Canola Oil Multi-Centre Intervention Trial II

NCT ID: NCT02029833

Last Updated: 2023-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2016-11-30

Brief Summary

The objectives of the study are to examine the health benefits of dietary canola oils on body composition, specifically on android fat, and weight management. COMIT II will also include analysis of FAEs to elucidate the mechanisms by which canola oil may be modifying body composition. Measurement of endothelial function, inflammatory, adiposity, and insulin sensitivity biomarkers will be done to determine the positive health impact of the changes in body composition achieved through canola oil consumption.

Detailed Description

The proposed multi-center clinical trial would engage the same collaborative team that successfully operationalized COMIT I, namely, the Richardson Centre for Functional Foods and Nutraceuticals (RCFFN) at the University of Manitoba (Winnipeg, Manitoba, Canada), the L'Institut Des Nutraceutiques et des Aliments Fonctionnels (INAF) at Laval University (Quebec City, Quebec, Canada), the Department of Nutritional Sciences at The Pennsylvania State University (University Park, Pennsylvania, USA), the Risk Factor Modification Centre at St. Michael's Hospital (Toronto, Ontario, Canada). St. Boniface Hospital Research (Winnipeg, Manitoba, Canada) will be an additional clinical trial site. The proposed COMIT II research program will proceed as a double blind, randomized crossover study consisting of three treatment phases of six weeks, each separated by a 6-week washout period. Participants will consume a fixed composition of a precisely controlled basal, weight-maintaining diet (35% energy from fat, 50% carbohydrate and 15% protein) supplemented with the following treatment oils: (a) regular canola oil, (b) high stability/ high oleic canola oil and (c) a typical "Western diet" fat intake as a control treatment comprised largely of saturated fat with substantial levels of omega-6 linoleic acid, common to current North American intakes. Treatment oils will be isocalorically incorporated into fruit smoothies made with milk and consumed at breakfast and supper. The clinical segment of COMIT II is expected to be completed by the mid to end of the second year, with sample analyses to be completed by the end of year three.

Conditions

Cardiovascular Disease; Diabetes; Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Regular Canola Oil

60% oleic acid

Group Type: EXPERIMENTAL

Regular Canola Oil

Intervention Type: OTHER

High Oleic Canola Oil

70% oleic acid

Group Type: EXPERIMENTAL

High Oleic Canola Oil

Intervention Type: OTHER

Western Type Diet - Common Dietary Oils

Ghee, Safflower oil, Coconut oil, \& flax oil

Group Type: ACTIVE_COMPARATOR

Western Type Diet - Common Dietary Oils

Intervention Type: OTHER

Interventions

Regular Canola Oil

Intervention Type: OTHER

High Oleic Canola Oil

Intervention Type: OTHER

Western Type Diet - Common Dietary Oils

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Waist circumference ≥94 cm for men and ≥80 cm for women

• Fasting blood glucose of ≥ 5.6 mmol/L
• Triglycerides (TG) ≥1.7 mmol/L
• HDL cholesterol (HDL) <1 mmol/L (males) or <1.3 mmol/L (females)
• Blood pressure ≥130 mmHg (systolic) and/or ≥85 mmHg (diastolic).

Exclusion Criteria

• Kidney, or liver disease, or unstable thyroid disease
• Diabetes mellitus
• Smokers
• Those consuming >1 alcoholic beverage a day for women and >2 for men.
• Any participant taking medication known to affect lipid metabolism or endothelial function

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Penn State University

OTHER

Sponsor Role: collaborator

University of Toronto

OTHER

Sponsor Role: collaborator

Laval University

OTHER

Sponsor Role: collaborator

St. Boniface Hospital

OTHER

Sponsor Role: collaborator

University at Buffalo

OTHER

Sponsor Role: collaborator

Canola Council of Canada

OTHER

Sponsor Role: collaborator

Agriculture and Agri-Food Canada

OTHER_GOV

Sponsor Role: collaborator

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Jones, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

The Pennsylvania State University

University Park, Pennsylvania, United States

St Boniface Hospital Research

Winnipeg, Manitoba, Canada

Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba

Winnipeg, Manitoba, Canada

Institute of Nutrition and Functional Foods, Laval University

Québec, Quebec, Canada

Countries

United States; Canada

References

Hammad SS, Eck P, Sihag J, Chen X, Connelly PW, Lamarche B, Couture P, Guay V, Maltais-Giguere J, West SG, Kris-Etherton PM, Bowen KJ, Jenkins DJA, Taylor CG, Perera D, Wilson A, Castillo S, Zahradka P, Jones PJH. Common Variants in Lipid Metabolism-Related Genes Associate with Fat Mass Changes in Response to Dietary Monounsaturated Fatty Acids in Adults with Abdominal Obesity. J Nutr. 2019 Oct 1;149(10):1749-1756. doi: 10.1093/jn/nxz136.

Reference Type: DERIVED

PMID: 31291447 (View on PubMed)

Bowen KJ, Kris-Etherton PM, West SG, Fleming JA, Connelly PW, Lamarche B, Couture P, Jenkins DJA, Taylor CG, Zahradka P, Hammad SS, Sihag J, Chen X, Guay V, Maltais-Giguere J, Perera D, Wilson A, Juan SCS, Rempel J, Jones PJH. Diets Enriched with Conventional or High-Oleic Acid Canola Oils Lower Atherogenic Lipids and Lipoproteins Compared to a Diet with a Western Fatty Acid Profile in Adults with Central Adiposity. J Nutr. 2019 Mar 1;149(3):471-478. doi: 10.1093/jn/nxy307.

Reference Type: DERIVED

PMID: 30773586 (View on PubMed)

Other Identifiers

B2013:137

Identifier Type: -

Identifier Source: org_study_id