Phytosterol Supplementation and Lipoprotein Subfractions (Phyto)

Effects of Phytosterol Supplementation on Lipoprotein Subfractions and LDL Particle Quality: Primary Prevention Study

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.

Study Overview

• Status: Completed
• Conditions: Hypercholesterolemia; Primary Prevention
• Intervention / Treatment: Dietary supplement: Phytosterol supplements

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 Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Other
    • Sao Paulo, Other, Brazil
      • University of Sao Paulo
  • SP
    • Sao Paulo, SP, Brazil, 04039030
      • Federal University of São Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phytosterol; 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.	Dietary supplement: Phytosterol supplements; Participants were randomized into two groups to receive diet plus phytosterols (DP) for 12 weeks, followed by a 7-day washout period with a second period of intervention, where treatments were switched, and participants received diet alone (D) and were followed for another 12 weeks.
No Intervention: Control: diet alone; Participants received diet alone recommended for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in total and LDL-cholesterol	Phytosterol suplementation can reduce by 5-10% plasma levels of total- and LDL-cholesterol	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in LDL subfractions	Phytosterol suplementation can modify LDL subfractions	12 weeks
Change in HDL subfractions	Phytosterol suplementation can modify HDL subfractions	12 weeks
Improvement on quality of LDL particle	Phytosterol supplementation can improve the quality of LDL particle	12 weeks

Collaborators and Investigators

• Sponsor: Federal University of São Paulo
• Collaborators: University of Sao Paulo
• Investigators: Principal Investigator: Maria C Izar, M.D., Ph.D., Federal University of São Paulo

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): September 30, 2018
• Study Completion (Actual): January 10, 2022

Study Registration Dates

• First Submitted: November 8, 2023
• First Submitted That Met QC Criteria: November 8, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Actual): November 13, 2023
• Last Update Submitted That Met QC Criteria: November 9, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Phytosterols; Lipoproteins; LDL-subfractions; HDL-subfractions
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia
• Other Study ID Numbers: 042778/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD will be shared upon request.
• IPD Sharing Time Frame: After publication, and for one year.
• IPD Sharing Access Criteria: Upon request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No