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Study Title and Description

Plant- and marine-derived n-3 polyunsaturated fatty acids have differential effects on fasting and postprandial blood lipid concentrations and on the susceptibility of LDL to oxidative modification in moderately hyperlipidemic subjects.



Key Questions Addressed
1 RCTs and other Comparative studies
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Primary Publication Information
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TitleData
Title Plant- and marine-derived n-3 polyunsaturated fatty acids have differential effects on fasting and postprandial blood lipid concentrations and on the susceptibility of LDL to oxidative modification in moderately hyperlipidemic subjects.
Author Finnegan YE., Minihane AM., Leigh-Firbank EC., Kew S., Meijer GW., Muggli R., Calder PC., Williams CM.
Country Hugh Sinclair Unit of Human Nutrition, School of Food Biosciences, University of Reading, Reading, United Kingdom.
Year 2003
Numbers Pubmed ID: 12663273
87 (internal)

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Comparative Studies
Arms
Number Title Description Comments
1 Placebo Margarine/Capsule
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2 "Fish oil" (DHA+EPA) 0.8g
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3 "Fish oil" (DHA+EPA) 1.7g
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4 ALA 4.5g
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5 EXCLUDE ALA 9.5g
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Design Trial: Randomized Parallel (Omega-3 vs. Control; Omega-3 + X vs. X)
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Country in which study conducted (where subjects live) UK
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Funding source Industry funded
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Eligibility Criteria: Moderately hyperlipidemic but otherwise healthy adults aged 25–72y. Exclusion criteria for participation in the study were evidence of cardiovascular disease, including angina; diagnosed diabetes or a fasting glucose concentration > 6.5 mmol/L; liver or other endocrine dysfunction; pregnancy or lactation; smoking > 15 cigarettes/d; exercising strenuously > 3 times/wk; body mass index (in kg/m2) < 20 or > 32; and a hemoglobin concentration < 130 g/L in men or 120 g/L in women. Individuals who were prescribed hypolipidemic or antiinflammatory medication, took fatty acid or antioxidant supplements regularly, or consumed > 2 portions of oily fish/wk were excluded. Vegetarians and nonconsumers of margarine were also excluded. Moderate hyperlipidemia was defined as a fasting total cholesterol concentration between 4.6 and 8.0 mmol/L and a triacylglycerol concentration between 0.8 and 3.2 mmol/L.
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Study Population Primary Prevention, Healthy
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Duration of Intervention 6 months
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At baseline, did all subjects have (per eligibility criteria)...? ... Define: Dyslipidemia ...
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Conflict of interest No Data regarding conflict of interest
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Does the study report a subgroup analysis for an outcome of interest? No
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Does the study report a regression analysis with interaction terms for an outcome of interest? No
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Does the study report an analysis of the association between n-3 biomarkers and an outcome of interest? No
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Study start date(s) 1998
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Baseline Characteristics
Question Placebo "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) ALA EXCLUDE ALA Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions No data entered.
Baseline characteristics, continuous 55 53 54 52 54
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2 2 2 1 2
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25.8 119.6 118.4 118.2 121.2
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0.6 3.7 2.9 2.9 2.8
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123.2 74.6 74.8 76.0 77.4
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3.7 1.7 2.1 2.0 1.7
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76 nd nd nd nd
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1.6 5.5 5.49 5.62 5.50
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nd mmol/L mmol/L mmol/L 0.17
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5.8 0.16 0.15 0.14 3.46
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mmol/L 3.41 3.42 3.55 0.16
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0.17 mmol/L mmol/L mmol/L 1.43
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3.63 0.17 0.14 0.13 0.07
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mmol/L 1.37 1.34 1.29 1.35
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0.16 mmol/L mmol/L mmol/L 0.08
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1.35 0.07 0.07 0.06 26.5
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mmol/L 1.65 1.60 1.66 0.6
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0.06 mmol/L mmol/L mmol/L 77.9
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1.69 0.14 0.13 0.13 2.7
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mmol/L 27.2 26.1 26.3
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0.11 0.6 0.6 0.6
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74.9 79.1 78.0 77.3
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Kg Kg Kg 2.9
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2.1 2.8 2.5
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Male, percent 60 57 58 57 59
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Race nd nd nd nd nd
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Comments about baseline data No data entered.
Baseline diet description nd nd nd nd nd
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Baseline omega-3 intake No data entered.
Does this study report baseline omega-3 biomarker data? Yes
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Results & Comparisons


Results Data
Outcome: bp      Population: 56068
Time Point Measure Placebo "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) ALA EXCLUDE ALA


0 months

N Analyzed 30 30 31 30 29
Mean 76.0 74.6 74.8 76.0 77.4
SE 1.6 1.7 2.1 2.0 1.7


4 months

Mean 75.2 75.9 73.5 75.9 76.4
SE 1.7 2.0 2.0 2.0 2.4
Outcome: bp      Population: 56069
Time Point Measure Placebo "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) ALA EXCLUDE ALA


0 months

N Analyzed 30 30 31 30 29
Mean 123.2 119.6 118.4 118.2 121.2
SE 3.7 3.7 2.9 2.9 2.8


4 months

Mean 119.1 119.2 114.8 119.3 117.1
SE 3.2 3.9 2.8 3.2 2.7
Outcome: lipid      Population: 56070
Time Point Measure Placebo "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) ALA EXCLUDE ALA


0 months

Mean 1.69 1.65 1.60 1.66 1.35
SE 0.11 0.14 0.13 0.13 0.08
N Analyzed 30 30 29 30 29


2 months

Mean 1.61 1.36 1.35 1.55 1.34
SE 0.12 0.14 0.13 0.15 0.09


4 months

Mean 1.60 1.43 1.46 1.59 1.31
SE 0.13 0.12 0.16 0.13 0.08


6 months

Mean 1.60 1.63 1.40 1.83 1.47
SE 0.11 0.12 0.11 0.16 0.10
Outcome: lipid      Population: 56071
Time Point Measure Placebo "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) ALA EXCLUDE ALA


0 months

Mean 1.35 1.37 1.34 1.29 1.43
SE 0.06 0.07 0.07 0.06 0.07
N Analyzed 30 30 31 30 29


2 months

Mean 1.37 1.39 1.43 1.35 1.43
SE 0.07 0.07 0.08 0.07 0.07


4 months

Mean 1.34 1.41 1.40 1.35 1.47
SE 0.06 0.07 0.08 0.07 0.07


6 months

Mean 1.35 1.45 1.40 1.31 1.46
SE 0.05 0.07 0.08 0.06 0.08
Outcome: lipid      Population: 56072
Time Point Measure Placebo "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) ALA EXCLUDE ALA


0 months

Mean 3.63 3.41 3.42 3.55 3.46
SE 0.16 0.17 0.14 0.13 0.16
N Analyzed 30 30 31 30 29


2 months

Mean 3.59 3.56 3.70 3.58 3.57
SE 0.17 0.15 0.16 0.12 0.17


4 months

Mean 3.60 3.50 3.63 3.63 3.48
SE 0.15 0.17 0.15 0.15 0.16


6 months

Mean 3.84 3.62 3.96 3.71 3.64
SE 0.13 0.18 0.16 0.13 0.17

Adverse Events
Arm or Total Title Description Events (n) At Risk (N) Follow-up time Comments
Placebo nd
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"Fish oil" (DHA+EPA)
"Fish oil" (DHA+EPA)
ALA
EXCLUDE ALA

Quality Dimensions
Dimension Value Notes Comments
Was the allocation sequence (RANDOMIZATION METHOD) adequately generated? Low
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Was ALLOCATION adequately concealed (prior to assignment)? Low
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Were PARTICIPANTS adequately BLINDED? Low
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Were OUTCOME ASSESSORS adequately BLINDED? Low
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Incomplete outcome data (ATTRITION BIAS) due to amount, nature or handling of incomplete outcome data Low
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Is there evidence of SELECTIVE OUTCOME REPORTING bias (Yes/No)? No
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INTENTION-TO-TREAT analysis? (Yes/No) No
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Group SIMILARITY AT BASELINE (**GENERAL**) Low
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Was there incomplete COMPLIANCE with interventions across groups? Low
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Group SIMILARITY AT BASELINE (**OMEGA-3**) Low
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Additional Bias: Bias due to problems not covered elsewhere in the table.
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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
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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
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Quality Rating
No quality rating data was found.