Clinical trial NCT02189200: Nutritional Counseling Associated With the Ingestion of Oat Bran in Hypercholesterolemic Subjects
Official title: Effect of Nutritional Counseling Associated With the Ingestion of Oat Bran in Hypercholesterolemic Subjects in Secondary Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Modification
Keywords: nutritional counseling
oat bran
dyslipidemia
cardiovascular disease
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
First posted: 2014-07-14
Enrollment: 132
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* LDL-c equal or higher than 130mg/dL fasting lipemia.

Exclusion Criteria:

* patients requiring reduction in daily fluid intake
* patients in use of dietary fiber supplements
* gestation
* lactation

Primary outcomes:
measure: Change from baseline in LDL-cholesterol in three months
timeFrame: mesures assessed in baseline, after 30, 60 and 90 days
Secondary outcomes:
measure: Change from baseline in glucose profile in three months
timeFrame: mesures assessed in baseline, after 30, 60 and 90 days
Other outcomes:
measure: Change from baseline in body mass
timeFrame: mesures in kg, assessed in baseline, after 30, 60 and 90 days
measure: Change from baseline in waist circumference
timeFrame: mesures in cm, assessed in baseline, after 30, 60 and 90 days
measure: Change from baseline in neck circumference
timeFrame: mesures in cm, assessed in baseline, after 30, 60 and 90 days
Locations:
city: Rio de Janeiro
country: Brazil
facility: Instituto Estadual de Cardiologia Aloysio de Castro - IECAC
Study officials:
affiliation: Universidade Federal do Rio de Janeiro
name: Simone R. Souza
role: PRINCIPAL_INVESTIGATOR
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