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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
23
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.
University of Sao Paulo
São Paulo, Other, Brazil
Federal University of Sao Paulo
São Paulo, São Paulo, Brazil
Change in total and LDL-cholesterol
Phytosterol suplementation can reduce by 5-10% plasma levels of total- and LDL-cholesterol
Time frame: 12 weeks
Change in LDL subfractions
Phytosterol suplementation can modify LDL subfractions
Time frame: 12 weeks
Change in HDL subfractions
Phytosterol suplementation can modify HDL subfractions
Time frame: 12 weeks
Improvement on quality of LDL particle
Phytosterol supplementation can improve the quality of LDL particle
Time frame: 12 weeks
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