Investigation of the effect of phytosterol consumption (plant extract) on the levels of cholesterol and blood fractions in children and adolescents with abnormal lipid levels in the blood treated at a university hospital.
- Conditions
- isolated hypercholesterolemiacombined hypercholesterolemiaC18.452.584.500.500.396
- Registration Number
- RBR-3h7f9k
- Lead Sponsor
- Hospital Universitário Pedro Ernesto/Universidade do Estado do Rio de Janeiro (UERJ)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
dyslipidemic children and adolescents; both genders; aged 6 to 19 years, patients arising from the Outpatient Nutrition in Pediatrics and the Center for Studies of the University Hospital Adolescent Health Pedro Ernesto; plasma lipid values equal to or greater than 170 mg / dL for total cholesterol after they followed the diet less than seven percent saturated fat and total energy intake less than 200 mg cholesterol per day for a minimum period of four months.
volunteers with preexisting cardiovascular disease; metabolic diseases associated with dyslipidemia; any endocrine disorders. Children and adolescents who present triglyceride levels above 300 mg; use of food or any medications that may cause changes in the lipid profile; pregnant adolescents.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The effectiveness of the phytosterol will be confirmed, if there is reduced at least 5% of serum LDL cholesterol compared to baseline after 8 weeks of the use of phytosterol. In the control group is expected to be no significant reduction. To measure this effect, the biochemical measurement of LDL-cholesterol concentrations at randomization and at the end of the study will be performed.<br><br><br><br><br><br><br><br><br><br><br><br><br><br><br><br><br><br><br><br><br><br><br><br>
- Secondary Outcome Measures
Name Time Method Significant adverse effects related to the consumption of the phytosterol are not expected findings in the study. The information will be obtained through records noted in the study protocol during consultations.<br><br>The expected results no significant changes in eating behavior and adherence to dietary supplement (milk enriched with phytosterols). The evaluation of the diet will be measured through dietary recall survey of 24 hours and adherence to phytosterol for the collection of empty pots at each visit. The total energy, macronutrients, saturated fat percentage and milligrams of cholesterol should not differ statistically between the beginning and end of treatment (p> 0.05) and the pots should return empty at each visit.