This is the old version of SRDR. The next, SRDRplus is available! Registration of your SRDRPlus account is free and approval is automatic. Click Here to register an SRDRPlus account.

Advanced Search

Study Preview



Study Title and Description

DHA-enriched high-oleic acid canola oil improves lipid profile and lowers predicted cardiovascular disease risk in the canola oil multicenter randomized controlled trial.



Key Questions Addressed
1 RCTs and other Comparative studies
  • Comments Comments (
    0
    ) |

Primary Publication Information
  • Comments Comments (
    0
    ) |
TitleData
Title DHA-enriched high-oleic acid canola oil improves lipid profile and lowers predicted cardiovascular disease risk in the canola oil multicenter randomized controlled trial.
Author Jones PJ., Senanayake VK., Pu S., Jenkins DJ., Connelly PW., Lamarche B., Couture P., Charest A., Baril-Gravel L., West SG., Liu X., Fleming JA., McCrea CE., Kris-Etherton PM.
Country From the Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba, Winnipeg, Canada (PJHJ, VKS, and SP); the Risk Factor Modification Centre (DJAJ) and the Keenan Research Centre for Biomedical Science (PWC), St. Michaels Hospital, University of Toronto, Toronto, Canada; the Institute of Nutrition and Functional Foods, Laval University, Québec City, Canada (BL, PC, AC, and LB-G); the Department of Nutritional Sciences (SGW, XL, JAF, and PMK-E) and the Department of Biobehavioral Health (SGW and CEM), Pennsylvania State University, University Park, PA.
Year 2014
Numbers Pubmed ID: 24829493
16766 (internal)

Secondary Publication Information
UI Title Author Country Year
Plasma fatty acid changes following consumption of dietary oils containing n-3, n-6, and n-9 fatty acids at different proportions: preliminary findings of the Canola Oil Multicenter Intervention Trial (COMIT). Senanayake VK., Pu S., Jenkins DA., Lamarche B., Kris-Etherton PM., West SG., Fleming JA., Liu X., McCrea CE., Jones PJ. Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba, 196 Innovation Drive, SmartPark, Winnipeg, MB R3T 6C5, Canada. peter_jones@umanitoba.ca. 2014
  • Comments Comments (
    0
    ) |



Extraction Form: Comparative Studies
Arms
Number Title Description Comments
1 ALA Canola
  • Comments Comments (
    0
    ) |
2 All n-3 PUFAs (ALA+DHA+EPA) Canola + DHA
  • Comments Comments (
    0
    ) |
3 Placebo CornSaff
  • Comments Comments (
    0
    ) |
4 EXCLUDE ALA FlaxSaff
  • Comments Comments (
    0
    ) |
5 ALA Canola Oleic
  • Comments Comments (
    0
    ) |

Design Details
Question... Follow Up Answer Follow-up Answer
Study Design Trial: Randomized Cross-over
  • Comments Comments (
    0
    ) |
What is the name of this study? (e.g. DART, Physician's Health Study) Canola Oil Multi-center Intervention Trial (COMIT)
  • Comments Comments (
    0
    ) |
Country in which study conducted (where subjects live) Canada
  • Comments Comments (
    0
    ) |
Funding source Industry funded
  • Comments Comments (
    0
    ) |
Eligibility Criteria: Inclusion: any of the following: triglyceride level (TG) ≥1.7 mmol/L, high density lipoprotein cholesterol level (HDL) <1 mmol/L (males) or <1.3 mmol/L (females), blood pressure ≥130 mmHg (systolic) and/or ≥85 mmHg (diastolic) and glucose level ≥5.5 mmol/L, waist circumference ≥94 cm for men and ≥80 cm for women. Exclusion: thyroid disease (unless controlled by medication), diabetes mellitus, kidney disease, liver disease, current smokers, or those consuming more than two alcoholic drinks per week, or medications known to affect lipid metabolism or endothelial function (including aspirin or other non-steroidal anti-inflammatory drugs), cholestyramine, colestipol, niacin, clofibrate, gemfibrozil, probucol, or 3-hydroxy-3-methyl-glutaryl-CoA (HMG-CoA) reductase inhibitors.
  • Comments Comments (
    0
    ) |
Comment about Eligibility Criteria: At the beginning of the study, the Adult Treatment Panel III (ATP III) metabolic syndrome criteria for waist circumference (>102 cm for men and >88 cm for women) were followed [28]. As the trial progressed, the International Diabetes Federation (IDF) metabolic syndrome criteria for waist circumference (≥94 cm for men and ≥80 cm for women) were adopted to identify individuals in the initial stages of abdominal obesity who might benefit from dietary intervention.
  • Comments Comments (
    0
    ) |
Study Population Primary Prevention, Increased CVD Risk (ie, diabetes, metabolic syndrome*, hypertension, dyslipidemia, or chronic kidney disease)
  • Comments Comments (
    0
    ) |
Duration of Intervention 4 weeks
  • Comments Comments (
    0
    ) |
If crossover trial, duration of washout period 4 weeks
  • Comments Comments (
    0
    ) |
At baseline, did all subjects have (per eligibility criteria)...? ... Define: Hypertension ... blood pressure ≥130 mmHg (systolic) and/or ≥85 mmHg (diastolic)
  • Comments Comments (
    0
    ) |
Dyslipidemia ... TG ≥1.7 mmol/L, HDL <1 mmol/L (males) or <1.3 mmol/L (females)
  • Comments Comments (
    0
    ) |
Obesity/Overweight ... waist circumference ≥94 cm for men and ≥80 cm for women
  • Comments Comments (
    0
    ) |
Other ... glucose level ≥5.5 mmol/L
  • Comments Comments (
    0
    ) |
Conflict of interest ... Specify Conflict of interest stated ... All authors report having received grants and funding from food companies
  • Comments Comments (
    0
    ) |
Does the study report a subgroup analysis for an outcome of interest? No
  • Comments Comments (
    0
    ) |
Does the study report a regression analysis with interaction terms for an outcome of interest? No
  • Comments Comments (
    0
    ) |
Does the study report an analysis of the association between n-3 biomarkers and an outcome of interest? No
  • Comments Comments (
    0
    ) |
Study start date(s) 2010
  • Comments Comments (
    0
    ) |


Baseline Characteristics
Question ALA All n-3 PUFAs (ALA+DHA+EPA) Placebo EXCLUDE ALA ALA Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions No data entered.
Baseline characteristics, continuous 46.46
  • Comments Comments (
    0
    ) |
14.18
  • Comments Comments (
    0
    ) |
120.62
  • Comments Comments (
    0
    ) |
16.70
  • Comments Comments (
    0
    ) |
77.04
  • Comments Comments (
    0
    ) |
11.80
  • Comments Comments (
    0
    ) |
5.32
  • Comments Comments (
    0
    ) |
mmol/L
  • Comments Comments (
    0
    ) |
1.05
  • Comments Comments (
    0
    ) |
3.35
  • Comments Comments (
    0
    ) |
mmol/L
  • Comments Comments (
    0
    ) |
0.93
  • Comments Comments (
    0
    ) |
1.22
  • Comments Comments (
    0
    ) |
mmol/L
  • Comments Comments (
    0
    ) |
0.29
  • Comments Comments (
    0
    ) |
1.67
  • Comments Comments (
    0
    ) |
mmol/L
  • Comments Comments (
    0
    ) |
0.88
  • Comments Comments (
    0
    ) |
29.80
  • Comments Comments (
    0
    ) |
4.37
  • Comments Comments (
    0
    ) |
Male, percent 54
  • Comments Comments (
    0
    ) |
Race nd
  • Comments Comments (
    0
    ) |
Comments about baseline data No data entered.
Baseline diet description nd
  • Comments Comments (
    0
    ) |
Baseline omega-3 intake nd
  • Comments Comments (
    0
    ) |
Does this study report baseline omega-3 biomarker data? No
  • Comments Comments (
    0
    ) |



Results & Comparisons


Results Data
Outcome: bp      Population: 51408
Time Point Measure ALA All n-3 PUFAs (ALA+DHA+EPA) Placebo EXCLUDE ALA ALA


0 weeks

N Analyzed 130 130 130 130 130
Mean 77.04 77.04 77.04 77.04 77.04
SE 11.80 11.80 11.80 11.80 11.80


4 weeks

N Analyzed 130 130 130 130 130
Mean 77.07 74.60 77.06 77.60 76.75
SE 4.04 4.04 4.04 4.04 4.04
Outcome: bp      Population: 51409
Time Point Measure ALA All n-3 PUFAs (ALA+DHA+EPA) Placebo EXCLUDE ALA ALA


0 weeks

N Analyzed 130 130 130 130 130
Mean 120.62 120.62 120.62 120.62 120.62
SE 16.70 16.70 16.70 16.70 16.70


4 weeks

N Analyzed 130 130 130 130 130
Mean 119.32 117.43 120.39 120.47 119.39
SE 2.91 2.91 2.91 2.91 2.91
Outcome: lipid      Population: 51410
Time Point Measure ALA All n-3 PUFAs (ALA+DHA+EPA) Placebo EXCLUDE ALA ALA


0 weeks

N Analyzed 130 130 130 130 130
Mean 1.22 1.22 1.22 1.22 1.22
SE 0.29 0.29 0.29 0.29 0.29


4 weeks

N Analyzed 130 130 130 130 130
Mean 1.20 1.30 1.20 1.17 1.18
SE 0.02 0.02 0.02 0.02 0.02
Outcome: lipid      Population: 51411
Time Point Measure ALA All n-3 PUFAs (ALA+DHA+EPA) Placebo EXCLUDE ALA ALA


0 weeks

N Analyzed 130 130 130 130 130
Mean 3.35 3.35 3.35 3.35 3.35
SE 0.93 0.93 0.93 0.93 0.93


4 weeks

N Analyzed 130 130 130 130 130
Mean 2.91 3.02 2.85 2.84 2.86
SE 0.08 0.08 0.08 0.08 0.08
Outcome: lipid      Population: 51412
Time Point Measure ALA All n-3 PUFAs (ALA+DHA+EPA) Placebo EXCLUDE ALA ALA


0 weeks

N Analyzed 130 130 130 130 130
Mean 1.67 1.67 1.67 1.67 1.67
SE 0.88 0.88 0.88 0.88 0.88


4 weeks

N Analyzed 130 130 130 130 130
Mean 1.60 1.25 1.56 1.56 1.64
SE 0.10 0.10 0.10 0.10 0.10
Outcome: lipid      Population: 51413
Time Point Measure ALA All n-3 PUFAs (ALA+DHA+EPA) Placebo EXCLUDE ALA ALA


0 weeks

N Analyzed 130 130 130 130 130


4 weeks

N Analyzed 130 130 130 130 130
Mean 4.29 4.01 4.24 4.28 4.29
SE 0.12 0.12 0.12 0.12 0.12

Adverse Events
Arm or Total Title Description Events (n) At Risk (N) Follow-up time Comments
ALA any No adverse effects of any treatment diets were reported. 0 170 4 weeks
  • Comments Comments (
    0
    ) |
All n-3 PUFAs (ALA+DHA+EPA) 0 170 4 weeks
Placebo 0 170 4 weeks
EXCLUDE ALA 0 170 4 weeks
ALA 0 170 4 weeks

Quality Dimensions
Dimension Value Notes Comments
Was the allocation sequence (RANDOMIZATION METHOD) adequately generated? LOW
  • Comments Comments (
    0
    ) |
Was ALLOCATION adequately concealed (prior to assignment)? LOW
  • Comments Comments (
    0
    ) |
Were PARTICIPANTS adequately BLINDED? LOW
  • Comments Comments (
    0
    ) |
Were OUTCOME ASSESSORS adequately BLINDED? LOW
  • Comments Comments (
    0
    ) |
Incomplete outcome data (ATTRITION BIAS) due to amount, nature or handling of incomplete outcome data HIGH 23.5% dropout rate
  • Comments Comments (
    0
    ) |
Is there evidence of SELECTIVE OUTCOME REPORTING bias (Yes/No)? No
  • Comments Comments (
    0
    ) |
INTENTION-TO-TREAT analysis? (Yes/No) UNCLEAR
  • Comments Comments (
    0
    ) |
Group SIMILARITY AT BASELINE (**GENERAL**) Low cross-over study
  • Comments Comments (
    0
    ) |
Was there incomplete COMPLIANCE with interventions across groups? Low
  • Comments Comments (
    0
    ) |
Group SIMILARITY AT BASELINE (**OMEGA-3**) Low cross-over study
  • Comments Comments (
    0
    ) |
Additional Bias: Bias due to problems not covered elsewhere in the table.
  • Comments Comments (
    0
    ) |
If outcome assessor blinding risk of bias is different for different outcomes (eg, lipids vs. MI), choose HIGH risk of bias and describe in Notes
  • Comments Comments (
    0
    ) |
If attrition risk of bias is different for different outcomes (eg, lipids vs. MI) or different time points (eg, 1 year vs. 5 years), choose HIGH risk of bias and describe in Notes
  • Comments Comments (
    0
    ) |

Quality Rating
No quality rating data was found.