Clinical trial NCT06127732: Phytosterol Supplementation and Lipoprotein Subfractions
Official title: Effects of Phytosterol Supplementation on Lipoprotein Subfractions and LDL Particle Quality: Primary Prevention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Primary Prevention
Keywords: Phytosterols
Lipoproteins
LDL-subfractions
HDL-subfractions
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: University of Sao Paulo
First posted: 2023-11-13
Enrollment: 23
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, open-label, crossover intervention study conducted with participants selected by the investigators, and invited to participate in the study.
Primary purpose: TREATMENT

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.

The main questions it aims to answer are:

* do phytosterols reduce LDL-cholesterol and modify LDL and HDL subfractions?
* do phytosterols modify the quality of LDL?

Participants were aleatory selected to diet alone (D) or diet plus phytosterols (DP, 2.6 g divided in two doses, with meals) for 12 weeks, followed by a 7-day washout period, where treatments were switched for another 12-weeks.

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 not following the protocol. Twenty-three individuals were aleatory selected to diet alone (D) or diet plus phytosterols (DP, 2.6 g divided in two doses, with meals) for 12 weeks (w), followed by a 7-day washout period, where treatments were switched for another 12-w.

Study was prospective, randomized, open label, cross-over, with parallel arms and blinded endpoints.

Anthropometry, food consumption and laboratory parameters were evaluated every 12-w.

HDL and LDL subfractions were analyzed by the electrophoresis system in polyacrylamide gel (Lipoprint System®).

Plasma LDL was separated by ultracentrifugation and the quality of the LDL analyzed by nonlinear optical response (Z-scan and UV-vis spectroscopy techniques).

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Change in total and LDL-cholesterol
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in LDL subfractions
timeFrame: 12 weeks
measure: Change in HDL subfractions
timeFrame: 12 weeks
measure: Improvement on quality of LDL particle
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo
state: Other
city: Sao Paulo
country: Brazil
facility: Federal University of Sao Paulo
state: SP
Study officials:
affiliation: Federal University of São Paulo
name: Maria C Izar, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: