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

NCT ID: NCT01581697

Last Updated: 2012-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Atherosclerosis Hypercholesterolemia

Study Groups

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Oat bran

Group Type EXPERIMENTAL

Oat bran

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Oat bran

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Male/Female
* Age limits 5 years-16 years
Minimum Eligible Age

5 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Quaker Oats Company

INDUSTRY

Sponsor Role collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

Instituto de Cardiologia do Rio Grande do Sul

OTHER

Sponsor Role lead

Responsible Party

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Institute fo Cardiology of Rio Grande do Sul

Locations

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

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Lúcia Campos Pellanda, Doctor

Role: CONTACT

+55 51 32303600 ext. 3820

Carina Leiria, Graduated

Role: CONTACT

+55 51 84214768

Facility Contacts

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Lúcia C Pelanda, Doctor

Role: primary

+55051032303600 ext. 3820

Carina Leiria, Graduated

Role: backup

+55 51 84214768

Other Identifiers

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up 4100/07

Identifier Type: -

Identifier Source: org_study_id

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