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

May 10, 2016 updated by: Simone Raimondi de Souza, Universidade Federal do Rio de Janeiro

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil, 22261-010
        • Instituto Estadual de Cardiologia Aloysio de Castro - IECAC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Oat bran group
oat bran (40g per day)
Dietary supplement: oat bran - 40g
oat bran - 40g per day
Placebo Comparator: Placebo group
refined rice flour (40g per day)
Dietary supplement: refined rice flour- 40g
refined rice flour - 40g per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in LDL-cholesterol in three months
Time Frame: mesures assessed in baseline, after 30, 60 and 90 days
mesures assessed in baseline, after 30, 60 and 90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in glucose profile in three months
Time Frame: mesures assessed in baseline, after 30, 60 and 90 days
mesures assessed in baseline, after 30, 60 and 90 days

Other Outcome Measures

Outcome Measure
Time Frame
Change from baseline in body mass
Time Frame: mesures in kg, assessed in baseline, after 30, 60 and 90 days
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
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
mesures in cm, assessed in baseline, after 30, 60 and 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal do Rio de Janeiro

Investigators

  • Principal Investigator: Simone R. Souza, Universidade Federal do Rio de Janeiro

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

July 7, 2014

First Submitted That Met QC Criteria

July 11, 2014

First Posted (Estimate)

July 14, 2014

Study Record Updates

Last Update Posted (Estimate)

May 12, 2016

Last Update Submitted That Met QC Criteria

May 10, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 03131712.3.0000.5265

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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