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Impact of Consumption of Oats in Lipid Profile of Children and Adolescents With Dyslipidemia

Primary Purpose

Atherosclerosis, Hypercholesterolemia

Status
Unknown status
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Oat bran
Sponsored by
Instituto de Cardiologia do Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Atherosclerosis focused on measuring oat, cholesterol, children, adolescent, Level reduction of ceric cholesterol

Eligibility Criteria

5 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Male/Female
  • Age limits 5 years-16 years

Sites / Locations

  • Instituto de Cardiologia do Rio Grande do Sul - Fundação Universitária de CardiologiaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oat bran

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 17, 2012
Last Updated
April 19, 2012
Sponsor
Instituto de Cardiologia do Rio Grande do Sul
Collaborators
Quaker Oats Company, CNPq Universal
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1. Study Identification

Unique Protocol Identification Number
NCT01581697
Brief Title
Impact of Consumption of Oats in Lipid Profile of Children and Adolescents With Dyslipidemia
Official Title
Impact of Consumption of Oats in Lipid Profile of Children and Adolescents With Dyslipidemia at the Outpatient Clinic of Reference in Preventive Pediatric Cardiology at the Institute of Cardiology of Rio Grande do Sul
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Instituto de Cardiologia do Rio Grande do Sul
Collaborators
Quaker Oats Company, CNPq Universal

4. Oversight

5. Study Description

Brief Summary
Atherosclerosis is the leading cause of death and disability in adults. However, investigations suggest that the basic pathology of heart disease as more severe myocardial infarction which usually reach mainly middle-aged or above, starts from childhood. Hypercholesterolemia is one of the most important risk factors for atherosclerosis in adults and children, is associated with early deposition of lipids in the aorta and coronary arteries. Among other recommendations for prevention and treatment of heart disease and risk factors, is the recommendation to encourage the intake of soluble fiber. The oats, a major source of soluble fiber, has been recognized as a potential component of the diet to lower blood cholesterol levels, this effect is attributed mainly to the beta-glucan, a type of soluble fiber present in large quantities in oats. In 1997 the Food and Drug Administration admitted that the oat bran, oat flakes and oatmeal may have beneficial effects for health with the recommendation of daily intake of 3g of beta-glucan from oats and a food that brings a claim for promotion health, must provide, without enrichment, at least 1 gram of beta-glucan per serving. The objective of this project will be compared by randomized clinical trial, the impact of intake of oats, for 8 weeks in the lipid profile of children and adolescents with dyslipidemia. Will be included in the study 120 volunteers aged between 5 and 16 years who are in nutritional monitoring for at least 1 month. The subjects will be randomly divided into 2 groups, with a control group and another intervention will receive 3 tablespoons of soup filled with oat bran, which corresponds to 3g of beta-glucan, along with breakfast, lunch and dinner. Patients will be monitored with consultations on the 2nd, 4th and 8th weeks of treatment. Blood sample will be performed, to obtain the lipid profile of patients, at the beginning and end of the study. To compare the groups are used Student's t and squared chi. The alpha of 0.05 is considered critical. The program will be used Statistical Package for the Social Sciences (SPSS) version 15.0. It is expected a decrease in serum levels of total cholesterol and LDL-c. Thus, living habits and healthy alternatives to prevent these risk factors should be done since childhood, especially in children who already have cholesterol levels of change.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis, Hypercholesterolemia
Keywords
oat, cholesterol, children, adolescent, Level reduction of ceric cholesterol

7. Study Design

Study Phase
Phase 1, Phase 2

8. Arms, Groups, and Interventions

Arm Title
Oat bran
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Oat bran

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male/Female Age limits 5 years-16 years
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lúcia Campos Pellanda, Doctor
Phone
+55 51 32303600
Ext
3820
Email
lupellanda@uol.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Carina Leiria, Graduated
Phone
+55 51 84214768
Email
carinaleiria@yahoo.com.br
Facility Information:
Facility Name
Instituto de Cardiologia do Rio Grande do Sul - Fundação Universitária de Cardiologia
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90620001
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lúcia C Pelanda, Doctor
Phone
+55051032303600
Ext
3820
Email
lupellanda@uol.com.br
First Name & Middle Initial & Last Name & Degree
Carina Leiria, Graduated
Phone
+55 51 84214768
Email
carinaleiria@yahoo.com.br
First Name & Middle Initial & Last Name & Degree
Lúcia C Pellanda, Doctors

12. IPD Sharing Statement

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Impact of Consumption of Oats in Lipid Profile of Children and Adolescents With Dyslipidemia

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