Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-24 @ 9:56 PM
NCT ID:
NCT06127732
Brief 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).
Study:
NCT06127732
Study Brief:
Protocol Section:
NCT06127732