Hypercholesterolemia
Conditions
Interventions
It is a controlled randomized clinical study of two arms, crossover and double blind. A total of 50 people who fill the eligibility criteria will be probablely allocated to one or another intervention
D03.383.663.283.909.875
Sponsors
Hospital das Clínicas da Universidade Estadual de Campinas
New Max Industrial Ltda.
Laboratório de Fitoquímica, farmacologia e Toxicologia experimental da Universidade Estadual de Campinas
Eligibility
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: People aged from 18 years to 75 years; both sexes; with dyslipidemia, characterized by serum levels of Low Density Lipoprotein above 100mg/dL and who are not allergic to annatto or traces of annatto
Exclusion criteria
Exclusion criteria: People with psychiatric disease or other disease that affects the understanding of the consent term; Women who are pregnant or breastfeeding; People with allergy to Urucum; People to whom specific drug is being administered to control high levels of triglycerides; people with comorbidities, including diabetes, cardiovascular disease, several renal failure, hepatitis;active infeccion and participants who make a change in lifestyle that impacts the results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find a reduction in LDL-C, analyzed through the colorimetric enzymatic method, from the finding of a variation of at least 20% in pre and post-intervention measurements | — |
Secondary
| Measure | Time frame |
|---|---|
| A 5% increase in HDL measured by the colorimetric enzymatic method is expected;Glycemia maintenance is expected, measured by the concentration of glucose (enzymatic hexokinase method) and glycosylated hemoglobin (HPLC).;Maintenance of renal function markers assessed using urea (UV kinetics) and creatinine (colorimetric) is expected;Maintenance of liver function markers assessed using ALT, AST and GGT is expected;A 3% increase in the activation of brown adipose tissue is expected, as assessed using the thermographic camera;An increase in the concentration of hormones involved in satiety is expected, which will be evaluated using elisa kits;An increase in the concentration of FGF-21 measured by the Elisa Kit is expected;A modulation of the intestinal microbiota is expected with a reduction in firmicutes and an increase in Arkkemansia evaluated through high-performance sequencing of the V3/V4 regions of the 16S rRNA gene;A 15% reduction in the thyrglyceride is expected between the beginning and end of the intervention measured by the colorimetric enzyme method | — |
Countries
Brazil
Contacts
Public ContactMary ann Foglio
Laboratório de Fitoquímica, farmacologia e Toxicologia experimental da Universidade Estadual de Campinas
Outcome results
None listed