Status:
COMPLETED
Phytosterol Supplementation and Lipoprotein Subfractions
Lead Sponsor:
Federal University of São Paulo
Collaborating Sponsors:
University of Sao Paulo
Conditions:
Hypercholesterolemia
Primary Prevention
Eligibility:
MALE
18-65 years
Phase:
NA
Brief Summary
The goal of this clinical trial was to evaluate the effects of phytosterol supplementation to the diet on lipids, LDL and HDL subfractions, and on the quality of LDL in apparently healthy subjects. T...
Detailed Description
Military police from the ROTA (Rondas Ostensivas Tobias de Aguiar, N=60), with hypercholesterolemia in primary prevention were recruited. Of those, 27 did not meet entry criteria, 10 were excluded for...
Eligibility Criteria
Inclusion
- participants of both sexes, aged \>18 and \<65 years, literate, in primary prevention of cardiovascular disease, with LDL-c ≥130mg/dL and \<190 mg/dL and triglycerides \<400 mg/dL.
Exclusion
- secondary causes of dyslipidemia, renal (creatinine \> 2mg/dL), hepatic (AST or ALT \> 1.5 ULN), or metabolic (HbA1c \>8.0%) dysfunction, with BMI \<18.5 or \>40 Kg/m2, recent surgery, disabsortive syndrome, malignancies, under lipid-lowering therapy, unable or unwilling to participate, or with less than 80% adherence to phytosterols
Key Trial Info
Start Date :
May 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 10 2022
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT06127732
Start Date
May 1 2017
End Date
January 10 2022
Last Update
November 13 2023
Active Locations (2)
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1
University of Sao Paulo
São Paulo, Other, Brazil
2
Federal University of Sao Paulo
São Paulo, São Paulo, Brazil, 04039030