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Study Title and Description

Fish oil in combination with high or low intakes of linoleic acid lowers plasma triacylglycerols but does not affect other cardiovascular risk markers in healthy men.



Key Questions Addressed
1 RCTs and other Comparative studies
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Primary Publication Information
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TitleData
Title Fish oil in combination with high or low intakes of linoleic acid lowers plasma triacylglycerols but does not affect other cardiovascular risk markers in healthy men.
Author Damsgaard CT., Fr√łkiaer H., Andersen AD., Lauritzen L.
Country Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen, DK-1958 Frederiksberg C, Denmark. ctd@life.ku.dk
Year 2008
Numbers Pubmed ID: 18492834
16830 (internal)

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


Extraction Form: Comparative Studies
Arms
Number Title Description Comments
1 "Fish oil" (DHA+EPA) combined with high (S/B) or low (R/K) LA (18:2 n-6)
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2 No intervention combined with high or low LA
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3 "Fish oil" (DHA+EPA) + high LA (18:2 n-6)
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4 "Fish oil" (DHA+EPA) + low LA (18:2 n-6)
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5 No intervention + high LA (18:2 n-6)
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6 No intervention + low LA (18:2 n-6)
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Design Trial: Randomized Factorial Design
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Country in which study conducted (where subjects live) Denmark
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Funding source Industry only donated materials (eg, supplements)
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Eligibility Criteria: healthy males aged 18-40 y with no chronic diseases, no regular medication, and no strong allergies who were smoking <5 cigarettes/week, exercising strenuously <7 h/wk, eating homemade meals >5 d/wk, and consumed butter/margarine/or oil daily.
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Study Population Primary Prevention, Healthy
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Duration of Intervention 8 weeks
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Conflict of interest No conflict of interest (explicitly stated)
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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? ... Which predictors/variables? Yes ... Interaction between capsule (FO) and Fat intervention n-6 (P=0.10).
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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) 2005
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Baseline Characteristics
Question "Fish oil" (DHA+EPA) No intervention "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) No intervention No intervention Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions No data entered.
Baseline characteristics, continuous 26.3 24.9 24.9 25.5
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skip skip skip skip
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4.8 4.9 3.9 4.4
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115 nd nd nd
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skip nd nd nd
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6 nd nd nd
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nd 4.08 3.68 4.12
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nd 2.66 2.33 2.71
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3.99 1.50 1.36 1.50
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2.58 22.9 23.1 23.3
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1.48 skip skip skip
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21.9 1.9 1.9 1.9
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skip 78.2 74.3 79.3
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1.6 10.2 Kg Kg
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73.8 0.20 7.4 9.3
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Kg 0.19 0.11 0.20
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7.9 0.09 0.11 0.18
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0.11 1.28 0.04 0.09
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0.10 mmol/L 0.90 1.01
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0.06 mmol/L mmol/L mmol/L
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0.81 mmol/L mmol/L mmol/L
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mmol/L mmol/L mmol/L mmol/L
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mmol/L mmol/L mmol/L
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mmol/L
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mmol/L
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Male, percent 100
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Race nd
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Comments about baseline data No data entered.
Baseline diet description Protein intake, E%(14), Carb intake E%(53), Fat intake E%(33) Protein intake, E%(15), Carb intake E%(50), Fat intake E%(35) Protein intake, E%(15), Carb intake E%(52), Fat intake E%(33) Protein intake, E%(16), Carb intake E%(50), Fat intake E%(35)
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Baseline omega-3 intake No data entered.
Does this study report baseline omega-3 biomarker data? No
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Results & Comparisons


Results Data
Outcome: lipid      Population: 51926
Time Point Measure "Fish oil" (DHA+EPA) No intervention "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) No intervention No intervention


0 weeks

N Analyzed 17 14 16 17
Mean 1.48 1.50 1.36 1.50
SE 0.06 0.09 0.04 0.09


8 weeks

N Analyzed 17 14 16 17
Mean 1.52 1.54 1.39 1.46
SE 0.07 0.12 0.05 0.10
Outcome: lipid      Population: 51927
Time Point Measure "Fish oil" (DHA+EPA) No intervention "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) No intervention No intervention


0 weeks

N Analyzed 17 14 16 17
Mean 2.58 2.66 2.33 2.71
SE 0.10 0.19 0.11 0.18


8 weeks

N Analyzed 17 14 16 17
Mean 2.66 2.64 2.32 2.55
SE 0.12 0.22 0.13 0.17
Outcome: lipid      Population: 51928
Time Point Measure "Fish oil" (DHA+EPA) No intervention "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) No intervention No intervention


0 weeks

N Analyzed 17 14 16 17
Median 0.81 1.28 0.90 1.01
25th Percentile 0.62 0.74 0.61 0.73
75th Percentile 1.16 1.40 1.24 1.12


8 weeks

N Analyzed 17 14 16 17
Median 0.66 0.63 0.77 0.85
25th Percentile 0.51 0.51 0.64 0.70
75th Percentile 0.81 0.88 0.98 1.19

Adverse Events
Arm or Total Title Description Events (n) At Risk (N) Follow-up time Comments
"Fish oil" (DHA+EPA) nd
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No intervention
"Fish oil" (DHA+EPA)
"Fish oil" (DHA+EPA)
No intervention
No intervention

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 all participants and investigators were unaware of the allocations until the end of the data analysis
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Were OUTCOME ASSESSORS adequately BLINDED? low lipids only measured
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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) Yes
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Group SIMILARITY AT BASELINE (**GENERAL**) low
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Was there incomplete COMPLIANCE with interventions across groups? Low As a measure of compliance and tissue incorporation of the FO, PBMC was analyzed
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Group SIMILARITY AT BASELINE (**OMEGA-3**) low similar diets at baseline, but not directly reported
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Additional Bias: Bias due to problems not covered elsewhere in the table. No
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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 low
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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 low
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Quality Rating
No quality rating data was found.