling people in this experiment?
"Based on the information available through clinicaltrials.gov, it seems that this study is not currently looking for more candidates. Although the trial is no longer active, there are 1916 other trials which patients may be able to participate in."
Answered by AI
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