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Study Title and Description

The effects of long-chain omega-3 fish oils and multivitamins on cognitive and cardiovascular function: a randomized, controlled clinical trial.



Key Questions Addressed
1 RCTs and other Comparative studies
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Primary Publication Information
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TitleData
Title The effects of long-chain omega-3 fish oils and multivitamins on cognitive and cardiovascular function: a randomized, controlled clinical trial.
Author Pase MP., Grima N., Cockerell R., Stough C., Scholey A., Sali A., Pipingas A.
Country a Centre for Human Psychopharmacology , Swinburne University of Technology , Hawthorn , AUSTRALIA.
Year 2015
Numbers Pubmed ID: 25565485

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) 3g + multivitamin
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2 "Fish oil" (DHA+EPA) 6g + multivitamin
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3 "Fish oil" (DHA+EPA) 6g
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4 Placebo
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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) ... Specify Other(s) [Separate countries with commas]: ... Australia
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Funding source Industry funded
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Eligibility Criteria: Participants were eligible if they did not have a diagnosis of dementia, diabetes, neurological or psychiatric disease, or cardiovascular disease. Participants taking medications, cognitive-enhancing supplements, multivitamins, or fish oil supplements were excluded. Current smokers and those with a history of drug abuse (including alcohol) were also excluded.
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Study Population Primary Prevention, Healthy
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Duration of Intervention 16 weeks
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Conflict of interest ... Specify Conflict of interest stated ... The funding body for this trial was Swisse Wellness Pty Ltd., who also provided the fish oil, multivitamin, and control supplements. The National Institute of Integrative Medicine, of which Professor Avni Sali is currently director, receives financial support from Swisse Wellness Pty Ltd. Andrew Pipingas and Avni Sali are currently members of the Scientific Advisory Panel for Swisse Wellness Pty Ltd. Aside from oversight of study design and provision of supplements, Swisse Wellness Pty Ltd. was not involved in any other aspects of the conduct of the trial, including analysis or interpretation of the trial findings.
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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) 2010
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Baseline Characteristics
Question "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) Placebo Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions No data entered.
Baseline characteristics, continuous 58.90 59.48 59.51 59.19
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5.60 5.64 5.96 5.96
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122.59 125.81 121.41 121.41
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16.92 20.97 21.47 21.47
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75.46 77.19 77.71 74.62
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10.90 13.32 9.82 12.13
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nd nd nd nd
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nd nd nd nd
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3.51 3.30 3.37 3.27
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mmol/L mmol/L mmol/L mmol/L
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0.72 0.71 0.84 0.72
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1.61 1.52 1.56 1.57
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mmol/L mmol/L mmol/L mmol/L
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0.39 0.42 0.44 0.36
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1.19 1.22 1.16 1.25
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mmol/L mmol/L mmol/L mmol/L
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0.68 0.50 0.60 0.73
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24.41 25.54 25.31 24.2
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3.07 3.59 4.03 2.79
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nd nd nd
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Male, percent 47.5 47.6 46.3 45.9
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Race nd nd nd nd
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Comments about baseline data No data entered.
Baseline diet description No data entered.
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: 59726
Time Point Measure "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) Placebo


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N Analyzed
Mean
SD
SE
Outcome: bp      Population: 59727
Time Point Measure "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) Placebo


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N Analyzed
Mean
SD
SE

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

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 Lipids were measured at baseline and a follow-up blood sample was taken, but no follow-up lipid measurements are 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**) Low
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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.