Type 2 DiabetesNCT02245399
Canola-Mediterranean Diet Study in T2DM
A study testing A canola oil enriched mediterranean diet and A high wheat fiber diet in people with Type 2 Diabetes and Obesity, run by Unity Health Toronto at 3 sites in Canada.
Trial summary
The purpose of the study is to assess whether a Mediterranean-type weight-loss diet, enriched with canola oil, high in plant protein, and low in carbohydrates will produce blood sugar control, reduce coronary heart disease (CHD) risk factors and maximize weight loss, better than conventional higher carbohydrate diets… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Type 2 Diabetes, Obesity, Overweight
- What is being tested?
- A canola oil enriched mediterranean diet and A high wheat fiber diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 3 sitesCanada
- Study dates
- Oct 2014to 13 Mar 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women with type 2 diabetes diagnosed for more than 6 months
- BMI >27 (non-Asians); BMI >25 (Asians)
- HbA1c between 6.5% and 8.5% at screening, and at the preparation visit before starting diet
- on a stable prescribed dose of oral diabetes medication for at least 2 months
- on a stable dose of lipid medication for at least 2 weeks, if prescribed
- on a stable dose of blood pressure medication for at least 1 week, if prescribed
- have a family physician
- can keep written food records, with the use of a digital scale
Who cannot join
- Individuals with the following characteristics/conditions will be excluded
- on insulin
- on steroids
- on warfarin (Coumadin)
- GI disease (gastroparesis, celiac, colitis, Crohn's disease, Inflammatory Bowel Syndrome)
- history of cancer, except non-melanoma skin cancer (basal cell, squamous cell)
Show all 19Show fewer
- major cardiovascular event (stroke, myocardial infarction) in past 6 months
- major surgery in past 6 months
- major debilitating disorder
- liver disease (AST or ALT> 3x the upper limit of normal) except non-alcoholic fatty liver (NAFL) disease or non-alcoholic steatohepatitis (NASH).
- hepatitis B or C
- renal failure (creatinine > 150 mmol/L)
- serum triglycerides >4.5mmol/L
- acute or chronic infections (bacterial or viral)
- chronic inflammatory diseases (e.g. lupus, ulcerative colitis)
- blood pressure >145/90, unless approved by their family physician
- alcohol consumption >2 drinks/d
- food allergies to wheat, canola, or other study food components
- any condition determined by the investigators to make the subject unsuitable for the study
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Institute of Nutraceuticals and Functional Foods, Laval University
Québec, Quebec, G1V 4G2
Risk Factor Modification Centre, St. Michael's Hospital
Toronto, Ontario, M5C 2T2
Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba
Winnipeg, Manitoba, R3T 6C5
About this study
Official title: Canola Enriched Mediterranean Type Weight Loss Diet in Type 2 Diabetes
The purpose of the study is to assess whether a Mediterranean-type weight-loss diet, enriched with canola oil, high in plant protein, and low in carbohydrates will produce blood sugar control, reduce coronary heart disease (CHD) risk factors and maximize weight loss, better than conventional higher carbohydrate diets in overweight diabetic patients.
Read the detailed description
The investigators plan to assess the effects of increasing both canola oil and plant protein foods while reducing carbohydrate intake in the context of a Mediterranean type diet on weight loss, glycemic control and cardiovascular risk factors in type 2 diabetes.
Obesity rates in Western nations have shown a dramatic rise in the last 20 years and diabetes rates have doubled, a trend which is predicted to be repeated over the next 20 years. In Canada the predicted cost to the healthcare system in only 7 years will rise to $17 billion. Weight loss diets (such as Atkins, Eddies, South Beach and Zone) emphasizing carbohydrate restriction have become increasingly popular for the prevention and treatment of diabetes. As a result, lower carbohydrate diets are being selected by health conscious members of the general population including those with diabetes. Because such diets in effect promote a high intake of protein from animal sources, even in the presence of weight loss, serum cholesterol levels rise due to increased cholesterol and saturated fat intake; and a further rise in serum lipids is likely to occur in the long term when weight loss has ceased. On the other hand, lower carbohydrate dietary patterns that are higher in plant rather than animal fat and proteins have been associated with improved blood lipids and reduced risk of heart disease and type 2 diabetes.
The investigators have therefore planned a study in which a weight reducing low carbohydrate, Mediterranean type diet that is high in plant proteins and canola oil will be compared to a weight reducing high cereal fibre diet in a 3 month study. 150 overweight and obese participants with type 2 diabetes will be randomized to one of 2 treatments.
Study visits will be as follows: weeks -2, 0 (for randomization), 2, 4, 8, 10 and 12. Body measurements, blood pressure and blood samples will be taken at each visit except week 2. The week 2 visit will be mainly for reinforcement of dietary advice; also body weight will be measured and blood drawn for fast glucose and HbA1c. Diet records will be reviewed at all visits. 24 hour urine samples will be collected at week 0 and week 12.
On completion of the 12 week study, participants will be given the option of continuing on the same diet or trying the opposite diet for a further 12 weeks. Visits will be every 4 weeks for a total of 3 visit. Body measurements, blood pressure and blood samples will be taken during these visits as in the initial 12 week study.
- Conditions
- Type 2 Diabetes, Obesity, Overweight, Cardiovascular Diseases
- Being tested
- A canola oil enriched mediterranean diet, A high wheat fiber diet
- Keywords
- Weight loss, Diabetes, Cardiovascular disease (CVD) risk, Weight loss diet, mediterranean type diet, Canola oil, Low-carbohydrate diet, Glycemic index
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Overweight, Cardiovascular Diseases, Weight Loss, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A canola oil enriched mediterranean dietBehavioural
Also called A mediterranean weight-reducing diet emphasizing canola oil, Eco-Atkins diet, Low carbohydrate dietary portfolio
The diet will be provided at 60% of calories estimated for stable body weight to encourage weight loss. A high protein canola oil-enriched test bread will be provided as a supplement.
A high wheat fiber dietBehavioural
Also called DASH-type diet
The diet will be provided at 60% of calories estimated for stable body weight to encourage weight loss. A whole wheat control bread will be provided as a supplement to participants
| Study group | Role | What they receive |
|---|---|---|
| A canola oil enriched mediterranean diet | Experimental | Participants will be advised to consume, a low-carbohydrate diet (26-32% of calories), high in vegetable protein (28-32%) and fat (41-45%) with canola as the major component (10%). Carbohydrate sources will feature viscous fiber-containing foods (including psyllium cereal, oats and barley) and low-starch vegetables (emphasizing okra and eggplant) for the relatively limited amount of carbohydrate. Receives: Behavioral: A canola oil enriched mediterranean diet |
| A high wheat fiber diet | Active comparator | Participant will be advised to consume a high carbohydrate diet (58% carbohydrate, 16% protein and 25% fat) emphasizing whole wheat/whole grain cereals and increased high fiber alternatives, with fruits and vegetables. Receives: Behavioral: A high wheat fiber diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in HbA1c
The baseline HbA1c will be the average HbA1c of weeks -2 and week 0. The end HbA1c will be the average HbA1c of weeks 8, 10 and 12. Change will be the difference between the end and baseline values
Measured: Measured at weeks -2, 0, and then at weeks 8, 10 and 12
Secondary outcomes (10)
Change in body weight
Measured: baseline (week 0) and end (week 12)
blood glucose
Measured: At weeks 0, 2, 4, 8, 10 and 12
Serum lipids: total cholesterol, LDL-chol, HDL-chol and Triglycerides
Measured: At weeks 0, 4, 8, 10 and 12
Blood pressure
Measured: At weeks 0, 4, 8, 10 and 12
24-hour Ambulatory blood pressure profile
Measurement will be done using a non-invasive SpaceLabs 90217 Ambulatory BP monitor
Measured: At weeks -1 and 12
diet history
7-day food records brought in at weeks 0, 2, 4, 8, 10 and 12 will be analyzed for macro and micro nutrient intakes.
Measured: At weeks 0, 2, 4, 8, 10 and 12
C-reactive protein
Measured: At weeks 0 and 12
Cholesterol absorption
This is an optional sub-study that will be carried out prior to the first and last weeks of the 12 week study. On day 1 (a Monday) of the week -1 and last weeks of the study after an overnight 12hr fast, blood will be drawn and participants will be asked to ingest 75mg of the stable carbon isotope [3, 4-13C] cholesterol dissolved in 5g of margarine and spread on half of an English muffin. Subsequent blood draws will be taken after an overnight 12hr fast, at 48 h (a Wednesday) and 72 h (a Thursday) after ingestion of the labeled cholesterol.
Measured: At weeks -1 and 12
change in LDL particle size
LDL particle size at weeks 0 and 12 will be determined by assessing their electrophoretic characteristics obtained by non-denaturing polyacrylamide gradient (2-16%) gel electrophoresis of serum
Measured: Weeks 0 and 12
urinary analyses
24 hr urine samples will be analyzed for creatinine, urea, C-peptide, minerals, electrolytes and other dietary biomarkers
Measured: week 0 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study startOct 2014
- Primary completion14 Dec 2016
- Study completion13 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- 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
- Investigator
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto, Laval University, University of Manitoba, Canola Council of Canada
- Responsible party
- Sponsor
- Investigators
- David J Jenkins, MD, Principal investigator, St. Michael's Hospital / University of TorontoCyril Kendall, PhD, Study director, University of TorontoVladimir Vuksan, PhD, Study director, Unity Health TorontoPeter Jones, PhD, Study director, University of ManitobaBenoit Lamarche, PhD, Study director, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02245399
- Sponsor's protocol ID
- REB# 14-086
- Other IDs
- CFC/Fund 200134/496744
- Status last verified
- Sep 2018
- First submitted
- 5 Sep 2014
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Alhassan S, Kim S, Bersamin A, King AC, Gardner CD. Dietary adherence and weight loss success among overweight women: results from the A TO Z weight loss study. Int J Obes (Lond). 2008 Jun;32(6):985-91. doi: 10.1038/ijo.2008.8. Epub 2008 Feb 12.
PubMed 18268511Anderson JW, Randles KM, Kendall CW, Jenkins DJ. Carbohydrate and fiber recommendations for individuals with diabetes: a quantitative assessment and meta-analysis of the evidence. J Am Coll Nutr. 2004 Feb;23(1):5-17. doi: 10.1080/07315724.2004.10719338.
PubMed 14963049Shai I, Schwarzfuchs D, Henkin Y, Shahar DR, Witkow S, Greenberg I, Golan R, Fraser D, Bolotin A, Vardi H, Tangi-Rozental O, Zuk-Ramot R, Sarusi B, Brickner D, Schwartz Z, Sheiner E, Marko R, Katorza E, Thiery J, Fiedler GM, Bluher M, Stumvoll M, Stampfer MJ; Dietary Intervention Randomized Controlled Trial (DIRECT) Group. Weight loss with a low-carbohydrate, Mediterranean, or low-fat diet. N Engl J Med. 2008 Jul 17;359(3):229-41. doi: 10.1056/NEJMoa0708681.
PubMed 18635428Jenkins DJ, Wong JM, Kendall CW, Esfahani A, Ng VW, Leong TC, Faulkner DA, Vidgen E, Greaves KA, Paul G, Singer W. The effect of a plant-based low-carbohydrate ("Eco-Atkins") diet on body weight and blood lipid concentrations in hyperlipidemic subjects. Arch Intern Med. 2009 Jun 8;169(11):1046-54. doi: 10.1001/archinternmed.2009.115.
PubMed 19506174Guariguata L, Whiting D, Weil C, Unwin N. The International Diabetes Federation diabetes atlas methodology for estimating global and national prevalence of diabetes in adults. Diabetes Res Clin Pract. 2011 Dec;94(3):322-32. doi: 10.1016/j.diabres.2011.10.040. Epub 2011 Nov 17.
PubMed 22100977Kris-Etherton P, Eckel RH, Howard BV, St Jeor S, Bazzarre TL; Nutrition Committee Population Science Committee and Clinical Science Committee of the American Heart Association. AHA Science Advisory: Lyon Diet Heart Study. Benefits of a Mediterranean-style, National Cholesterol Education Program/American Heart Association Step I Dietary Pattern on Cardiovascular Disease. Circulation. 2001 Apr 3;103(13):1823-5. doi: 10.1161/01.cir.103.13.1823. No abstract available.
PubMed 11282918Sacks FM, Bray GA, Carey VJ, Smith SR, Ryan DH, Anton SD, McManus K, Champagne CM, Bishop LM, Laranjo N, Leboff MS, Rood JC, de Jonge L, Greenway FL, Loria CM, Obarzanek E, Williamson DA. Comparison of weight-loss diets with different compositions of fat, protein, and carbohydrates. N Engl J Med. 2009 Feb 26;360(9):859-73. doi: 10.1056/NEJMoa0804748.
PubMed 19246357Friedewald WT, Levy RI, Fredrickson DS. Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge. Clin Chem. 1972 Jun;18(6):499-502. No abstract available.
PubMed 4337382Jenkins DJ, Wong JM, Kendall CW, Esfahani A, Ng VW, Leong TC, Faulkner DA, Vidgen E, Paul G, Mukherjea R, Krul ES, Singer W. Effect of a 6-month vegan low-carbohydrate ('Eco-Atkins') diet on cardiovascular risk factors and body weight in hyperlipidaemic adults: a randomised controlled trial. BMJ Open. 2014 Feb 5;4(2):e003505. doi: 10.1136/bmjopen-2013-003505.
PubMed 24500611Gremaud G, Piguet C, Baumgartner M, Pouteau E, Decarli B, Berger A, Fay LB. Simultaneous assessment of cholesterol absorption and synthesis in humans using on-line gas chromatography/ combustion and gas chromatography/pyrolysis/isotope-ratio mass spectrometry. Rapid Commun Mass Spectrom. 2001;15(14):1207-13. doi: 10.1002/rcm.365.
PubMed 11445904Jenkins DJ, Jones PJ, Abdullah MM, Lamarche B, Faulkner D, Patel D, Sahye-Pudaruth S, Paquette M, Bashyam B, Pichika SC, Kavanagh ME, Patel P, Liang F, Brown R, Zhao T, Phan M, Mathiyalagan G, Tandon S, Vuksan V, Jovanovski E, Sievenpiper JL, Kendall CW, Leiter LA, Josse RG. Low-carbohydrate vegan diets in diabetes for weight loss and sustainability: a randomized controlled trial. Am J Clin Nutr. 2022 Nov;116(5):1240-1250. doi: 10.1093/ajcn/nqac203. Epub 2023 Feb 10.
PubMed 36156115
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Canola Enriched Mediterranean Type Weight Loss Diet in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02245399
- Acronym / sponsor ID
- REB# 14-086
- Conditions
- Type 2 Diabetes, Obesity, Overweight, Cardiovascular Diseases
- Keywords
- Weight loss, Diabetes, Cardiovascular disease (CVD) risk, Weight loss diet, mediterranean type diet, Canola oil, Low-carbohydrate diet, Glycemic index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- University of Toronto, Laval University, University of Manitoba, Canola Council of Canada
- Study start
- Oct 2014 (actual)
- Primary completion
- 14 Dec 2016 (actual)
- Study completion
- 13 Mar 2017 (actual)
- First posted
- 19 Sep 2014 (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.
The purpose of the study is to assess whether a Mediterranean-type weight-loss diet, enriched with canola oil, high in plant protein, and low in carbohydrates will produce blood sugar control, reduce coronary heart disease (CHD) risk factors and maximize weight loss, better than conventional higher carbohydrate diets in overweight diabetic patients.
Detailed description
The investigators plan to assess the effects of increasing both canola oil and plant protein foods while reducing carbohydrate intake in the context of a Mediterranean type diet on weight loss, glycemic control and cardiovascular risk factors in type 2 diabetes.
Obesity rates in Western nations have shown a dramatic rise in the last 20 years and diabetes rates have doubled, a trend which is predicted to be repeated over the next 20 years. In Canada the predicted cost to the healthcare system in only 7 years will rise to $17 billion. Weight loss diets (such as Atkins, Eddies, South Beach and Zone) emphasizing carbohydrate restriction have become increasingly popular for the prevention and treatment of diabetes. As a result, lower carbohydrate diets are being selected by health conscious members of the general population including those with diabetes. Because such diets in effect promote a high intake of protein from animal sources, even in the presence of weight loss, serum cholesterol levels rise due to increased cholesterol and saturated fat intake; and a further rise in serum lipids is likely to occur in the long term when weight loss has ceased. On the other hand, lower carbohydrate dietary patterns that are higher in plant rather than animal fat and proteins have been associated with improved blood lipids and reduced risk of heart disease and type 2 diabetes.
The investigators have therefore planned a study in which a weight reducing low carbohydrate, Mediterranean type diet that is high in plant proteins and canola oil will be compared to a weight reducing high cereal fibre diet in a 3 month study. 150 overweight and obese participants with type 2 diabetes will be randomized to one of 2 treatments.
Study visits will be as follows: weeks -2, 0 (for randomization), 2, 4, 8, 10 and 12. Body measurements, blood pressure and blood samples will be taken at each visit except week 2. The week 2 visit will be mainly for reinforcement of dietary advice; also body weight will be measured and blood drawn for fast glucose and HbA1c. Diet records will be reviewed at all visits. 24 hour urine samples will be collected at week 0 and week 12.
On completion of the 12 week study, participants will be given the option of continuing on the same diet or trying the opposite diet for a further 12 weeks. Visits will be every 4 weeks for a total of 3 visit. Body measurements, blood pressure and blood samples will be taken during these visits as in the initial 12 week study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A canola oil enriched mediterranean diet | Experimental | Behavioral: A canola oil enriched mediterranean dietParticipants will be advised to consume, a low-carbohydrate diet (26-32% of calories), high in vegetable protein (28-32%) and fat (41-45%) with canola as the major component (10%). Carbohydrate sources will feature viscous fiber-containing foods (including psyllium cereal, oats and barley) and low-starch vegetables (emphasizing okra and eggplant) for the relatively limited amount of carbohydrate. |
| A high wheat fiber diet | Active comparator | Behavioral: A high wheat fiber dietParticipant will be advised to consume a high carbohydrate diet (58% carbohydrate, 16% protein and 25% fat) emphasizing whole wheat/whole grain cereals and increased high fiber alternatives, with fruits and vegetables. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men and women with type 2 diabetes diagnosed for more than 6 months
- BMI >27 (non-Asians); BMI >25 (Asians)
- HbA1c between 6.5% and 8.5% at screening, and at the preparation visit before starting diet
- on a stable prescribed dose of oral diabetes medication for at least 2 months
- on a stable dose of lipid medication for at least 2 weeks, if prescribed
Key exclusion criteria (19 listed)
- Individuals with the following characteristics/conditions will be excluded
- on insulin
- on steroids
- on warfarin (Coumadin)
- GI disease (gastroparesis, celiac, colitis, Crohn's disease, Inflammatory Bowel Syndrome)
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 |
|---|---|---|
| A canola oil enriched mediterranean dietAlso: A mediterranean weight-reducing diet emphasizing canola oil, Eco-Atkins diet, Low carbohydrate dietary portfolioThe diet will be provided at 60% of calories estimated for stable body weight to encourage weight loss. A high protein canola oil-enriched test bread will be provided as a supplement. | Behavioural | A canola oil enriched mediterranean diet |
| A high wheat fiber dietAlso: DASH-type dietThe diet will be provided at 60% of calories estimated for stable body weight to encourage weight loss. A whole wheat control bread will be provided as a supplement to participants | Behavioural | A high wheat fiber diet |
Primary outcome
change in HbA1c
Time frame: Measured at weeks -2, 0, and then at weeks 8, 10 and 12
The baseline HbA1c will be the average HbA1c of weeks -2 and week 0. The end HbA1c will be the average HbA1c of weeks 8, 10 and 12. Change will be the difference between the end and baseline values
10 secondary outcomes
Change in body weight
Time frame: baseline (week 0) and end (week 12)
blood glucose
Time frame: At weeks 0, 2, 4, 8, 10 and 12
Serum lipids: total cholesterol, LDL-chol, HDL-chol and Triglycerides
Time frame: At weeks 0, 4, 8, 10 and 12
Blood pressure
Time frame: At weeks 0, 4, 8, 10 and 12
24-hour Ambulatory blood pressure profile
Time frame: At weeks -1 and 12
diet history
Time frame: At weeks 0, 2, 4, 8, 10 and 12
C-reactive protein
Time frame: At weeks 0 and 12
Cholesterol absorption
Time frame: At weeks -1 and 12
change in LDL particle size
Time frame: Weeks 0 and 12
urinary analyses
Time frame: week 0 and week 12
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 18 Sep 2018.
- Background: PubMed 18268511Alhassan S, Kim S, Bersamin A, King AC, Gardner CD. Dietary adherence and weight loss success among overweight women: results from the A TO Z weight loss study. Int J Obes (Lond). 2008 Jun;32(6):985-91. doi: 10.1038/ijo.2008.8. Epub 2008 Feb 12.
- Background: PubMed 14963049Anderson JW, Randles KM, Kendall CW, Jenkins DJ. Carbohydrate and fiber recommendations for individuals with diabetes: a quantitative assessment and meta-analysis of the evidence. J Am Coll Nutr. 2004 Feb;23(1):5-17. doi: 10.1080/07315724.2004.10719338.
- Background: PubMed 18635428Shai I, Schwarzfuchs D, Henkin Y, Shahar DR, Witkow S, Greenberg I, Golan R, Fraser D, Bolotin A, Vardi H, Tangi-Rozental O, Zuk-Ramot R, Sarusi B, Brickner D, Schwartz Z, Sheiner E, Marko R, Katorza E, Thiery J, Fiedler GM, Bluher M, Stumvoll M, Stampfer MJ; Dietary Intervention Randomized Controlled Trial (DIRECT) Group. Weight loss with a low-carbohydrate, Mediterranean, or low-fat diet. N Engl J Med. 2008 Jul 17;359(3):229-41. doi: 10.1056/NEJMoa0708681.
- Background: PubMed 19506174Jenkins DJ, Wong JM, Kendall CW, Esfahani A, Ng VW, Leong TC, Faulkner DA, Vidgen E, Greaves KA, Paul G, Singer W. The effect of a plant-based low-carbohydrate ("Eco-Atkins") diet on body weight and blood lipid concentrations in hyperlipidemic subjects. Arch Intern Med. 2009 Jun 8;169(11):1046-54. doi: 10.1001/archinternmed.2009.115.
- Background: PubMed 22100977Guariguata L, Whiting D, Weil C, Unwin N. The International Diabetes Federation diabetes atlas methodology for estimating global and national prevalence of diabetes in adults. Diabetes Res Clin Pract. 2011 Dec;94(3):322-32. doi: 10.1016/j.diabres.2011.10.040. Epub 2011 Nov 17.
- Background: PubMed 11282918Kris-Etherton P, Eckel RH, Howard BV, St Jeor S, Bazzarre TL; Nutrition Committee Population Science Committee and Clinical Science Committee of the American Heart Association. AHA Science Advisory: Lyon Diet Heart Study. Benefits of a Mediterranean-style, National Cholesterol Education Program/American Heart Association Step I Dietary Pattern on Cardiovascular Disease. Circulation. 2001 Apr 3;103(13):1823-5. doi: 10.1161/01.cir.103.13.1823. No abstract available.
- Background: PubMed 19246357Sacks FM, Bray GA, Carey VJ, Smith SR, Ryan DH, Anton SD, McManus K, Champagne CM, Bishop LM, Laranjo N, Leboff MS, Rood JC, de Jonge L, Greenway FL, Loria CM, Obarzanek E, Williamson DA. Comparison of weight-loss diets with different compositions of fat, protein, and carbohydrates. N Engl J Med. 2009 Feb 26;360(9):859-73. doi: 10.1056/NEJMoa0804748.
- Background: PubMed 4337382Friedewald WT, Levy RI, Fredrickson DS. Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge. Clin Chem. 1972 Jun;18(6):499-502. No abstract available.
- Background: PubMed 24500611Jenkins DJ, Wong JM, Kendall CW, Esfahani A, Ng VW, Leong TC, Faulkner DA, Vidgen E, Paul G, Mukherjea R, Krul ES, Singer W. Effect of a 6-month vegan low-carbohydrate ('Eco-Atkins') diet on cardiovascular risk factors and body weight in hyperlipidaemic adults: a randomised controlled trial. BMJ Open. 2014 Feb 5;4(2):e003505. doi: 10.1136/bmjopen-2013-003505.
- Background: PubMed 11445904Gremaud G, Piguet C, Baumgartner M, Pouteau E, Decarli B, Berger A, Fay LB. Simultaneous assessment of cholesterol absorption and synthesis in humans using on-line gas chromatography/ combustion and gas chromatography/pyrolysis/isotope-ratio mass spectrometry. Rapid Commun Mass Spectrom. 2001;15(14):1207-13. doi: 10.1002/rcm.365.
- Derived from this study: PubMed 36156115Jenkins DJ, Jones PJ, Abdullah MM, Lamarche B, Faulkner D, Patel D, Sahye-Pudaruth S, Paquette M, Bashyam B, Pichika SC, Kavanagh ME, Patel P, Liang F, Brown R, Zhao T, Phan M, Mathiyalagan G, Tandon S, Vuksan V, Jovanovski E, Sievenpiper JL, Kendall CW, Leiter LA, Josse RG. Low-carbohydrate vegan diets in diabetes for weight loss and sustainability: a randomized controlled trial. Am J Clin Nutr. 2022 Nov;116(5):1240-1250. doi: 10.1093/ajcn/nqac203. Epub 2023 Feb 10.
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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 J Jenkins, MD principal investigator
St. Michael's Hospital / University of Toronto
Cyril Kendall, PhD study director
University of Toronto
Vladimir Vuksan, PhD study director
Unity Health Toronto
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A canola oil enriched mediterranean diet and A high wheat fiber diet in people with Type 2 Diabetes and Obesity, run by Unity Health Toronto at 3 sites 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 8 inclusion and 19 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 18 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 HbA1c (time frame: Measured at weeks -2, 0, and then at weeks 8, 10 and 12). 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 NCT02245399, which also lists 11 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 18 Sep 2018.