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Completed

NCT Number: NCT06127732

Phytosterol Supplementation and Lipoprotein Subfractions

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Sao Paulo, São Paulo, Other, Brazil

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phytosterol supplements

Dietary Supplement

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.

Primary outcomes

  1. Change in total and LDL-cholesterol

    Time frame: 12 weeks

    Phytosterol suplementation can reduce by 5-10% plasma levels of total- and LDL-cholesterol

Secondary outcomes

  1. Change in LDL subfractions

    Time frame: 12 weeks

    Phytosterol suplementation can modify LDL subfractions

  2. Change in HDL subfractions

    Time frame: 12 weeks

    Phytosterol suplementation can modify HDL subfractions

  3. Improvement on quality of LDL particle

    Time frame: 12 weeks

    Phytosterol supplementation can improve the quality of LDL particle

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Collaborators

  • University of Sao Paulo

Registry information

Official study title

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

Acronym: Phyto

Important dates

Study start
2017
Primary completion
2018
Study completion
2022
First posted
Nov 13, 2023
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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