Phytosterol Supplementation and Lipoprotein Subfractions

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Hypercholesterolemia, Primary Prevention

Intervention / Treatment
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* Dietary Supplement: Phytosterol supplements


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, open-label, crossover intervention study conducted with participants selected by the investigators, and invited to participate in the study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phytosterol<br>Participants received diet plus phytosterols (2.6 g of phytosterols per day) prescribed and supplied in 650 mg gelatin capsules, to be used four capsules a day along with meals(Fitocor®, Farmoquímica, Brazil) and divided into two meals.for 12 weeks. | Dietary Supplement: Phytosterol supplements<br>* 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.<br>|
| No Intervention: Control: diet alone<br>Participants received diet alone recommended for 12 weeks. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in total and LDL-cholesterol | Phytosterol suplementation can reduce by 5-10% plasma levels of total- and LDL-cholesterol | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in LDL subfractions | Phytosterol suplementation can modify LDL subfractions | 12 weeks | 
| Change in HDL subfractions | Phytosterol suplementation can modify HDL subfractions | 12 weeks | 
| Improvement on quality of LDL particle | Phytosterol supplementation can improve the quality of LDL particle | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phytosterols, Lipoproteins, LDL-subfractions, HDL-subfractions