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Study Title and Description

Effects of stearidonic acid on serum triacylglycerol concentrations in overweight and obese subjects: a randomized controlled trial.



Key Questions Addressed
1 RCTs and other Comparative studies
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Primary Publication Information
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TitleData
Title Effects of stearidonic acid on serum triacylglycerol concentrations in overweight and obese subjects: a randomized controlled trial.
Author Pieters DJ., Mensink RP.
Country Department of Human Biology, NUTRIM School for Nutrition, Toxicology and Metabolism, Maastricht University Medical Centre, Maastricht, The Netherlands.
Year 2015
Numbers Pubmed ID: 25226826

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


Extraction Form: Comparative Studies
Arms
Number Title Description Comments
1 SDA+ALA Echium oil
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2 Placebo high oleic acid sunflower oil
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Design Details
Question... Follow Up Answer Follow-up Answer
Study Design Trial: Randomized Cross-over
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Country in which study conducted (where subjects live) Netherlands
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Funding source Industry funded
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Eligibility Criteria: Healthy, overweight or slightly obese subjects with a BMI between 25 and 35 kg/m2 and aged between 18 and 70 years, who participated in earlier studies at the department. Inclusion criteria were mean serum Tg <3.0 mmol/l, stable body weight (weight gain or loss <2 kg in the previous 3 months), no indications for treatment of hyperlipidemia, no use of medication or a diet known to affect serum lipid or glucose metabolism, no active CVD, no drug or alcohol abuse, no use of an investigational product within the previous 30 days and willing to sop the consumption of vitamin supplements, fish oil capsules, fatty fish and products rich in plant stanol or sterol esters 3 weeks before the start of the study.
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Study Population Primary Prevention, Increased CVD Risk (ie, diabetes, metabolic syndrome*, hypertension, dyslipidemia, or chronic kidney disease)
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Duration of Intervention 6 weeks
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If crossover trial, duration of washout period at least 2 weeks
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At baseline, did all subjects have (per eligibility criteria)...? ... Define: Dyslipidemia ... not defined but in the discussion, the authors stated that subjects were hypertriglyceridemic
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Obesity/Overweight ... BMI between 25 and 35 kg/m2
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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) July 2011 (extracted from clinicaltrials.gov)
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Baseline Characteristics
Question SDA+ALA Placebo Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions 100
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not defined
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Baseline characteristics, continuous 51
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15
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nd
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nd
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nd
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5.94
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mmol/L
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0.93
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3.69
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mmol/L
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0.73
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1.66
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mmol/L
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0.37
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1.3
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mmol/L
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0.61
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28.9
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3
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nd
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Male, percent 47.2
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Race nd nd nd
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Comments about baseline data this is a crossover trial explicitly asked participants to stop vitamin suppl and fish oil suppl as well as fish intake before the study. Biomarkers data were reported at Table S1 and S2.
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Baseline diet description nd
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Baseline omega-3 intake nd
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Does this study report baseline omega-3 biomarker data? Yes Yes Yes
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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
SDA+ALA nd nd
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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? Yes
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Were OUTCOME ASSESSORS adequately BLINDED? Yes
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Incomplete outcome data (ATTRITION BIAS) due to amount, nature or handling of incomplete outcome data Low risk
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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) No
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Group SIMILARITY AT BASELINE (**GENERAL**) Low righ
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Was there incomplete COMPLIANCE with interventions across groups? Low righ
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Group SIMILARITY AT BASELINE (**OMEGA-3**) Low risk
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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 No
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Quality Rating
Guideline Used Overall Rating