NCT06127732

Phytosterol Supplementation and Lipoprotein Subfractions

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Federal University of São Paulo · Academic / Other
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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).

Conditions

• Hypercholesterolemia
• Primary Prevention

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-05-01
• Primary completion: 2018-09-30
• Completion: 2022-01-10
• First posted: 2023-11-13
• Last updated: 2023-11-13

Locations

2 sites across 1 country: Brazil