Low Glycemic Index Diets vs. High Cereal Fibre Diets in Type 2 Diabetes
NCT ID: NCT00438698
Last Updated: 2015-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
210 participants
INTERVENTIONAL
2004-09-30
2007-06-30
Brief Summary
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Detailed Description
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Information Sessions: Approximately 1000 volunteers in groups of 10-30 with or without spouses will attend one of a number of evening information sessions run from the Risk Factor Modification Center at St. Michael's Hospital. During the sessions the exact nature of the study will be described and volunteers will have the opportunity to ask specific questions about the study and taste the high fiber and low glycemic index foods.
Screening: Potential subjects will then fill in and return to the investigators a detailed questionnaire concerning their medical history, medications (including vitamin, mineral and nutritional supplements) smoking habits, alcohol intake and exercise pattern and whether they are currently on a specific diet. Details will also be obtained concerning planned vacations. Those subjects deemed potentially eligible will be asked to give a fasting blood sample at the Risk Factor Modification Center. Individuals who meet the study criteria, are invited to return again to the Center. The principles of the diabetic diet which they are already expected to be following will be reinforced, which incorporate the key elements of an NCEP Step 2 diet (total calories from fat \<30%, saturated fat \<7%, polyunsaturated fat \<10%, dietary cholesterol \<200 mg/day).
All subjects will then be randomized to one 24-week treatment in a two-treatment parallel design.
Treatments: 1) low glycemic index dietary advice (e.g. to eat intact grain cereals, pumpernickel bread, parboiled rice, cracked wheat, pasta, peas, beans and lentils) 2) high cereal fiber diet. Background diets will be the subjects' diabetic diets, modified as above, which will conform to CDA and NCEP Step 2 guidelines. Diet histories will be recorded at weeks 0, 2, 4, 8, 12, 16 and 24. These diets will be assessed for consistency by the dietitian in the subject's presence. Where necessary, modifications in diet will be made to ensure weight maintenance. Compliance will be assessed by 7 day food records.
Duration: the study will consist of four months recruitment and patient selection, during which time estimation of individual caloric requirements will be performed, and 6 months treatment period
Study Details: Fasting blood samples are obtained at day zero and weeks 2, 4, 8, 12, 16 and 24 of each study period. Twenty-four hour urine for urinary C-peptide analyses will be obtained immediately prior to the beginning of the study and at the end of each 24-week treatment phase.
Palatability and satiety: subjects will record their ratings using a 9-point bipolar semantic scale at weekly intervals during each study phase.
Anthropometric measures: height at recruitment, waist and hip circumference, and body composition will be taken immediately prior to and at the end of each study phase. Body weight and blood pressure will be measured at clinic visits.
This study will help to indicate whether dietary advice can make a significant difference to glycemic control as has been the case with drug therapy to reduce postprandial glycemia.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Low Glycemic Index Diet
Diet with low glycemic index carbohydrates
Low Glycemic Index diet
Diet to emphasize carbohydrate foods low in glycemic index
High Fiber Diet
Diet with high cereal fibre choices
High Cereal Fibre Diets
Diet to emphasize whole wheat carbohydrate cgoices
Interventions
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Low Glycemic Index diet
Diet to emphasize carbohydrate foods low in glycemic index
High Cereal Fibre Diets
Diet to emphasize whole wheat carbohydrate cgoices
Eligibility Criteria
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Inclusion Criteria
* HbA1c between 6.5 and 8.0% at recruitment
* living within a 40 km radius of St. Michael's Hospital
* Diabetes diagnosed \> 6 months prior to randomization
Exclusion Criteria
* taking insulin or acarbose
* smoking or significant alcohol intake (\> 1 drink/day)
* serum triglycerides \> 4.0 mmol/L
21 Years
100 Years
ALL
No
Sponsors
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University of Toronto
OTHER
Responsible Party
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David Jenkins
Professor
Principal Investigators
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David JA Jenkins, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Toronto, St. Michael's Hospital
Cyril WC Kendall, PhD
Role: STUDY_DIRECTOR
University of Toronto, St. Michael's Hospital
Locations
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St. Michael's Hospital
Toronto, Ontario, Canada
Countries
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References
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Kavanagh ME, Back S, Chen V, Glenn AJ, Viscardi G, Houshialsadat Z, Sievenpiper JL, Kendall CWC, Jenkins DJA, Chiavaroli L. The Portfolio Diet and HbA1c in Adults Living with Type 2 Diabetes Mellitus: A Patient-Level Pooled Analysis of Two Randomized Dietary Trials. Nutrients. 2024 Aug 23;16(17):2817. doi: 10.3390/nu16172817.
Ha V, Viguiliouk E, Kendall CWC, Balachandran B, Jenkins DJA, Kavsak PA, Sievenpiper JL. Effect of a low glycemic index diet versus a high-cereal fibre diet on markers of subclinical cardiac injury in healthy individuals with type 2 diabetes mellitus: An exploratory analysis of a randomized dietary trial. Clin Biochem. 2017 Dec;50(18):1104-1109. doi: 10.1016/j.clinbiochem.2017.09.021. Epub 2017 Sep 25.
Jenkins DJ, Srichaikul K, Kendall CW, Sievenpiper JL, Abdulnour S, Mirrahimi A, Meneses C, Nishi S, He X, Lee S, So YT, Esfahani A, Mitchell S, Parker TL, Vidgen E, Josse RG, Leiter LA. The relation of low glycaemic index fruit consumption to glycaemic control and risk factors for coronary heart disease in type 2 diabetes. Diabetologia. 2011 Feb;54(2):271-9. doi: 10.1007/s00125-010-1927-1. Epub 2010 Oct 27.
Jenkins DJ, Kendall CW, McKeown-Eyssen G, Josse RG, Silverberg J, Booth GL, Vidgen E, Josse AR, Nguyen TH, Corrigan S, Banach MS, Ares S, Mitchell S, Emam A, Augustin LS, Parker TL, Leiter LA. Effect of a low-glycemic index or a high-cereal fiber diet on type 2 diabetes: a randomized trial. JAMA. 2008 Dec 17;300(23):2742-53. doi: 10.1001/jama.2008.808.
Other Identifiers
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CIHR RCT#: 67894
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
REB 04-021
Identifier Type: -
Identifier Source: org_study_id