Low Glycemic Index Diet (With Canola Oil) for Type 2 Diabetics

NCT01348568 | Completed Phase 2 DMC

• 1 other identifier: 09-191
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

Brief Summary

Healthy individuals with type 2 diabetes will receive intensive counseling on food selection to improve glucose control using either high cereal fiber dietary strategies or low glycemic index foods especially canola oil containing bread. The treatments will last 3 months with bloods taken for HbA1c, glucose and blood lipids. If the study shows a benefit for either or both diets, then use of high fiber, and/or low glycemic index foods with canola oil, may provide another potential way to improve glucose control and lower cholesterol levels in non-insulin dependent diabetes.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

• Change in HbA1c

  from prestudy and week 0, to end of treatment weeks 8, 10, and 12

• change in serum lipids

  from prestudy and week 0, to end of treatment weeks 8, 10, and 12

Secondary Outcomes (6)

• fasting glucose

  from prestudy and week 0, to end of treatment weeks 8, 10, and 12

• change in weight, waist, and hip circumference

  weeks 0 to 12

• change in blood pressure

  from prestudy and week 0, to end of treatment weeks 8, 10, and 12

• creatinine, urea, and c-peptides in 24 hour urine collection

  0, 12 weeks

• endothelial function

  week 0, 12

Study Arms (2)

Low glycemic index diet with canola oil bread

EXPERIMENTAL

Subjects will be given whole wheat bread which includes canola oil, and advised to follow a diabetic diet using low glycemic index foods.

Dietary Supplement: low glycemic index diet with canola oil bread

high fiber diet

ACTIVE COMPARATOR

Subjects will be given whole wheat bread, and advised to follow a healthy high fiber diabetic diet.

Dietary Supplement: High fiber diet

Interventions

low glycemic index diet with canola oil bread DIETARY_SUPPLEMENT

Low glycemic index diet with canola oil bread

High fiber diet DIETARY_SUPPLEMENT

high fiber diet

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women with type 2 diabetes who
• are treated with oral hypoglycemic agents at a stable dose for at least 8 weeks
• have a HbA1c in the range of 6.5 to 8.5% at the initial screening visit and at the prestudy visit (visit just prior to randomization)
• have diabetes diagnosed \>6 months
• have maintained stable weight for 2 months (within 3%)
• have a valid OHIP card and a family physician
• if prescribed lipid medication, have taken a stable dose for at least 2 weeks
• if prescribed blood pressure medication, have taken a stable dose for at least 1 week
• can keep written food records, with the use of a digital scale

You may not qualify if:

• take insulin
• take steroids
• have GI disease (gastroparesis, celiac disease, ulcerative colitis, Crohn's Disease, IBS)
• have had a major cardiovascular event (stroke or myocardial infarction) in the past 6 months
• take warfarin (Coumadin)
• have had major surgery in the past 6 months
• have a major debilitating disorder
• have clinically significant liver disease (AST or ALT \> 130 U/L), excluding NAFL or NASH
• have hepatitis B or C
• have renal failure (high creatinine \> 150 mmol/L)
• have serum triglycerides ≥ 6.0 mmol/L
• have a history of cancer, except non-melanoma skin cancer (basal cell, squamous cell)
• have food allergies to canola oil, study food components
• have elevated blood pressure (\> 145/90) unless approved by General Practitioner (GP)
• have acute or chronic infections (bacterial or viral)

Sponsors & Collaborators

• University of Toronto: lead
• Canola Council of Canada: collaborator

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5C2T2, Canada

Location

Related Publications (1)

• Jenkins DJ, Kendall CW, Vuksan V, Faulkner D, Augustin LS, Mitchell S, Ireland C, Srichaikul K, Mirrahimi A, Chiavaroli L, Blanco Mejia S, Nishi S, Sahye-Pudaruth S, Patel D, Bashyam B, Vidgen E, de Souza RJ, Sievenpiper JL, Coveney J, Josse RG, Leiter LA. Effect of lowering the glycemic load with canola oil on glycemic control and cardiovascular risk factors: a randomized controlled trial. Diabetes Care. 2014 Jul;37(7):1806-14. doi: 10.2337/dc13-2990. Epub 2014 Jun 14.

  PMID: 24929428 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• David J A Jenkins, MD, DSc

  Dept of Nutritional Science, University of Toronto, Toronto, ON, Canada

  PRINCIPAL INVESTIGATOR

• Cyril W C Kendall, PhD

  Dept of Nutritional Science, University of Toronto, Toronto, Canada

  PRINCIPAL INVESTIGATOR

• Robert Josse, MD

  Dept of Medicine, Div of Endocrinology and Metabolism, St. Michael's, Toronto, ON, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: May 4, 2011
• First Posted: May 5, 2011
• Study Start: March 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: March 1, 2015
• Last Updated: December 8, 2015

Record last verified: 2015-12

Locations

CA (1)