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Study Title and Description

Fish oil and neurovascular control in humans.



Key Questions Addressed
1 RCTs and other Comparative studies
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Primary Publication Information
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TitleData
Title Fish oil and neurovascular control in humans.
Author Carter JR., Schwartz CE., Yang H., Joyner MJ.
Country Department of Kinesiology and Integrative Physiology, Michigan Technological University, Houghton, Michigan 49931, USA. jcarter@mtu.edu
Year 2012
Numbers Pubmed ID: 22707560
15610 (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 oil" (DHA+EPA) fish oil (normotensive)
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2 Placebo Olive oil (normotensive)
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3 "Fish oil" (DHA+EPA) fish oil - prehypertensive
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4 Placebo Olive oil - prehypertensive
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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) US
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Funding source No industry relationship reported (funding or affiliations reported)
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Eligibility Criteria: Normotensive ( resting systolic pressure < 120 mmHg and diastolic pressure <80 mmHg) and prehypertensive (resting systolic pressure of 120-139 mmHg and.or a diastolic pressure of 80-89 mmHg. Exclusion criteria included smoking, diabetes, hypertension, autonomic dysfunction, and use of blood pressure medication. Subjects confirmed they had not been taking any omega-3 fatty acid supplements for >= 2 mo before start of study.
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Study Population Primary Prevention, Healthy
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Duration of Intervention 8 weeks
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Does the study report a subgroup analysis for an outcome of interest? ... Which subgroups? Yes ... normotensive, prehypertensive
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Study start date(s) 2010 (Approx)
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Baseline Characteristics
Question "Fish oil" (DHA+EPA) Placebo "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 24 24 23 25
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2 2 1 3
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110 107 127 126
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1 2 1 2
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66 65 68 74
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1 1 2 2
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80 79 88 92
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1 1 2 1
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nd nd nd nd
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nd nd nd nd
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nd nd nd nd
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nd nd nd nd
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24 24 28 27
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1 1 1 1
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68 70 88 87
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Kg 2 4 2
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3
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Male, percent 90 90 100 92.86
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Race nd nd nd nd
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Comments about baseline data No data entered.
Baseline diet description nd nd nd nd nd
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Baseline omega-3 intake subjects confirmed they had not been taking any omega-3 fatty acid supplements for >= 2 mo before the start of the study subjects confirmed they had not been taking any omega-3 fatty acid supplements for >= 2 mo before the start of the study subjects confirmed they had not been taking any omega-3 fatty acid supplements for >= 2 mo before the start of the study subjects confirmed they had not been taking any omega-3 fatty acid supplements for >= 2 mo before the start of the study subjects confirmed they had not been taking any omega-3 fatty acid supplements for >= 2 mo before the start of the study
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Does this study report baseline omega-3 biomarker data? No
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Results & Comparisons


Results Data
Outcome: bp      Population: 51707
Time Point Measure "Fish oil" (DHA+EPA) Placebo "Fish oil" (DHA+EPA) Placebo


8 weeks

N Analyzed 19 19 15 14
Mean 107 107 125 123
SD
SE 1 2 2 2
Outcome: bp      Population: 51709
Time Point Measure "Fish oil" (DHA+EPA) Placebo "Fish oil" (DHA+EPA) Placebo


8 weeks

N Analyzed 19 19 15 14
Mean 66 66 68 74
SD
SE 1 1 2 2
Outcome: bp      Population: 51710
Time Point Measure "Fish oil" (DHA+EPA) Placebo "Fish oil" (DHA+EPA) Placebo


8 weeks

N Analyzed 19 19 15 14
Mean 80 80 87 90
SD
SE 1 1 1 2

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

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? LOW
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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? UNCLEAR
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Group SIMILARITY AT BASELINE (**OMEGA-3**) Unsure
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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.