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Study Title and Description

The role of soluble fiber intake in patients under highly effective lipid-lowering therapy.



Key Questions Addressed
1 Is this a fiber intervention study?
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Primary Publication Information
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TitleData
Title The role of soluble fiber intake in patients under highly effective lipid-lowering therapy.
Author Ramos SC., Fonseca FA., Kasmas SH., Moreira FT., Helfenstein T., Borges NC., Moreno RA., Rezende VM., Silva FC., Izar MC.
Country Department of Medicine, Cardiology Division, Federal University of Sao Paulo, São Paulo, SP, Brazil.
Year 2011
Numbers Pubmed ID: 21810257

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


Extraction Form: Fiber Database
Arms
No arms have been defined in this extraction form.

Design Details
Question... Follow Up Answer Follow-up Answer
Year of Publication 2011
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Country of Publication Brazil
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What was the study design? Randomized Controlled Trial (parallel)
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Was the study blinded? blinded endpoints, open label
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Study diet type Weight loss
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Level of feeding control for dietary intervention partial metabolic study; subjects were counseled to follow the Therapeutic Lifestyle Changes of the NCEP/ATP and were provided with lipids lowering drugs (randomized to either rosuvastatin or simvastatin/ezetimibe)
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Sample size 116
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Is there a run-in period? No
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Is there a washout period? No
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Did the administered fiber dose change over the course of the study? No
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What is the age of the population (categorical)? Adults (20+ Years)
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Study population, mean age in years ~59.25
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Study population, age range in years -
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Study Population, mean BMI, kg/m2 29.0
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Study population, BMI Range, kg/m2 -
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Baseline health status Hyperlipidemia/hypercholesterolemia
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Gender (% male) ~80
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Fiber 1-type Soluble Fiber
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Fiber 1-if combination was selected for fiber type, 1st fiber type in combination -
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Fiber 1-if combination was selected for fiber type, 2nd fiber type in combination -
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Fiber 1- dose 1 (g) 6.0
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Fiber 1- dose 2 (g) -
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Fiber 1-Duration of intervention 12 weeks
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Fiber 1-how was the fiber administered? Single Food
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Fiber 2-type -
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Fiber 2-if combination was selected for fiber type, 1st fiber type in combination -
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Fiber 2-if combination was selected for fiber type, 2nd fiber type in combination -
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Fiber 2- dose 1 (g) -
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Fiber 2- dose 2 (g) -
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Fiber 2-Duration of intervention -
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Fiber 2-how was the fiber administered? -
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Fiber 3-type -
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Fiber 3-if combination was selected for fiber type, 1st fiber type in combination -
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Fiber 3-if combination was selected for fiber type, 2nd fiber type in combination -
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Fiber 3- dose 1 (g) -
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Fiber 3- dose 2 (g) -
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Fiber 3-Duration of intervention -
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Fiber 3-how was the fiber administered? -
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Fiber 4-type -
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Fiber 4-if combination was selected for fiber type, 1st fiber type in combination -
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Fiber 4-if combination was selected for fiber type, 2nd fiber type in combination -
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Fiber 4- dose 1 (g) -
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Fiber 4- dose 2 (g) -
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Fiber 4-Duration of intervention -
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Fiber 4-how was the fiber administered? -
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Comparator 1- what was the comparator used in the intervention? matched
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Comparator 1-dose 0.0
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Comparator 1-duration of comparator intervention 12 weeis
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Comparator 1-how was the comparator administered to participants? Unspecified
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Comparator 2- what was the comparator used in the intervention? -
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Comparator 2-dose -
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Comparator 2-duration of comparator intervention -
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Comparator 2-how was the comparator administered to participants? -
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Comparator 3- what was the comparator used in the intervention? -
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Comparator 3-dose -
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Comparator 3-duration of comparator intervention -
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Comparator 3-how was the comparator administered to participants? -
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Comparator 4- what was the comparator used in the intervention? -
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Comparator 4-dose -
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Comparator 4-duration of comparator intervention -
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Comparator 4-how was the comparator administered to participants? -
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Baseline Characteristics
No baseline characteristics have been defined for this extraction form.



Results & Comparisons

No Results found.
Adverse Events
Arm or Total Title Description Comments

Quality Dimensions
No quality dimensions were specified.

Quality Rating
No quality rating data was found.