Phytosterol Supplementation and Lipoprotein Subfractions

Not Applicable

Completed

• Conditions: Primary Prevention; Hypercholesterolemia
• Interventions: Dietary Supplement: Phytosterol supplements

• Registration Number: NCT06127732
• Lead Sponsor: Federal University of São Paulo

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).

Study Timeline

• Study Start: 2017-05-01
• Primary Completion: 2018-09-30
• Study Completion: 2022-01-10
• Status Verified: 2023-11
• Study First Submitted: 2023-11-08
• Study First Submitted QC: 2023-11-08
• Last Update Submitted: 2023-11-09
• Study First Posted: 2023-11-13
• Last Update Posted: 2023-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phytosterol	Phytosterol supplements	Participants received diet plus phytosterols (2.6 g of phytosterols per day) prescribed and supplied in 650 mg gelatin capsules, to be used four capsules a day along with meals(Fitocor®, Farmoquímica, Brazil) and divided into two meals.for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Change in total and LDL-cholesterol	12 weeks	Phytosterol suplementation can reduce by 5-10% plasma levels of total- and LDL-cholesterol

Secondary Outcome Measures

Name	Time	Method
Change in LDL subfractions	12 weeks	Phytosterol suplementation can modify LDL subfractions
Change in HDL subfractions	12 weeks	Phytosterol suplementation can modify HDL subfractions
Improvement on quality of LDL particle	12 weeks	Phytosterol supplementation can improve the quality of LDL particle

Trial Locations

Locations (2)

University of Sao Paulo; 🇧🇷 Sao Paulo, Other, Brazil

Federal University of Sao Paulo; 🇧🇷 Sao Paulo, SP, Brazil