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Study Title and Description

Low doses of eicosapentaenoic acid and docosahexaenoic acid from fish oil dose-dependently decrease serum triglyceride concentrations in the presence of plant sterols in hypercholesterolemic men and women.



Key Questions Addressed
1 RCTs and other Comparative studies
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Primary Publication Information
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TitleData
Title Low doses of eicosapentaenoic acid and docosahexaenoic acid from fish oil dose-dependently decrease serum triglyceride concentrations in the presence of plant sterols in hypercholesterolemic men and women.
Author Ras RT., Demonty I., Zebregs YE., Quadt JF., Olsson J., Trautwein EA.
Country Unilever Research and Development Vlaardingen, Vlaardingen, The Netherlands rouyanne.ras@unilever.com.
Year 2014
Numbers Pubmed ID: 25122648

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


Extraction Form: Comparative Studies
Arms
Number Title Description Comments
1 Placebo 2.5 g/day plant sterols
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2 "Fish oil" (DHA+EPA) 2.5 g/day plant sterols + 0.9 g/day EPA+DHA
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3 "Fish oil" (DHA+EPA) 2.5 g/day plant sterols + 1.3 g/day EPA+DHA
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4 "Fish oil" (DHA+EPA) 2.5 g/day plant sterols + 1.8 g/day EPA+DHA
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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) Sweden
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Funding source Industry funded
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Eligibility Criteria: apparently healthy; aged 25–75 y; fasting TC concentration between 5 and 8 mmol/L [i.e., borderline-high or high TC concentrations (8) as usually used in studies investigating the effects of PSs on blood lipids]; BMI between 18 and 30 kg/m2; systolic blood pressure #160 mm Hg, diastolic blood pressure #90 mm Hg and heart rate between 50 and 100 beats/min; no use of medication that could influence the study outcomes (e.g., lipid-lowering drugs or antibiotics); no use of nicotine-containing products; 10-y cardiovascular disease risk #10 according to the Systematic Coronary Risk Evaluation (SCORE); willing to comply with the study protocol (e.g., consume test products and follow several dietary and lifestyle restrictions); and having signed the informed and biobank consents
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Study Population Primary Prevention, Healthy
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Duration of Intervention 4 weeks
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Conflict of interest ... Specify Conflict of interest stated ... : J. F. A. Quadt and J. Olsson, no conflicts of interest. R. T. Ras, I. Demonty, and E. A. Trautwein are employed by Unilever Research and Development Vlaardingen, The Netherlands, and Y. E. M. P. Zebregs was employed by Unilever Research and Development at the time of study conduct. Unilever markets food products enriched with plant sterols.
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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) 2011
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Baseline Characteristics
Question Placebo "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions No data entered.
Baseline characteristics, continuous 58.3 55.8 59.9 59.4
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1.5 1.4 1.2 1.3
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127.7 130.0 129.6 126.7
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1.9 1.9 1.8 1.8
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77.5 77.6 79.0 76.8
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1.0 0.9 0.8 1.0
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nd nd nd nd
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6.39 6.49 6.60 6.36
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mmol/L mmol/L mmol/L mmol/L
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.11 0.10 0.12 0.10
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3.91 4.10 4.06 3.89
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mmol/L mmol/L mmol/L mmol/L
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.09 0.09 0.10 0.10
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1.67 1.57 1.68 1.64
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mmol/L mmol/L mmol/L mmol/L
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.06 0.05 0.05 0.04
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1.13 1.11 1.09 1.02
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mmol/L mmol/L mmol/L mmol/L
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.07 0.08 0.06 0.05
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24.6 25.1 25.7 24.3
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.3 0.3 0.3 0.4
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71.1 73.3 73.8 69.7
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Kg Kg Kg Kg
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1.4 1.4 1.5 1.4
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Male, percent 29.7 29.7 22.6 19.4
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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
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Baseline omega-3 intake nd
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Does this study report baseline omega-3 biomarker data? Yes
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Results & Comparisons

No Results found.
Adverse Events
Arm or Total Title Description Events (n) At Risk (N) Follow-up time Comments
Placebo Adverse Event 1 Fever, diarrhea, upset stomach, etc. 6 332 4 wk
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"Fish oil" (DHA+EPA)
"Fish oil" (DHA+EPA)
"Fish oil" (DHA+EPA)

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)? Yes Baseline BP was taken and there was a follow-up clinical encounter, but no follow-up BP measurements were reported.
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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
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Group SIMILARITY AT BASELINE (**OMEGA-3**) Unsure All groups are similar except for the group receiving the highest dose of fist oil
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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
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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.