An interventional study of oat bran - 40g and refined rice flour- 40g in Dietary Modification, sponsored by Universidade Federal do Rio de Janeiro. Completed at 1 site in Brazil. Open to participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-05-12.
Sponsored by Universidade Federal do Rio de Janeiro · Not applicable, Interventional, and Treatment
Dyslipidemia is among the risk factors for cardiovascular diseases (CVD). Is's due to genetic and / or environmental factors such as inadequate dietary pattern. The occurrence of adverse events with statins, added to recent questions about their benefits on hard outcomes, opens a gap for the importance of seeking other forms of treatment of dyslipidemia, particularly in patients for secondary prevention. The consumption of oat bran, beta-glucan source of dietary fibers with supposed action in reducing the absorption of exogenous cholesterol and the endogenous synthesis of it, and source of avenanthramides, phytochemical compounds with alleged antioxidant in lipid membranes, can be effective strategy for secondary prevention of atherosclerotic disease.
Objectives: To evaluate the effect of nutritional counseling associated with the consumption of oat bran (40g per day) in lowering cholesterol, glucose profile and anthropometric parameters of subjects in secondary prevention, evaluate the quality of the diet and the intake of processed foods and ingredients added.
Methods: A randomized block, double-blind, placebo-controlled trial lasting 90 days. Inclusion criteria: individuals aged greater than 20 years, both genders, with LDL-c equal or higher than 130mg/dL fasting lipemia. Eligible individuals were considered using oral lipid-lowering, since the dose reported in the early nutritional intervention was maintained during the study. Exclusion criteria: patients requiring reduction in daily fluid intake, supplement use in dietary fiber and gestation / lactation. Data collected: gender; age; education; drugs; body mass (BM), height, body mass index (BMI), waist circumference (WC), neck circumference (NC); blood pressure; dietary surveys, total cholesterol (TC), LDL-C, HDL-cholesterol (HDL-c), triglycerides (TG), fasting glucose (GLU), fasting insulin (INS), HOMA-IR and QUICK. The diet quality was evaluated at baseline and end of study through the Diet Quality Index Revised (IQD-R). The sample size calculation was performed from a pilot study. It came to the need for 63 subjects for each group, oat bran group (GFAV) and placebo group (GPL). The level of statistical significance was 5% (p \<0.05).
Universidade Federal do Rio de Janeiro is the lead sponsor of 120 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
oat bran (40g per day)
Dietary Supplement: oat bran - 40g
refined rice flour (40g per day)
Dietary Supplement: refined rice flour- 40g
oat bran - 40g per day
refined rice flour - 40g per day
Change from baseline in LDL-cholesterol in three months
Time frame: mesures assessed in baseline, after 30, 60 and 90 days
Change from baseline in glucose profile in three months
Time frame: mesures assessed in baseline, after 30, 60 and 90 days
Change from baseline in body mass
Time frame: mesures in kg, assessed in baseline, after 30, 60 and 90 days
Change from baseline in waist circumference
Time frame: mesures in cm, assessed in baseline, after 30, 60 and 90 days
Change from baseline in neck circumference
Time frame: mesures in cm, assessed in baseline, after 30, 60 and 90 days
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Universidade Federal do Rio de Janeiro