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Study Title and Description

Effect of sex and genotype on cardiovascular biomarker response to fish oils: the FINGEN Study.



Key Questions Addressed
1 RCTs and other Comparative studies
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Primary Publication Information
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TitleData
Title Effect of sex and genotype on cardiovascular biomarker response to fish oils: the FINGEN Study.
Author Caslake MJ., Miles EA., Kofler BM., Lietz G., Curtis P., Armah CK., Kimber AC., Grew JP., Farrell L., Stannard J., Napper FL., Sala-Vila A., West AL., Mathers JC., Packard C., Williams CM., Calder PC., Minihane AM.
Country Department of Vascular Biochemistry, Faculty of Medicine, University of Glasgow, Glasgow, United Kingdom.
Year 2008
Numbers Pubmed ID: 18779276
16614 (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 "Fish oil" (DHA+EPA) 0.7g
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3 "Fish oil" (DHA+EPA) 1.8g
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Design Trial: Randomized Cross-over
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What is the name of this study? (e.g. DART, Physician's Health Study) FINGEN
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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: The volunteers were generally fit and healthy. Exclusion criteria for participation in the study were diagnosed diabetes or fasting glucose concentrations of >6.5 mmol/L; liver or other endocrine dysfunction; a myocardial infarction in the previous 2 y; hypolipidemic therapy or any other medication known to interfere with lipid metabolism; consumption of FA supplements or oily fish >1 time/wk; current use of a weight-reducing diet; body mass index (in kg/m2) of <18.5 or >30; or fasting total cholesterol (TC) and TAG concentrations of >8.0 and 3.0 mmol/L, respectively.
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Study Population Primary Prevention, Healthy
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Duration of Intervention three 8-weeks intervention period separated by two 12-weeks washout periods
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If crossover trial, duration of washout period 12 weeks
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Conflict of interest ... Specify Conflict of interest stated ... CMW is a consultant to Pepsico UK and Unilever Plc. PCC is a consultant to Equazen, Royal Dutch Numico, and Mead Johnson Nutritionals and accepts speaking fees from Solvay Healthcare, Solvay Pharmaceuticals, B Braun Melsungen, and Fresenius Kabi. None of the other authors had a personal or financial conflict of interest.
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Does the study report a subgroup analysis for an outcome of interest? ... Which subgroups? Yes ... genotype and sex
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Does the study report a regression analysis with interaction terms for an outcome of interest? ... Which predictors/variables? Yes ... age, sex, genotype
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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) 2003
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Baseline Characteristics
Question Placebo "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions 0
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0
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fasting total cholesterol and TAG concentrations of >8.0 and 3.0 mmol/L, respetively
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0
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MI (in the previous 2 years)
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Baseline characteristics, continuous 45.0
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skip
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0.7
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123
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skip
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1
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74
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skip
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1
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nd
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5.12
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mmol/L
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0.06
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3.22
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mmol/L
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0.05
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1.42
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mmol/L
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0.02
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1.26
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mmol/L
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0.03
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25.2
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skip
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0.19
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73.0
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Kg
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0.8
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Male, percent 47.76%
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Race nd nd nd nd
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Comments about baseline data No data entered.
Baseline diet description nd nd nd
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Baseline omega-3 intake PUFA (% of energy) 4.5+/-0.08 PUFA (% of energy) 4.5+/-0.11 PUFA (% of energy) 4.5+/-0.11
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Does this study report baseline omega-3 biomarker data? Yes
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Results & Comparisons


Results Data
Outcome: lipid      Population: 51133
Time Point Measure Placebo "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA)


0 weeks

N Analyzed 312 312 312
Mean 1.27 1.25 1.28
SE 0.04 0.04 0.04


8 weeks

N Analyzed 312 312 312
Mean 1.28 1.17 1.13
SE 0.04 0.03 0.03
Outcome: lipid      Population: 51133
Time Point Measure Placebo "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA)


0 weeks

N Analyzed 49 49 49
Mean nd
SE nd


8 weeks

N Analyzed 49 49 49
Mean nd
SE nd
Outcome: lipid      Population: 51133
Time Point Measure Placebo "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA)


0 weeks

N Analyzed 38 38 38
Mean nd
SE nd


8 weeks

N Analyzed 38 38 38
Mean nd
SE nd
Outcome: lipid      Population: 51133
Time Point Measure Placebo "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA)


0 weeks

N Analyzed 55 55 55
Mean nd
SE nd


8 weeks

N Analyzed 55 55 55
Mean nd
SE nd
Outcome: lipid      Population: 51133
Time Point Measure Placebo "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA)


0 weeks

N Analyzed 56 56 56
Mean nd
SE nd


8 weeks

N Analyzed 56 56 56
Mean nd
SE nd
Outcome: lipid      Population: 51133
Time Point Measure Placebo "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA)


0 weeks

N Analyzed 59 59 59
Mean nd
SE nd


8 weeks

N Analyzed 59 59 59
Mean nd
SE nd
Outcome: lipid      Population: 51133
Time Point Measure Placebo "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA)


0 weeks

N Analyzed 55 55 55
Mean nd
SE nd


8 weeks

N Analyzed 55 55 55
Mean nd
SE nd
Outcome: lipid      Population: 51133
Time Point Measure Placebo "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA)


0 weeks

N Analyzed 163 163 163
Mean nd
SE nd


8 weeks

N Analyzed 163 163 163
Mean nd
SE nd
Outcome: lipid      Population: 51133
Time Point Measure Placebo "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA)


0 weeks

N Analyzed 149 149 149
Mean nd
SE nd


8 weeks

N Analyzed 149 149 149
Mean nd
SE nd
Outcome: lipid      Population: 51133
Time Point Measure Placebo "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA)


0 weeks

N Analyzed 87 87 87
Mean nd
SE nd


8 weeks

N Analyzed 87 87 87
Mean nd
SE nd
Outcome: lipid      Population: 51133
Time Point Measure Placebo "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA)


0 weeks

N Analyzed 111 111 111
Mean nd
SE nd


8 weeks

N Analyzed 111 111 111
Mean nd
SE nd
Outcome: lipid      Population: 51133
Time Point Measure Placebo "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA)


0 weeks

N Analyzed 114 114 114
Mean nd
SE nd


8 weeks

N Analyzed 114 114 114
Mean nd
SE nd
Outcome: lipid      Population: 51134
Time Point Measure Placebo "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA)


0 weeks

N Analyzed 312 312 312
Mean 3.23 3.26 3.26
SE 0.05 0.05 0.05


8 weeks

N Analyzed 312 312 312
Mean 3.28 3.38 3.38
SE 0.05 0.05 0.06
Outcome: lipid      Population: 51135
Time Point Measure Placebo "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA)


0 weeks

N Analyzed 312 312 312
Mean 1.44 1.43 1.44
SE 0.02 0.02 0.02


8 weeks

N Analyzed 312 312 312
Mean 1.44 1.49 1.50
SE 0.02 0.02 0.02

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? Yes The randomization of subjects to treatment order (ABC, ACB, BCA, BAC, CAB, or CBA) was achieved by using a computer-generated random-number table.
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Was ALLOCATION adequately concealed (prior to assignment)? No Data
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Were PARTICIPANTS adequately BLINDED? Yes double-blinded
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Were OUTCOME ASSESSORS adequately BLINDED? Yes double-blinded
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Incomplete outcome data (ATTRITION BIAS) due to amount, nature or handling of incomplete outcome data No less than 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
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Group SIMILARITY AT BASELINE (**GENERAL**) Yes
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Was there incomplete COMPLIANCE with interventions across groups? No compliance >90%
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Group SIMILARITY AT BASELINE (**OMEGA-3**) Yes
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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.