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

NCT ID: NCT02189200

Last Updated: 2016-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2014-04-30

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).

Conditions

Dietary Modification

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Oat bran group

oat bran (40g per day)

Group Type: ACTIVE_COMPARATOR

oat bran - 40g

Intervention Type: DIETARY_SUPPLEMENT

oat bran - 40g per day

Placebo group

refined rice flour (40g per day)

Group Type: PLACEBO_COMPARATOR

refined rice flour- 40g

Intervention Type: DIETARY_SUPPLEMENT

refined rice flour - 40g per day

Interventions

oat bran - 40g

oat bran - 40g per day

Intervention Type: DIETARY_SUPPLEMENT

refined rice flour- 40g

refined rice flour - 40g per day

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal do Rio de Janeiro

OTHER

Sponsor Role: lead

Responsible Party

Simone Raimondi de Souza

Dra.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Simone R. Souza

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal do Rio de Janeiro

Locations

Instituto Estadual de Cardiologia Aloysio de Castro - IECAC

Rio de Janeiro, Rio de Janeiro, Brazil

Countries

Brazil

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Related Links

http://apps.who.int/iris/bitstream/10665/43235/1/9241593253_eng.pdf?ua=1

WORLD HEALTH ORGANIZATION. Cardiovascular disease prevention and control. Translating evidence into action, 2005

http://whqlibdoc.who.int/publications/2007/9789241547178_eng.pdf?ua=1

WORLD HEALTH ORGANIZATION. Prevention of cardiovascular disease: guidelines for assessment and management of total cardiovascular risk, 2007

Other Identifiers

03131712.3.0000.5265

Identifier Type: -

Identifier Source: org_study_id