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Study Title and Description

Potent antihypertensive action of dietary flaxseed in hypertensive patients.



Key Questions Addressed
1 RCTs and other Comparative studies
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Primary Publication Information
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TitleData
Title Potent antihypertensive action of dietary flaxseed in hypertensive patients.
Author Rodriguez-Leyva D., Weighell W., Edel AL., LaVallee R., Dibrov E., Pinneker R., Maddaford TG., Ramjiawan B., Aliani M., Guzman R., Pierce GN.
Country St Boniface Hospital Research Centre, 351 Tache Ave, Winnipeg, Manitoba, Canada R2H 2A6. gpierce@sbrc.ca.
Year 2013
Numbers Pubmed ID: 24126178
15267 (internal)

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


Extraction Form: Comparative Studies
Arms
Number Title Description Comments
1 ALA flaxseed group
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2 Placebo
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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) FlaxPAD (the Flaxseed for Peripheral Arterial Disease Trial)
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Country in which study conducted (where subjects live) Canada
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Funding source Industry funded
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Eligibility Criteria: patients must be >40 years old, had PAD(peripheral artery disease) for > 6 months with ankle brachial index <0.9.
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Comment about Eligibility Criteria: exclusion criteria: inability to walk, bowel disease, moderate to severe renal failure, life expectancy <2 years with high baseline cardiac risk, allergies to any ingredient in the study product, patients who plan to undergo surgery during the course of the trial, and no more than 2 fish meals per week
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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 months
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At baseline, did all subjects have (per eligibility criteria)...? ... Define: Peripheral vascular disease ... nd
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Does the study report a subgroup analysis for an outcome of interest? ... Which subgroups? Yes ... SBP> 140 mm HG at baseline (hypertensive) vs non-hypertensis (SBP<140)
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Study start date(s) 2008
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Baseline Characteristics
Question ALA Placebo Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Baseline Diseases/Conditions 31.8 26.1
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75.4 69.2
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Baseline characteristics, continuous 67.4 65.3 67.3
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skip skip skip
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8.06 9.4 8.5
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143.3 142.4 142.9
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skip skip skip
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22.2 17.5 20.1
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77.0 79.0 77.5
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skip skip skip
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9.5 15.7 12.8
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nd nd nd
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skip 4.5 4.5
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4.4 mmol/L mmol/L
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mmol/L 1.3 1.2
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1.1 2.6 2.5
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2.5 mmol/L mmol/L
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mmol/L 1.0 1.0
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1.0 1.2 1.2
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1.2 mmol/L mmol/L
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mmol/L 0.3 0.3
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0.3 1.7 1.6
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1.6 mmol/L mmol/L
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mmol/L 0.8 0.7
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0.7 28.1 27.8
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27.4 skip skip
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4.4 4.4 4.5
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nd nd nd
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nd nd
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Male, percent nd
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Race nd
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Comments about baseline data No data entered.
Baseline diet description nd nd
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Baseline omega-3 intake nd nd
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Does this study report baseline omega-3 biomarker data? Yes Yes
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Results & Comparisons


Results Data
Outcome: bp      Population: 45082
Time Point Measure ALA Placebo


0 months

N Analyzed 45 42
Mean 77 79
SD 9.5 15.7


1 months

N Analyzed 45 42
Mean 74.5 77


6 months

N Analyzed 45 42
Mean 71.8 78.5
SD 11 10


12 months

N Analyzed 45 42
Mean 71.3 75.4
SD 10.8 9.1
Outcome: bp      Population: 45082
Time Point Measure ALA Placebo


0 months

Mean 81 81.6


1 months

Mean 76 81.8


6 months

Mean 74.9 81
Outcome: bp      Population: 45083
Time Point Measure ALA Placebo


0 months

N Analyzed 45 42
Mean 143.3 142.4
SD 22.2 17.5


1 months

N Analyzed 45 42
Mean 140.4 142.9


6 months

N Analyzed 45 42
Mean 136.2 145.6
SD 22 21


12 months

N Analyzed 45 42
Mean 138.2 144.6
SD 20.4 16.1
Outcome: bp      Population: 45083
Time Point Measure ALA Placebo


0 months

Mean 157.8 154.7


1 months

Mean 148.9 156.1


6 months

Mean 142.6 157.8
Outcome: lipid      Population: 62559
Time Point Measure ALA Placebo


0 months

Mean 1.6 1.7
N Enrolled 43 41
SD 0.7 0.9


1 months

Mean 1.8 1.7
N Enrolled 43 41
SD 0.8 0.7


6 months

Mean 1.8 1.8
N Enrolled 43 41
SD 0.8 0.8


12 months

Mean 1.9 1.7
N Enrolled 43 41
SD 0.9 0.7
Outcome: lipid      Population: 62560
Time Point Measure ALA Placebo


0 months

Mean 2.5 2.6
N Enrolled 43 41
SD 1.0 1.0


1 months

Mean 2.3 2.6
N Enrolled 43 41
SD 1.0 1.0


6 months

Mean 2.2 2.5
N Enrolled 43 41
SD 1.0 1.0


12 months

Mean 2.3 2.4
N Enrolled 43 41
SD 1.1 0.9
Outcome: lipid      Population: 62561
Time Point Measure ALA Placebo


0 months

Mean 1.20 1.21
N Enrolled 43 41
SD 0.33 0.29


1 months

Mean 1.12 1.22
N Enrolled 43 41
SD 0.27 0.33


6 months

Mean 1.11 1.19
N Enrolled 43 41
SD 0.25 0.30


12 months

Mean 1.12 1.22
N Enrolled 43 41
SD 0.25 0.25
Outcome: lipid      Population: 62562
Time Point Measure ALA Placebo


0 months

Mean 3.8 4.0
N Enrolled 43 41
SD 1.2 1.3


1 months

Mean 3.9 4.0
N Enrolled 43 41
SD 1.1 1.3


6 months

Mean 3.8 3.9
N Enrolled 43 41
SD 1.3 1.1


12 months

Mean 3.8 3.8
N Enrolled 43 41
SD 1.3 1.1
Outcome: lipid      Population: 62563
Time Point Measure ALA Placebo


0 months

Mean 2.2 2.2
N Enrolled 43 41
SD 1.0 0.9


1 months

Mean 2.1 2.2
N Enrolled 43 41
SD 1.0 0.9


6 months

Mean 2.1 2.1
N Enrolled 43 41
SD 1.1 0.8


12 months

Mean 2.1 2.0
N Enrolled 43 41
SD 1.1 0.8

Adverse Events
Arm or Total Title Description Events (n) At Risk (N) Follow-up time Comments
ALA "use of flaxseed in PAD patients was relatively safe" "no statistically significant difference between groups in any of these parameters"
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Placebo
ALA Adverse Event 1 Stroke 1 6 months
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Placebo 2 6 months
ALA Adverse Event 1 Myocardial infarction 2 6 months
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Placebo 4 6 months

Quality Dimensions
Dimension Value Notes Comments
Was the allocation sequence (RANDOMIZATION METHOD) adequately generated? Low "randomized trial"
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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 BP, the outcome, has inherently high risk of bias
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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**) Yes
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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 Low
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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 Low
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Quality Rating
No quality rating data was found.