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Study Title and Description

Investigation of the effects of a high fish diet on inflammatory cytokines, blood pressure, and lipids in healthy older Australians.



Key Questions Addressed
1 RCTs and other Comparative studies
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Primary Publication Information
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TitleData
Title Investigation of the effects of a high fish diet on inflammatory cytokines, blood pressure, and lipids in healthy older Australians.
Author Grieger JA., Miller MD., Cobiac L.
Country Department of Nutrition and Dietetics, Flinders Clinical and Molecular Medicine, Flinders Medical Centre, Bedford Park, Australia.
Year 2014
Numbers Pubmed ID: 24454276
16805 (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 mixed fish
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2 Low n-3 diet Control (usual diet, eight servings of red meat per fortnight)
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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: community dwelling men and women >= 64 years of age, Inclusion criteria were: BMI >= 18.5 kg/m2 usual consumption of <=1 serving of fish/seafood per week, willing to consume eight servings of fish or red meat per fortnight. Exclusion criteria were: allergies to fish/seafood, vegetarian, intake of lipid-lowering medications; intake of lipid-lowering supplements (e.g. psyllium, fish oil capsules, soy lecithin, phytoestrogens or to cease 3 weeks prior to study commencement), use of anti-inflammatory medications on a regular basis or if experiencing an acute episode within 1 week of the screening visit, presence of diabetes, liver, kidney, thyroid diseases (unless controlled and stable on replacement medication), presence of other endocrine disorders from self-reported medical history, weight loss or gain of 10% body weight in the prior 6 months, or clinically diagnosed depression or dementia.
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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 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 Fish Low n-3 diet Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions No data entered.
Baseline characteristics, continuous nd nd 69.5
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126 126 5.8
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2 2 64,85
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69 67
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1 1
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nd nd
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5.5 5.5
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mmol/L mmol/L
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0.1 0.2
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3.2 3.3
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mmol/L mmol/L
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0.1 0.1
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1.7 1.6
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mmol/L mmol/L
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0.1 0.1
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1.1 1.4
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mmol/L mmol/L
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0.1 0.1
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26.5 26.4
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0.6 0.6
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75.7 73.8
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Kg Kg
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2.2
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Male, percent nd nd 49
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Race nd nd
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Comments about baseline data No data entered.
Baseline diet description nd nd
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Baseline omega-3 intake <= 1 serving of fish/seafood per week
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Does this study report baseline omega-3 biomarker data? Yes
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Results & Comparisons


Results Data
Outcome: bp      Population: 51733
Time Point Measure Fish Low n-3 diet


8 weeks

N Analyzed 43 37
Mean 124 126
SD
SE 3 3
Outcome: bp      Population: 51734
Time Point Measure Fish Low n-3 diet


8 weeks

N Analyzed 43 37
Mean 68 66
SD
SE 2 1
Outcome: lipid      Population: 51736
Time Point Measure Fish Low n-3 diet


8 weeks

N Analyzed 43 37
Mean 3.4 3.2
SD
SE 0.1 0.1
Outcome: lipid      Population: 51738
Time Point Measure Fish Low n-3 diet


8 weeks

N Analyzed 43 37
Mean 1.8 1.7
SD
SE 0.1 0.1
Outcome: lipid      Population: 51739
Time Point Measure Fish Low n-3 diet


8 weeks

N Analyzed 43 37
Mean 1.0 1.3
SD
SE 0.1 0.1

Adverse Events
Arm or Total Title Description Events (n) At Risk (N) Follow-up time Comments
Fish nd
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Low n-3 diet

Quality Dimensions
Dimension Value Notes Comments
Was the allocation sequence (RANDOMIZATION METHOD) adequately generated? UNCLEAR
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Was ALLOCATION adequately concealed (prior to assignment)? UNCLEAR
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Were PARTICIPANTS adequately BLINDED? HIGH participants not blinded
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Were OUTCOME ASSESSORS adequately BLINDED? UNCLEAR
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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
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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.
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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.