isolated hypercholesterolemia
Conditions
Interventions
Initially, all recruited participants (n = 80) will go through a phase of adaptation to a restricted diet high in saturated fat (<7% of total energy intake) and cholesterol (<200 mg / day) - in which
Dietary supplement
Sponsors
Hospital Universitário Pedro Ernesto/Universidade do Estado do Rio de Janeiro (UERJ)
Hospital Universitário Pedro Ernesto/Universidade do Estado do Rio de Janeiro (UERJ)
Eligibility
Age
6 Years to 19 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. 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. | — |
Countries
Brazil
Contacts
Public ContactSimone Ribas
Universidade do Estado do Rio de Janeiro- UERJ
Outcome results
None listed