Nutritional Counseling Associated With the Ingestion of Oat Bran in Hypercholesterolemic Subjects

Not Applicable

Completed

• Conditions: Dietary Modification
• Interventions: Dietary Supplement: oat bran - 40g; Dietary Supplement: refined rice flour- 40g

• Registration Number: NCT02189200
• Lead Sponsor: Universidade Federal do Rio de Janeiro

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).

Study Timeline

• Study Start: 2012-10
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Study First Submitted: 2014-07-07
• Study First Submitted QC: 2014-07-11
• Study First Posted: 2014-07-14
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-10
• Last Update Posted: 2016-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oat bran group	oat bran - 40g	oat bran (40g per day)
Placebo group	refined rice flour- 40g	refined rice flour (40g per day)

Primary Outcome Measures

Name	Time	Method
Change from baseline in LDL-cholesterol in three months	mesures assessed in baseline, after 30, 60 and 90 days

Secondary Outcome Measures

Name	Time	Method
Change from baseline in glucose profile in three months	mesures assessed in baseline, after 30, 60 and 90 days

Trial Locations

Locations (1)

Instituto Estadual de Cardiologia Aloysio de Castro - IECAC; 🇧🇷 Rio de Janeiro, Brazil