Type 2 DiabetesNCT00438698
Low Glycemic Index Diets vs. High Cereal Fibre Diets in Type 2 Diabetes
A study testing Low Glycemic Index diet and High Cereal Fibre Diets in people with Type 2 Diabetes and Cardiovascular Disease, run by University of Toronto at 1 site in Canada.
Trial summary
Large observational studies have shown cereal fiber to protect from diabetes and heart disease. Despite the success of acarbose, an α-glucosidase hydrolase inhibitor, which lowers the glycemic index of foods containing starch, sucrose and maltodextrins, the use of diets containing low glycemic index foods still… Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Type 2 Diabetes, Cardiovascular Disease
- What is being tested?
- Low Glycemic Index diet and High Cereal Fibre Diets
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2004to Jun 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and postmenopausal women with type 2 diabetes treated with diet plus oral hypoglycemic agents (Sulfonylureas, Biguanides, Thiazolidinediones , and new secretagogues (Repaglinide)) at a stable dose for at least 3 months prior to starting the study
- 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
Who cannot join
- diabetic complications: clinically significant gastroparesis, retinopathy, nephropathy, neuropathy, hepatic disease, or CHD (current clinically significant CHD e.g. unstable angina)
- taking insulin or acarbose
- smoking or significant alcohol intake (> 1 drink/day)
- serum triglycerides > 4.0 mmol/L
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Low Glycemic Index Diets on Glucose Control in Non-Insulin Dependent Diabetics
Large observational studies have shown cereal fiber to protect from diabetes and heart disease. Despite the success of acarbose, an α-glucosidase hydrolase inhibitor, which lowers the glycemic index of foods containing starch, sucrose and maltodextrins, the use of diets containing low glycemic index foods still remains to be established. We will therefore provide otherwise healthy individuals with type 2 diabetes intensive counseling on food selection either to improve glucose control using high cereal fiber dietary strategies or low glycemic index foods. Studies will last 6 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 in the diet may provide another potential way to improve glucose control and lower cholesterol levels in non-insulin dependent diabetes.
Read the detailed description
Recruitment: Subjects will be recruited by placing advertisements in local newspapers and by distributing similar advertisements to the diabetes clinic and diabetes education programs.
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
- Type 2 Diabetes, Cardiovascular Disease
- Being tested
- Low Glycemic Index diet, High Cereal Fibre Diets
- Keywords
- Nutrition, Type 2 Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Glycemic Index dietOther
Diet to emphasize carbohydrate foods low in glycemic index
High Cereal Fibre DietsOther
Diet to emphasize whole wheat carbohydrate cgoices
| Study group | Role | What they receive |
|---|---|---|
| Low Glycemic Index Diet | Experimental | Diet with low glycemic index carbohydrates Receives: Other: Low Glycemic Index diet |
| High Fiber Diet | Active comparator | Diet with high cereal fibre choices Receives: Other: High Cereal Fibre Diets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin A1c
Measured: 6 months
Change in Fasting Glucose
Measured: 6 months
Secondary outcomes (14)
serum FFA
Measured: 6 months
C-peptide
Measured: 6 months
CRP
Measured: 6 months
IGF-I
Measured: 6 months
IGFBP-3
Measured: 6 months
Serum apo AI
Measured: 6 months
apo B
Measured: 6 months
apo Lp(a)
Measured: 6 months
amino acids
Measured: 6 months
Plasma lipids and lipoproteins (TG, LDL, HDL)
Measured: 6 months
Oxidized LDL
Measured: 6 months
Change in Urinary creatinine
Measured: 6 months
urea
Measured: 6 months
Urinary C-peptide
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2007 (estimated)
- Study startSep 2004
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Jenkins, University of Toronto
- Investigators
- David JA Jenkins, MD, PhD, Principal investigator, University of Toronto, St. Michael's HospitalCyril WC Kendall, PhD, Study director, University of Toronto, St. Michael's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00438698
- Sponsor's protocol ID
- REB 04-021
- Other IDs
- CIHR RCT#: 67894
- Status last verified
- Dec 2015
- First submitted
- 21 Feb 2007
- Last updated
- 16 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 39275135Ha 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.
PubMed 28958804Jenkins 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.
PubMed 20978741Jenkins 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.
PubMed 19088352
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low Glycemic Index Diets on Glucose Control in Non-Insulin Dependent Diabetics
- ClinicalTrials.gov ID
- NCT00438698
- Acronym / sponsor ID
- REB 04-021
- Conditions
- Type 2 Diabetes, Cardiovascular Disease
- Keywords
- Nutrition, Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- Sep 2004
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 22 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Large observational studies have shown cereal fiber to protect from diabetes and heart disease. Despite the success of acarbose, an α-glucosidase hydrolase inhibitor, which lowers the glycemic index of foods containing starch, sucrose and maltodextrins, the use of diets containing low glycemic index foods still remains to be established. We will therefore provide otherwise healthy individuals with type 2 diabetes intensive counseling on food selection either to improve glucose control using high cereal fiber dietary strategies or low glycemic index foods. Studies will last 6 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 in the diet may provide another potential way to improve glucose control and lower cholesterol levels in non-insulin dependent diabetes.
Detailed description
Recruitment: Subjects will be recruited by placing advertisements in local newspapers and by distributing similar advertisements to the diabetes clinic and diabetes education programs.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Glycemic Index Diet | Experimental | Other: Low Glycemic Index dietDiet with low glycemic index carbohydrates |
| High Fiber Diet | Active comparator | Other: High Cereal Fibre DietsDiet with high cereal fibre choices |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and postmenopausal women with type 2 diabetes treated with diet plus oral hypoglycemic agents (Sulfonylureas, Biguanides, Thiazolidinediones , and new secretagogues (Repaglinide)) at a stable dose for at least 3 months prior to starting the study
- 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
Key exclusion criteria (4 listed)
- diabetic complications: clinically significant gastroparesis, retinopathy, nephropathy, neuropathy, hepatic disease, or CHD (current clinically significant CHD e.g. unstable angina)
- taking insulin or acarbose
- smoking or significant alcohol intake (> 1 drink/day)
- serum triglycerides > 4.0 mmol/L
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Glycemic Index dietDiet to emphasize carbohydrate foods low in glycemic index | Other | Low Glycemic Index Diet |
| High Cereal Fibre DietsDiet to emphasize whole wheat carbohydrate cgoices | Other | High Fiber Diet |
Primary outcome
Change in Hemoglobin A1c
Time frame: 6 months
Change in Fasting Glucose
Time frame: 6 months
14 secondary outcomes
serum FFA
Time frame: 6 months
C-peptide
Time frame: 6 months
CRP
Time frame: 6 months
IGF-I
Time frame: 6 months
IGFBP-3
Time frame: 6 months
Serum apo AI
Time frame: 6 months
apo B
Time frame: 6 months
apo Lp(a)
Time frame: 6 months
amino acids
Time frame: 6 months
Plasma lipids and lipoproteins (TG, LDL, HDL)
Time frame: 6 months
Oxidized LDL
Time frame: 6 months
Change in Urinary creatinine
Time frame: 6 months
urea
Time frame: 6 months
Urinary C-peptide
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2015.
- Derived from this study: PubMed 39275135Kavanagh 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.
- Derived from this study: PubMed 28958804Ha 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.
- Derived from this study: PubMed 20978741Jenkins 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.
- Derived from this study: PubMed 19088352Jenkins 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David JA Jenkins, MD, PhD principal investigator
University of Toronto, St. Michael's Hospital
Cyril WC Kendall, PhD study director
University of Toronto, St. Michael's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Glycemic Index diet and High Cereal Fibre Diets in people with Type 2 Diabetes and Cardiovascular Disease, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hemoglobin A1c (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00438698, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2015.