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Study Title and Description

Effects of varying dietary fat, fish, and fish oils on blood lipids in a randomized controlled trial in men at risk of heart disease.



Key Questions Addressed
1 RCTs and other Comparative studies
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Primary Publication Information
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TitleData
Title Effects of varying dietary fat, fish, and fish oils on blood lipids in a randomized controlled trial in men at risk of heart disease.
Author zz_Mori TA., Vandongen R., Beilin LJ., Burke V., Morris J., Ritchie J.
Country Department of Medicine, University of Western Australia, Royal Perth Hospital.
Year 1994
Numbers Pubmed ID: 8172092
15024 (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 40% dietary fat
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2 Fish 40% dietary fat
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3 "Fish oil" (DHA+EPA) 2.6g, 40% dietary fat
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4 Fish + Fish oil 40% dietary fat
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5 "Fish oil" (DHA+EPA) 5.2g, 40% dietary fat
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6 Placebo 30% dietary fat
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7 Fish 30% dietary fat
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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) ... Specify Other(s) [Separate countries with commas]: ... Australia
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Funding source Industry only donated materials (eg, supplements)
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Eligibility Criteria: Healthy, nonsmoking males aged 30-60 y, eating not more than one fish meal per wek or drinking more than an average of 30 mL ethanol (three standard drinks) per day, with high-normal blood pressure (systolic BP 130-159 mm Hg and diastolic BP 80-90 mm Hg) AND lipid level (serum cholesterol 5.2-6.9 mmol/L), AND BMI < 30. Subjects were excluded if they were taking any regular medication; had a history of unstable heart, renal, or liver disease, or hypercholesterolemia; or had asthma and suffered from any major allergies.
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Study Population Primary Prevention, Healthy
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Comment about study design: Population: 'high normal' per authors but BMI<30 will include obese participants, and SBP 130-159 will include HTN participants. I have left the baseline section blank for now.
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Duration of Intervention 12 weeks
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Does the study report a subgroup analysis for an outcome of interest? No
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Study start date(s) 1991 (approx)
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Baseline Characteristics
Question Placebo Fish "Fish oil" (DHA+EPA) Fish + Fish oil "Fish oil" (DHA+EPA) Placebo Fish Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions No data entered.
Baseline characteristics, continuous 45.4 44.2 46.8 44.7 44.9 48.3 45.6 45
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1.4 1.7 1.2 1.5 1.9 2.1 1.6 0.6
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135.8 136.4 137.8 137.1 136.4 136.4 136.0 136.5
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2.1 2.1 2.6 1.7 2.0 3.0 1.7 0.8
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84.7 83.9 85.0 85.0 85.2 84.9 84.8 94.8
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1.4 1.2 1.8 1.5 1.3 2.0 1.1 0.6
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27.8 28.6 27.4 27.8 26.2 26.8 27.5 6.09
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0.6 0.6 0.5 0.5 0.7 0.7 0.6 mmol/L
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0.06
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4.06
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mmol/L
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0.06
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1.24
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mmol/L
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0.02
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1.74
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mmol/L
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0.07
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27.5
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0.2
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Male, percent 100 100 100 100 100 100 100 100
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Race nd nd nd nd nd nd nd nd
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Comments about baseline data No data entered.
Baseline diet description eating not more than one fish meal per week or driking more than an average of 30mL of ethanol per day eating not more than one fish meal per week or driking more than an average of 30mL of ethanol per day eating not more than one fish meal per week or driking more than an average of 30mL of ethanol per day eating not more than one fish meal per week or driking more than an average of 30mL of ethanol per day eating not more than one fish meal per week or driking more than an average of 30mL of ethanol per day eating not more than one fish meal per week or driking more than an average of 30mL of ethanol per day eating not more than one fish meal per week or driking more than an average of 30mL of ethanol per day
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Baseline omega-3 intake nd nd nd nd nd nd nd
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Does this study report baseline omega-3 biomarker data? No
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Results & Comparisons


Results Data
Outcome: lipid      Population: 44651
Time Point Measure Placebo Fish "Fish oil" (DHA+EPA) Fish + Fish oil "Fish oil" (DHA+EPA) Placebo Fish


0 weeks

N Analyzed 18 17 17 17 16 17 18
SE
Percent change in level nd


12 weeks

N Analyzed 18 17 17 17 16 17 18
SE
Percent change in level nd
Outcome: lipid      Population: 44671
Time Point Measure Placebo Fish "Fish oil" (DHA+EPA) Fish + Fish oil "Fish oil" (DHA+EPA) Placebo Fish


0 weeks

N Analyzed 18 17 17 17 16 17 18
SE
Percent change in level
Mean nd


12 weeks

N Analyzed 18 17 17 17 16 17 18
SE
Percent change in level
Mean nd
Outcome: lipid      Population: 44701
Time Point Measure Placebo Fish "Fish oil" (DHA+EPA) Fish + Fish oil "Fish oil" (DHA+EPA) Placebo Fish


0 weeks

N Analyzed 18 17 17 17 16 17 18
SE
Percent change in level
Mean nd


12 weeks

N Analyzed 18 17 17 17 16 17 18
SE
Percent change in level nd

Adverse Events
Arm or Total Title Description Events (n) At Risk (N) Follow-up time Comments
Placebo nd
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Fish
"Fish oil" (DHA+EPA)
Fish + Fish oil
"Fish oil" (DHA+EPA)
Placebo
Fish

Quality Dimensions
Dimension Value Notes Comments
Was the allocation sequence (RANDOMIZATION METHOD) adequately generated? Unsure "The men were then randomly allocated to one of seven groups..."
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Was ALLOCATION adequately concealed (prior to assignment)? Unsure
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Were PARTICIPANTS adequately BLINDED? Unsure
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Were OUTCOME ASSESSORS adequately BLINDED? Unsure
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Incomplete outcome data (ATTRITION BIAS) due to amount, nature or handling of incomplete outcome data High Completers only analysis 138 met criteria and ?randomized, 120 completed, no account of missing data given (distribution across the 7 arms)
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Is there evidence of SELECTIVE OUTCOME REPORTING bias (Yes/No)? Low
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INTENTION-TO-TREAT analysis? (Yes/No) No
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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.