<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02245399</url>
  </required_header>
  <id_info>
    <org_study_id>REB# 14-086</org_study_id>
    <secondary_id>CFC/Fund 200134/496744</secondary_id>
    <nct_id>NCT02245399</nct_id>
  </id_info>
  <brief_title>Canola-Mediterranean Diet Study in T2DM</brief_title>
  <official_title>Canola Enriched Mediterranean Type Weight Loss Diet in Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Unity Health Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Toronto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Laval University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Manitoba</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Canola Council of Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Unity Health Toronto</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to assess whether a Mediterranean-type weight-loss diet, enriched&#xD;
      with canola oil, high in plant protein, and low in carbohydrates will produce blood sugar&#xD;
      control, reduce coronary heart disease (CHD) risk factors and maximize weight loss, better&#xD;
      than conventional higher carbohydrate diets in overweight diabetic patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators plan to assess the effects of increasing both canola oil and plant protein&#xD;
      foods while reducing carbohydrate intake in the context of a Mediterranean type diet on&#xD;
      weight loss, glycemic control and cardiovascular risk factors in type 2 diabetes.&#xD;
&#xD;
      Obesity rates in Western nations have shown a dramatic rise in the last 20 years and diabetes&#xD;
      rates have doubled, a trend which is predicted to be repeated over the next 20 years. In&#xD;
      Canada the predicted cost to the healthcare system in only 7 years will rise to $17 billion.&#xD;
      Weight loss diets (such as Atkins, Eddies, South Beach and Zone) emphasizing carbohydrate&#xD;
      restriction have become increasingly popular for the prevention and treatment of diabetes. As&#xD;
      a result, lower carbohydrate diets are being selected by health conscious members of the&#xD;
      general population including those with diabetes. Because such diets in effect promote a high&#xD;
      intake of protein from animal sources, even in the presence of weight loss, serum cholesterol&#xD;
      levels rise due to increased cholesterol and saturated fat intake; and a further rise in&#xD;
      serum lipids is likely to occur in the long term when weight loss has ceased. On the other&#xD;
      hand, lower carbohydrate dietary patterns that are higher in plant rather than animal fat and&#xD;
      proteins have been associated with improved blood lipids and reduced risk of heart disease&#xD;
      and type 2 diabetes.&#xD;
&#xD;
      The investigators have therefore planned a study in which a weight reducing low carbohydrate,&#xD;
      Mediterranean type diet that is high in plant proteins and canola oil will be compared to a&#xD;
      weight reducing high cereal fibre diet in a 3 month study. 150 overweight and obese&#xD;
      participants with type 2 diabetes will be randomized to one of 2 treatments.&#xD;
&#xD;
      Study visits will be as follows: weeks -2, 0 (for randomization), 2, 4, 8, 10 and 12. Body&#xD;
      measurements, blood pressure and blood samples will be taken at each visit except week 2. The&#xD;
      week 2 visit will be mainly for reinforcement of dietary advice; also body weight will be&#xD;
      measured and blood drawn for fast glucose and HbA1c. Diet records will be reviewed at all&#xD;
      visits. 24 hour urine samples will be collected at week 0 and week 12.&#xD;
&#xD;
      On completion of the 12 week study, participants will be given the option of continuing on&#xD;
      the same diet or trying the opposite diet for a further 12 weeks. Visits will be every 4&#xD;
      weeks for a total of 3 visit. Body measurements, blood pressure and blood samples will be&#xD;
      taken during these visits as in the initial 12 week study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2014</start_date>
  <completion_date type="Actual">March 13, 2017</completion_date>
  <primary_completion_date type="Actual">December 14, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in HbA1c</measure>
    <time_frame>Measured at weeks -2, 0, and then at weeks 8, 10 and 12</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in body weight</measure>
    <time_frame>baseline (week 0) and end (week 12)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blood glucose</measure>
    <time_frame>At weeks 0, 2, 4, 8, 10 and 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum lipids: total cholesterol, LDL-chol, HDL-chol and Triglycerides</measure>
    <time_frame>At weeks 0, 4, 8, 10 and 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>At weeks 0, 4, 8, 10 and 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>24-hour Ambulatory blood pressure profile</measure>
    <time_frame>At weeks -1 and 12</time_frame>
    <description>Measurement will be done using a non-invasive SpaceLabs 90217 Ambulatory BP monitor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>diet history</measure>
    <time_frame>At weeks 0, 2, 4, 8, 10 and 12</time_frame>
    <description>7-day food records brought in at weeks 0, 2, 4, 8, 10 and 12 will be analyzed for macro and micro nutrient intakes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C-reactive protein</measure>
    <time_frame>At weeks 0 and 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cholesterol absorption</measure>
    <time_frame>At weeks -1 and 12</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in LDL particle size</measure>
    <time_frame>Weeks 0 and 12</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>urinary analyses</measure>
    <time_frame>week 0 and week 12</time_frame>
    <description>24 hr urine samples will be analyzed for creatinine, urea, C-peptide, minerals, electrolytes and other dietary biomarkers</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Satiety</measure>
    <time_frame>at weeks 0, 2, 4, 8, 10 and 12</time_frame>
    <description>Using a 9-point bipolar semantic scale where -4 is extremely hungry, 0 is neutral and +4 is uncomfortably full, participants will rate their overall feeling of satiety for the previous week.</description>
  </other_outcome>
  <other_outcome>
    <measure>Taste (palatability) of the study diets, breads and other supplements given</measure>
    <time_frame>At weeks 2, 4, 8, 10 and 12</time_frame>
    <description>Using a scale of 1 (strongly dislike) to 10 (like very much), participants will rate the taste (palatability) of the study diet and supplements including study breads, vegan 'meats' and egg products.</description>
  </other_outcome>
  <other_outcome>
    <measure>The Medical Outcomes Study 36-Item Short Form Questionnaire (SF-36)</measure>
    <time_frame>At weeks 0 and 12</time_frame>
    <description>Survey on quality of life</description>
  </other_outcome>
  <other_outcome>
    <measure>Genetic whole genome testing</measure>
    <time_frame>Week 0 or any other time point</time_frame>
    <description>One time sample collection of buffy coat (from white cells) for future study on gene, diet and chronic disease relationship.</description>
  </other_outcome>
  <other_outcome>
    <measure>complete blood count (CBC)</measure>
    <time_frame>Week 0 and week 12</time_frame>
    <description>Health check at start and end of study</description>
  </other_outcome>
  <other_outcome>
    <measure>Renal function test</measure>
    <time_frame>week 0 and week 12</time_frame>
    <description>Health check at start and end of study</description>
  </other_outcome>
  <other_outcome>
    <measure>Liver function test</measure>
    <time_frame>week 0 and week 12</time_frame>
    <description>Health check at start and end of study</description>
  </other_outcome>
  <other_outcome>
    <measure>Prostatic specific antigen (PSA)</measure>
    <time_frame>week 0 and week 12</time_frame>
    <description>Male participants will undergo this test.</description>
  </other_outcome>
  <other_outcome>
    <measure>sustainability of diet</measure>
    <time_frame>week 10 and week 12</time_frame>
    <description>using a scale of 1 (study diet will be very difficult to sustain) to 10 (study diet will be very easy to sustain) participants will assess how sustainable their assigned diet will be on a long-term basis.</description>
  </other_outcome>
  <other_outcome>
    <measure>Testosterone level</measure>
    <time_frame>week 0 and week 12</time_frame>
    <description>Male participants will undergo this test</description>
  </other_outcome>
  <other_outcome>
    <measure>Estradiol level</measure>
    <time_frame>week 0 and week 12</time_frame>
    <description>Female participants will undergo this test</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">164</enrollment>
  <condition>Type 2 Diabetes</condition>
  <condition>Obesity</condition>
  <condition>Overweight</condition>
  <condition>Cardiovascular Diseases</condition>
  <arm_group>
    <arm_group_label>A canola oil enriched mediterranean diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>A high wheat fiber diet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>A canola oil enriched mediterranean diet</intervention_name>
    <description>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.</description>
    <arm_group_label>A canola oil enriched mediterranean diet</arm_group_label>
    <other_name>A mediterranean weight-reducing diet emphasizing canola oil</other_name>
    <other_name>Eco-Atkins diet</other_name>
    <other_name>Low carbohydrate dietary portfolio</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>A high wheat fiber diet</intervention_name>
    <description>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</description>
    <arm_group_label>A high wheat fiber diet</arm_group_label>
    <other_name>DASH-type diet</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women with type 2 diabetes diagnosed for more than 6 months&#xD;
&#xD;
          -  BMI &gt;27 (non-Asians); BMI &gt;25 (Asians)&#xD;
&#xD;
          -  HbA1c between 6.5% and 8.5% at screening, and at the preparation visit before starting&#xD;
             diet&#xD;
&#xD;
          -  on a stable prescribed dose of oral diabetes medication for at least 2 months&#xD;
&#xD;
          -  on a stable dose of lipid medication for at least 2 weeks, if prescribed&#xD;
&#xD;
          -  on a stable dose of blood pressure medication for at least 1 week, if prescribed&#xD;
&#xD;
          -  have a family physician&#xD;
&#xD;
          -  can keep written food records, with the use of a digital scale&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Individuals with the following characteristics/conditions will be excluded&#xD;
&#xD;
          -  on insulin&#xD;
&#xD;
          -  on steroids&#xD;
&#xD;
          -  on warfarin (Coumadin)&#xD;
&#xD;
          -  GI disease (gastroparesis, celiac, colitis, Crohn's disease, Inflammatory Bowel&#xD;
             Syndrome)&#xD;
&#xD;
          -  history of cancer, except non-melanoma skin cancer (basal cell, squamous cell)&#xD;
&#xD;
          -  major cardiovascular event (stroke, myocardial infarction) in past 6 months&#xD;
&#xD;
          -  major surgery in past 6 months&#xD;
&#xD;
          -  major debilitating disorder&#xD;
&#xD;
          -  liver disease (AST or ALT&gt; 3x the upper limit of normal) except non-alcoholic fatty&#xD;
             liver (NAFL) disease or non-alcoholic steatohepatitis (NASH).&#xD;
&#xD;
          -  hepatitis B or C&#xD;
&#xD;
          -  renal failure (creatinine &gt; 150 mmol/L)&#xD;
&#xD;
          -  serum triglycerides &gt;4.5mmol/L&#xD;
&#xD;
          -  acute or chronic infections (bacterial or viral)&#xD;
&#xD;
          -  chronic inflammatory diseases (e.g. lupus, ulcerative colitis)&#xD;
&#xD;
          -  blood pressure &gt;145/90, unless approved by their family physician&#xD;
&#xD;
          -  alcohol consumption &gt;2 drinks/d&#xD;
&#xD;
          -  food allergies to wheat, canola, or other study food components&#xD;
&#xD;
          -  any condition determined by the investigators to make the subject unsuitable for the&#xD;
             study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David J Jenkins, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Michael's Hospital / University of Toronto</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Cyril Kendall, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Toronto</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Vladimir Vuksan, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Unity Health Toronto</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Peter Jones, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Manitoba</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Benoit Lamarche, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Laval University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3T 6C5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Risk Factor Modification Centre, St. Michael's Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5C 2T2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute of Nutraceuticals and Functional Foods, Laval University</name>
      <address>
        <city>Quebec City</city>
        <state>Quebec</state>
        <zip>G1V 4G2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>18268511</PMID>
  </reference>
  <reference>
    <citation>Anderson 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.</citation>
    <PMID>14963049</PMID>
  </reference>
  <reference>
    <citation>Shai 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. Erratum In: N Engl J Med. 2009 Dec 31;361(27):2681.</citation>
    <PMID>18635428</PMID>
  </reference>
  <reference>
    <citation>Jenkins 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 (&quot;Eco-Atkins&quot;) 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. Erratum In: Arch Intern Med. 2009 Sep 14;169(16):1490.</citation>
    <PMID>19506174</PMID>
  </reference>
  <reference>
    <citation>Guariguata 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.</citation>
    <PMID>22100977</PMID>
  </reference>
  <reference>
    <citation>Kris-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.</citation>
    <PMID>11282918</PMID>
  </reference>
  <reference>
    <citation>Sacks 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.</citation>
    <PMID>19246357</PMID>
  </reference>
  <reference>
    <citation>Friedewald 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.</citation>
    <PMID>4337382</PMID>
  </reference>
  <reference>
    <citation>Jenkins 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.</citation>
    <PMID>24500611</PMID>
  </reference>
  <reference>
    <citation>Gremaud 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.</citation>
    <PMID>11445904</PMID>
  </reference>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>September 5, 2014</study_first_submitted>
  <study_first_submitted_qc>September 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>September 17, 2018</last_update_submitted>
  <last_update_submitted_qc>September 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Weight loss</keyword>
  <keyword>Diabetes</keyword>
  <keyword>Cardiovascular disease (CVD) risk</keyword>
  <keyword>Weight loss diet</keyword>
  <keyword>mediterranean type diet</keyword>
  <keyword>Canola oil</keyword>
  <keyword>Low-carbohydrate diet</keyword>
  <keyword>Glycemic index</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02245399
org study id: REB# 14-086
secondary id: CFC/Fund 200134/496744
nct id: NCT02245399
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: change in HbA1c
time frame: Measured at weeks -2, 0, and then at weeks 8, 10 and 12
description: 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
measure: Change in body weight
time frame: baseline (week 0) and end (week 12)
measure: blood glucose
time frame: At weeks 0, 2, 4, 8, 10 and 12
measure: Serum lipids: total cholesterol, LDL-chol, HDL-chol and Triglycerides
time frame: At weeks 0, 4, 8, 10 and 12
measure: Blood pressure
time frame: At weeks 0, 4, 8, 10 and 12
measure: 24-hour Ambulatory blood pressure profile
time frame: At weeks -1 and 12
description: Measurement will be done using a non-invasive SpaceLabs 90217 Ambulatory BP monitor
measure: diet history
time frame: At weeks 0, 2, 4, 8, 10 and 12
description: 7-day food records brought in at weeks 0, 2, 4, 8, 10 and 12 will be analyzed for macro and micro nutrient intakes.
measure: C-reactive protein
time frame: At weeks 0 and 12
measure: Cholesterol absorption
time frame: At weeks -1 and 12
description: 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.
measure: change in LDL particle size
time frame: Weeks 0 and 12
description: 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
measure: urinary analyses
time frame: week 0 and week 12
description: 24 hr urine samples will be analyzed for creatinine, urea, C-peptide, minerals, electrolytes and other dietary biomarkers
measure: Satiety
time frame: at weeks 0, 2, 4, 8, 10 and 12
description: Using a 9-point bipolar semantic scale where -4 is extremely hungry, 0 is neutral and +4 is uncomfortably full, participants will rate their overall feeling of satiety for the previous week.
measure: Taste (palatability) of the study diets, breads and other supplements given
time frame: At weeks 2, 4, 8, 10 and 12
description: Using a scale of 1 (strongly dislike) to 10 (like very much), participants will rate the taste (palatability) of the study diet and supplements including study breads, vegan 'meats' and egg products.
measure: The Medical Outcomes Study 36-Item Short Form Questionnaire (SF-36)
time frame: At weeks 0 and 12
description: Survey on quality of life
measure: Genetic whole genome testing
time frame: Week 0 or any other time point
description: One time sample collection of buffy coat (from white cells) for future study on gene, diet and chronic disease relationship.
measure: complete blood count (CBC)
time frame: Week 0 and week 12
description: Health check at start and end of study
measure: Renal function test
time frame: week 0 and week 12
description: Health check at start and end of study
measure: Liver function test
time frame: week 0 and week 12
description: Health check at start and end of study
measure: Prostatic specific antigen (PSA)
time frame: week 0 and week 12
description: Male participants will undergo this test.
measure: sustainability of diet
time frame: week 10 and week 12
description: using a scale of 1 (study diet will be very difficult to sustain) to 10 (study diet will be very easy to sustain) participants will assess how sustainable their assigned diet will be on a long-term basis.
measure: Testosterone level
time frame: week 0 and week 12
description: Male participants will undergo this test
measure: Estradiol level
time frame: week 0 and week 12
description: Female participants will undergo this test
arm group label: A canola oil enriched mediterranean diet
arm group type: Experimental
description: 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.
arm group label: A high wheat fiber diet
arm group type: Active Comparator
description: 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.
intervention type: Behavioral
intervention name: A canola oil enriched mediterranean diet
description: 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.
arm group label: A canola oil enriched mediterranean diet
other name: A mediterranean weight-reducing diet emphasizing canola oil
other name: Eco-Atkins diet
other name: Low carbohydrate dietary portfolio
intervention type: Behavioral
intervention name: A high wheat fiber diet
description: 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
arm group label: A high wheat fiber diet
other name: DASH-type diet
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: David J Jenkins, MD
role: Principal Investigator
affiliation: St. Michael's Hospital / University of Toronto
last name: Cyril Kendall, PhD
role: Study Director
affiliation: University of Toronto
last name: Vladimir Vuksan, PhD
role: Study Director
affiliation: Unity Health Toronto
last name: Peter Jones, PhD
role: Study Director
affiliation: University of Manitoba
last name: Benoit Lamarche, PhD
role: Study Director
affiliation: Laval University
facility: 
facility: 
facility: 
country: Canada
citation: 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.
PMID: 18268511
citation: Anderson 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.
PMID: 14963049
citation: Shai 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. Erratum In: N Engl J Med. 2009 Dec 31;361(27):2681.
PMID: 18635428
citation: Jenkins 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. Erratum In: Arch Intern Med. 2009 Sep 14;169(16):1490.
PMID: 19506174
citation: Guariguata 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.
PMID: 22100977
citation: Kris-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.
PMID: 11282918
citation: Sacks 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.
PMID: 19246357
citation: Friedewald 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.
PMID: 4337382
citation: Jenkins 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.
PMID: 24500611
citation: Gremaud 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.
PMID: 11445904
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
mesh term: Diabetes Mellitus, Type 2
mesh term: Overweight