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Study Title and Description

White fish reduces cardiovascular risk factors in patients with metabolic syndrome: the WISH-CARE study, a multicenter randomized clinical trial.



Key Questions Addressed
1 RCTs and other Comparative studies
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Primary Publication Information
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TitleData
Title White fish reduces cardiovascular risk factors in patients with metabolic syndrome: the WISH-CARE study, a multicenter randomized clinical trial.
Author Vázquez C., Botella-Carretero JI., Corella D., Fiol M., Lage M., Lurbe E., Richart C., Fernández-Real JM., Fuentes F., Ordóñez A., de Cos AI., Salas-Salvadó J., Burguera B., Estruch R., Ros E., Pastor O., Casanueva FF.
Country Department of Clinical Nutrition and Obesity, Hospital Universitario Ramón y Cajal, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS), Madrid, Spain; CIBER de Fisiopatología de la Obesidad y Nutrición (CIBERobn), Instituto de Salud Carlos III (ISCIII), Spain. Electronic address: cvazquezma@gmail.com.
Year 2014
Numbers Pubmed ID: 24462043

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Comparative Studies
Arms
Number Title Description Comments
1 Fish
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2 No intervention
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Design Trial: Randomized Cross-over
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What is the name of this study? (e.g. DART, Physician's Health Study) The WISH-CARE study
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Country in which study conducted (where subjects live) ... Specify Other(s) [Separate countries with commas]: ... Spain
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Funding source Industry funded
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Eligibility Criteria: Exclusion criteria were the following: patients taking n-3 LCFA supplements, fish allergy and positive antibodies to Anisakis spp., presence of a body mass index (BMI) 40 kg/m2, chronic kidney disease, liver failure, chronic psychopathy, neoplasia or refusal to participate in the study.
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Study Population Primary Prevention, Healthy
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Duration of Intervention 8 weeks
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If crossover trial, duration of washout period 0 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 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) 2011
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Baseline Characteristics
Question Fish No intervention Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions No data entered.
Baseline characteristics, continuous 57.3
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140.5
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83.9
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nd
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197.6
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mg/dL
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119.8
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mg/dL
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46.2
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mg/dL
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170.6
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mg/dL
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32.6
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nd
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Male, percent 52.38%
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Race nd
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Comments about baseline data No data entered.
Baseline diet description table 2: 1.9 white fish servings per week, 0.6 fatty fish servings per week, 0.4 seafood servings per week, 5.4 nut servings per weeks, 17.4 olive oil servings per week, 1 other vegetable serving per week, 0.7 margarine servings per week, 2 butter servings per week
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Baseline omega-3 intake No data entered.
Does this study report baseline omega-3 biomarker data? No
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Results & Comparisons

No Results found.
Adverse Events
Arm or Total Title Description Events (n) At Risk (N) Follow-up time Comments
Fish Adverse Event 1 any adverse event 0 273 8 weeks
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No intervention 0 273 8 weeks

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)? No
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INTENTION-TO-TREAT analysis? (Yes/No) Yes
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Group SIMILARITY AT BASELINE (**GENERAL**) Yes
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Was there incomplete COMPLIANCE with interventions across groups? LOW
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Group SIMILARITY AT BASELINE (**OMEGA-3**) UNCLEAR
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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.