Phytosterol Supplementation and Lipoprotein Subfractions

Hypercholesterolemia Clinical Trial

— Phyto  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06127732
• Other study ID #: 042778/2017
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: January 10, 2022

Study information

• Verified date: November 2023
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: January 10, 2022
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypercholesterolemia
• Primary Prevention

Intervention

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.

Locations

Country	Name	City	State
Brazil	Federal University of Sao Paulo	Sao Paulo	SP
Brazil	University of Sao Paulo	Sao Paulo	Other

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in total and LDL-cholesterol	Phytosterol suplementation can reduce by 5-10% plasma levels of total- and LDL-cholesterol	12 weeks
Secondary	Change in LDL subfractions	Phytosterol suplementation can modify LDL subfractions	12 weeks
Secondary	Change in HDL subfractions	Phytosterol suplementation can modify HDL subfractions	12 weeks
Secondary	Improvement on quality of LDL particle	Phytosterol supplementation can improve the quality of LDL particle	12 weeks