NCT02245399

Brief 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 in overweight diabetic patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
164

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable type-2-diabetes

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 19, 2014

Completed
12 days until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2017

Completed
Last Updated

September 18, 2018

Status Verified

September 1, 2018

Enrollment Period

2.2 years

First QC Date

September 5, 2014

Last Update Submit

September 17, 2018

Conditions

Type 2 DiabetesObesityOverweightCardiovascular Diseases

Keywords

Weight lossDiabetesCardiovascular disease (CVD) riskWeight loss dietmediterranean type dietCanola oilLow-carbohydrate dietGlycemic index

Outcome Measures

Primary Outcomes (1)

  • 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 at weeks -2, 0, and then at weeks 8, 10 and 12

Secondary Outcomes (10)

  • Change in body weight

    baseline (week 0) and end (week 12)

  • blood glucose

    At weeks 0, 2, 4, 8, 10 and 12

  • Serum lipids: total cholesterol, LDL-chol, HDL-chol and Triglycerides

    At weeks 0, 4, 8, 10 and 12

  • Blood pressure

    At weeks 0, 4, 8, 10 and 12

  • 24-hour Ambulatory blood pressure profile

    At weeks -1 and 12

  • +5 more secondary outcomes

Other Outcomes (11)

  • Satiety

    at weeks 0, 2, 4, 8, 10 and 12

  • Taste (palatability) of the study diets, breads and other supplements given

    At weeks 2, 4, 8, 10 and 12

  • The Medical Outcomes Study 36-Item Short Form Questionnaire (SF-36)

    At weeks 0 and 12

  • +8 more other outcomes

Study Arms (2)

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.

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.

Behavioral: A high wheat fiber diet

Interventions

A canola oil enriched mediterranean dietBEHAVIORAL

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.

Also known as: A mediterranean weight-reducing diet emphasizing canola oil, Eco-Atkins diet, Low carbohydrate dietary portfolio
A canola oil enriched mediterranean diet
A high wheat fiber dietBEHAVIORAL

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

Also known as: DASH-type diet
A high wheat fiber diet

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • 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)
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba

Winnipeg, Manitoba, R3T 6C5, Canada

Location

Risk Factor Modification Centre, St. Michael's Hospital

Toronto, Ontario, M5C 2T2, Canada

Location

Institute of Nutraceuticals and Functional Foods, Laval University

Québec, Quebec, G1V 4G2, Canada

Location

Related Publications (11)

  • 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: 18268511BACKGROUND

  • 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: 14963049BACKGROUND

  • 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.

    PMID: 18635428BACKGROUND

  • 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.

    PMID: 19506174BACKGROUND

  • 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: 22100977BACKGROUND

  • 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: 11282918BACKGROUND

  • 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: 19246357BACKGROUND

  • 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: 4337382BACKGROUND

  • 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: 24500611BACKGROUND

  • 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: 11445904BACKGROUND

  • Jenkins 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.

    PMID: 36156115DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2ObesityOverweightCardiovascular DiseasesWeight LossDiabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • David J Jenkins, MD

    St. Michael's Hospital / University of Toronto

    PRINCIPAL INVESTIGATOR

  • Cyril Kendall, PhD

    University of Toronto

    STUDY DIRECTOR

  • Vladimir Vuksan, PhD

    Unity Health Toronto

    STUDY DIRECTOR

  • Peter Jones, PhD

    University of Manitoba

    STUDY DIRECTOR

  • Benoit Lamarche, PhD

    Laval University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2014

First Posted

September 19, 2014

Study Start

October 1, 2014

Primary Completion

December 14, 2016

Study Completion

March 13, 2017

Last Updated

September 18, 2018

Record last verified: 2018-09

Locations

CA(3)