Dyslipidemia (elevated cholesterol total or high LDL- cholesterol)
Conditions
Interventions
Initially,all recruited participants went through a phase of adaptation to a diet restricted in saturated fat(<7%) and cholesterol (<200mg/day) for 6-week to prior to the treatment phase. After this p
FMC Corp, Philadelphia)(placebo) instead of psyllium.
dietary supplement
SP06.051.227
Sponsors
Laboratório de Erros Inatos do Metabolismo- Universidade Federal do Pará
Hospital universitário Pedro Ernesto/UERJ
Eligibility
Age
6 Years to 19 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: Children and adolescents (6-19 years) that had a fasting plasma total cholesterol over 170mg/dL (4,40 mmol/L) or LDL-cholesterol over 110mg/dL (2,84 mmol/dL) concentrations, same after were treated initially with similar diet the National Cholesterol Education Program step 1 diet (saturated low-fat diet (<10% calories total) and cholesterol (< 300 mg/dia), for at least eight weeks. The subjects were all outpatients of the Pediatric Nutrition Division and Adolescent Health Studies Nucleus of the Pedro Ernesto University Hospital in Rio de Janeiro, and only those subjects that signed an Informed Consent Form could participated the study.
Exclusion criteria
Exclusion criteria: Patients with cardiovascular diseases or or other chronic medical conditions were excluded from the study, as were those whose diabetes. Children and adolescents with triacylglycerol concentrations of over 3.39 mmol/L or whose Body Mass Index (BMI) according age was higher than 30 kg/m² or female pregnant were also excluded. Participants were taking lipid-lowering agents, including hypolipemiant functional foods were also excluded the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To comprove an effectiveness of psyllium for the reduction of LDL-cholesterol levels in dyslipidemic children and adolescents investigated in the study. The effectiveness of psyllium was measured through the difference of the concentration of the LDL-C before and after the period of 8 weeks of intervention in each group and enters the two types of treatments (cellulose and psyllium). The effectiveness was considered when the presented results had shown to a percentage of reduction of the séricos levels of LDL-C above 5% (primary outcome). The evaluation biochemist was the method used to measure of the lipídico profile before and after the treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| To comprove a not significant presence to possible adverse effects with respect to the psyllium. This was based on an open-ended question referring to any unusual symptoms or discomfort, or side-effects such as increased defecation, bloating, flatulence or fullness over the preceding period. ;Dietary profile and weight maintenance before and after the treatment by participants. All the participants had its anthropometric (weight, waist circumference, skinfolds thickness) and dietary profiles (record and food frequency questionnaire) measured before and after the treatment. | — |
Countries
Brazil
Contacts
Public ContactLuiz Santana da Silva
Laboratório de Erros Inatos do Metabolismo- Universidade Federal do Pará
Outcome results
None listed