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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Instituto de Cardiologia do Rio Grande do Sul.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Quaker, Inc.
CNPq Universal
Information provided by:
Instituto de Cardiologia do Rio Grande do Sul
ClinicalTrials.gov Identifier:
NCT01581697
First received: April 17, 2012
Last updated: April 19, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Atherosclerosis
Hypercholesterolemia
Dietary Supplement: Oat bran
Phase 1
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Instituto de Cardiologia do Rio Grande do Sul:

Arms Assigned Interventions
Experimental: Oat bran Dietary Supplement: Oat bran

  Eligibility

Ages Eligible for Study:   5 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male/Female
  • Age limits 5 years-16 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01581697

Contacts
Contact: Lúcia Campos Pellanda, Doctor +55 51 32303600 ext 3820 lupellanda@uol.com.br
Contact: Carina Leiria, Graduated +55 51 84214768 carinaleiria@yahoo.com.br

Locations
Brazil
Instituto de Cardiologia do Rio Grande do Sul - Fundação Universitária de Cardiologia Recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 90620001
Contact: Lúcia C Pelanda, Doctor    +55051032303600 ext 3820    lupellanda@uol.com.br   
Contact: Carina Leiria, Graduated    +55 51 84214768    carinaleiria@yahoo.com.br   
Principal Investigator: Lúcia C Pellanda, Doctors         
Sponsors and Collaborators
Instituto de Cardiologia do Rio Grande do Sul
Quaker, Inc.
CNPq Universal
  More Information

No publications provided

Responsible Party: Impacto do consumo de aveia no perfil lipídico de crianças e adolescentes com dislipidemia atendidas no ambulatório de referência em cardiologia pediátrica preventiva do instituto de cardiologia do rio grande do sul, Institute fo Cardiology of Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT01581697     History of Changes
Other Study ID Numbers: up 4100/07
Study First Received: April 17, 2012
Last Updated: April 19, 2012
Health Authority: Brazil: Ministry of Health

Keywords provided by Instituto de Cardiologia do Rio Grande do Sul:
oat
cholesterol
children
adolescent
Level reduction of ceric cholesterol

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Hypercholesterolemia
Dyslipidemias
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 28, 2014