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Study Title and Description

Contribution of apolipoprotein E genotype and docosahexaenoic acid to the LDL-cholesterol response to fish oil.



Key Questions Addressed
1 RCTs and other Comparative studies
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Primary Publication Information
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TitleData
Title Contribution of apolipoprotein E genotype and docosahexaenoic acid to the LDL-cholesterol response to fish oil.
Author Olano-Martin E., Anil E., Caslake MJ., Packard CJ., Bedford D., Stewart G., Peiris D., Williams CM., Minihane AM.
Country Hugh Sinclair Unit of Nutrition, School of Chemistry, Food Biosciences and Pharmacy, University of Reading, Reading, UK.
Year 2010
Numbers Pubmed ID: 19748619
16765 (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
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2 EPA 3.3g EPA /day
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3 DHA 3.7g DHA/ day
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Design Trial: Randomized Cross-over
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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: Inclusion criteria for participation were as follows: male, between 18 and 70 years old, body mass index (BMI) 18.5–32 kg/m2, plasma TG 1.0–4.0 mmol/l, plasma total cholesterol (TC) <8 mmol/l, fasting glucose <7 mmol/l, haemoglobin >11 g/dl, and an E3/E3 or E3/E4 genotype. Volunteers were excluded if they had been diagnosed with cardiovascular disease (CVD), diabetes, liver disease or any other endocrine disorder, were taking medication that would affect lipoprotein metabolism, were taking fish oil supplements or consumed more than one portion of oily fish per week, had restrictions on their diet, or were competitive athletes.
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Study Population Primary Prevention, Healthy
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Duration of Intervention 3*4 weeks intervention
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If crossover trial, duration of washout period 10 weeks wash out
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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 E2 and E3 genotype
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Does the study report a regression analysis with interaction terms for an outcome of interest? ... Which predictors/variables? Yes ... treatment*time
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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) 2007 (approx)
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Baseline Characteristics
Question Placebo EPA DHA Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions 0
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0
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0
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0
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Baseline characteristics, continuous ( 5.56 5.58 18,70
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5.44 mmol/L mmol/L nd
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mmol/L 0.16 0.17 nd
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0.14 3.53 3.61 nd
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3.54 mmol/L mmol/L mmol/L
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mmol/L 0.14 0.14 <8
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0.13 1.32 1.31 nd
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1.33 mmol/L mmol/L nd
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mmol/L 0.05 0.05 mmol/L
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0.05 1.62 1.50 1,4
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1.39 mmol/L mmol/L 18.5,32
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mmol/L 0.15 0.11 nd
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0.08
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Male, percent 100
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Race nd nd nd nd
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Comments about baseline data No data entered.
Baseline diet description People were not taking fish oil supplements or consumed more than one portion of oily fish per week, and had not restrictions on their diet.
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Baseline omega-3 intake nd
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Does this study report baseline omega-3 biomarker data? Yes Yes Yes Yes
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Results & Comparisons


Results Data
Outcome: lipid      Population: 51405
Time Point Measure Placebo EPA DHA


0 weeks

N Analyzed 38 38 38
Mean 1.39 1.62 1.50
SE 0.08 0.15 0.11


4 weeks

N Analyzed 38 38 38
Mean 1.41 1.17 1.21
SE 0.11 0.08 0.08
Outcome: lipid      Population: 51406
Time Point Measure Placebo EPA DHA


0 weeks

N Analyzed 38 38 38
Mean 3.54 3.53 3.61
SE 0.13 0.14 0.14


4 weeks

N Analyzed 38 38 38
Mean 3.47 3.54 3.70
SE 0.13 0.16 0.14
Outcome: lipid      Population: 51407
Time Point Measure Placebo EPA DHA


0 weeks

N Analyzed 38 38 38
Mean 3.54 3.53 3.61
SE 0.13 0.14 0.14


4 weeks

N Analyzed 38 38 38
Mean 3.47 3.54 3.70
SE 0.13 0.16 0.14

Adverse Events
Arm or Total Title Description Events (n) At Risk (N) Follow-up time Comments

Quality Dimensions
Dimension Value Notes Comments
Was the allocation sequence (RANDOMIZATION METHOD) adequately generated? No Data no randomization method was listed.
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Was ALLOCATION adequately concealed (prior to assignment)? No Data no conceal mentioned
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Were PARTICIPANTS adequately BLINDED? Yes double blind
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Were OUTCOME ASSESSORS adequately BLINDED? Yes double blind
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Incomplete outcome data (ATTRITION BIAS) due to amount, nature or handling of incomplete outcome data No < 20%
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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 Data not mentioned
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Group SIMILARITY AT BASELINE (**GENERAL**) Yes cross over study
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Was there incomplete COMPLIANCE with interventions across groups? No compliance rate >90%
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Group SIMILARITY AT BASELINE (**OMEGA-3**) Yes cross over study
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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.