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Study Title and Description

Effects of dietary saturated, monounsaturated, and n-3 fatty acids on blood pressure in healthy subjects.



Key Questions Addressed
1 RCTs and other Comparative studies
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Primary Publication Information
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TitleData
Title Effects of dietary saturated, monounsaturated, and n-3 fatty acids on blood pressure in healthy subjects.
Author Rasmussen BM., Vessby B., Uusitupa M., Berglund L., Pedersen E., Riccardi G., Rivellese AA., Tapsell L., Hermansen K.
Country Department of Clinical Endocrinology and Metabolism C, Aarhus University Hospital, Aarhus, Denmark.
Year 2006
Numbers Pubmed ID: 16469978
15029 (internal)

Secondary Publication Information
UI Title Author Country Year
Substituting dietary saturated for monounsaturated fat impairs insulin sensitivity in healthy men and women: The KANWU Study. Vessby B., Uusitupa M., Hermansen K., Riccardi G., Rivellese AA., Tapsell LC., Nälsén C., Berglund L., Louheranta A., Rasmussen BM., Calvert GD., Maffetone A., Pedersen E., Gustafsson IB., Storlien LH. Unit for Clinical Nutrition Research, Department of Public Health and Caring Sciences/Geriatrics, University of Uppsala, Uppsala, Sweden. 2001
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Extraction Form: Comparative Studies
Arms
Number Title Description Comments
1 Placebo +MUFA-rich diet (N=23)
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2 "Fish oil" (DHA+EPA) +MUFA-rich diet (N=24)
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3 Placebo +SFA-rich diet (N=25)
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4 "Fish oil" (DHA+EPA) +SFA-rich diet (N=25)
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5 "Fish oil" (DHA+EPA) FO arms (regardless of diet) (N=49)
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6 Placebo Placebo arms (regardless of diet) (N=48)
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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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What is the name of this study? (e.g. DART, Physician's Health Study) KANWU
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Country in which study conducted (where subjects live) Denmark
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Finland
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Italy
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Sweden
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Other(s) [Separate countries with commas]: ... Australia
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Funding source No industry relationship reported (funding or affiliations reported)
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Eligibility Criteria: Heathly, aged 30-65 years with normal or moderately increased body weight(BMI 22-32 kg/m^2). Subjects with impaired glucose tolerance but without diabetes included.
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Comment about Eligibility Criteria: Excluded if: specific eating habits due to culture/religion, high habitual physical activity, high alcohol intake (>40 g/day), hepatic/cardiac/thyroid/disabling diseases. Body Body weight during the past 3 mo should not have changed
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Study Population Primary Prevention, Healthy
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Duration of Intervention 3 months
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Does the study report a subgroup analysis for an outcome of interest? ... Which subgroups? Yes ... high (>37% of energy) fat intake and low (<37% of energy) fat intake
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Study start date(s) 2009 (Approx)
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Baseline Characteristics
Question Placebo "Fish oil" (DHA+EPA) Placebo "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) Placebo 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 47.0 49.5 49.3 48.5 nd nd nd
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8.8 7.3 7.1 8.0 nd nd nd
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123.1 122.4 121.6 122.7 nd nd nd
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16.6 12.9 11.5 11.4 nd nd nd
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77.8 74.6 77.2 77.1 nd nd nd
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9.9 9.1 7.6 9.0 nd nd nd
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nd nd nd nd nd nd nd
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nd nd nd nd nd nd nd
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nd nd nd nd nd nd nd
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nd nd nd nd nd nd nd
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nd nd nd nd
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26.1 26.5 26.3 26.9
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3.2 3.1 2.7 3.0
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nd nd nd nd
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Male, percent nd nd nd nd nd nd 59%
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Race 100
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all 162 subjects are white
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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? No
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Results & Comparisons


Results Data
Outcome: bp      Population: 44718
Time Point Measure Placebo "Fish oil" (DHA+EPA) Placebo "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) Placebo


0 months

N Analyzed 40 39 42 41 80 82
Mean 77.8 74.6 77.2 77.1 nd nd
SD 9.9 9.1 7.6 9.0 nd nd


3 months

N Analyzed 40 39 42 41 80 82
Mean nd nd nd nd nd nd
SD nd nd nd nd nd nd
Outcome: bp      Population: 44718
Time Point Measure Placebo "Fish oil" (DHA+EPA) Placebo "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) Placebo


0 months

N Analyzed 19 21 21 20
Mean 78.3 74.2 76.2 74.4
SD 11.8 9.0 6.8 8.7
P value 0.0160 0.0897 0.0663 0.6059


3 months

N Analyzed
Mean
SD
Outcome: bp      Population: 44718
Time Point Measure Placebo "Fish oil" (DHA+EPA) Placebo "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) Placebo


0 months

N Analyzed 21 21 21 21
Mean 77.3 74.9 78.2 79.7
SD 8.1 9.6 8.4 8.6
P value 0.1789 0.0224 0.0144 0.2030


3 months

N Analyzed
Mean
SD
P value
Change in Mean (SD)
Percent Change in Mean
Outcome: bp      Population: 44719
Time Point Measure Placebo "Fish oil" (DHA+EPA) Placebo "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) Placebo


0 months

N Analyzed 40 39 42 41 80 82
Mean 123.1 122.4 121.6 122.7 nd nd
SD 16.1 12.9 11.5 11.4 nd nd


3 months

N Analyzed 40 39 42 41 80 82
Mean nd nd nd nd nd nd
Outcome: lipid      Population: 45196
Time Point Measure Placebo "Fish oil" (DHA+EPA) Placebo "Fish oil" (DHA+EPA) "Fish oil" (DHA+EPA) Placebo


0 months

P value
Percent Change in Mean
N Analyzed 23 24 25 25 49 48
Mean 3.66 3.66 3.66 3.66


3 months

P value
Percent Change in Mean

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

Quality Dimensions
Dimension Value Notes Comments
Was the allocation sequence (RANDOMIZATION METHOD) adequately generated? Low "Healthy subjects were randomly assigned..."
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Was ALLOCATION adequately concealed (prior to assignment)? Low
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Were PARTICIPANTS adequately BLINDED? High Diet trials cannot be blinded
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Were OUTCOME ASSESSORS adequately BLINDED? High Outcome: BP "measurements were made 3 times...the data analyzed were the means of the 3 BP values"
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Incomplete outcome data (ATTRITION BIAS) due to amount, nature or handling of incomplete outcome data Low only 1 dropout per group (~40 people in each group)
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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) Yes
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Group SIMILARITY AT BASELINE (**GENERAL**) Low
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Was there incomplete COMPLIANCE with interventions across groups? Low "adherence to the test fats was verified by analyses..."
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Group SIMILARITY AT BASELINE (**OMEGA-3**) Low baseline omega-3 status reported (Table 2)
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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 Lipids(another outcome) would have low risk of bias
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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
Guideline Used Overall Rating