Therapeutic Efficacy of Phytosterols on Metabolic Syndrome

Overview

The objective is to evaluate therapeutic efficacy of 2 grams nano-phytosterols daily supplemention on diagnosis criteria of metabolic syndrome.

Full Title of Study: “Double Blind, Randomized, Phase III, Parallel, Placebo-controled Study to Evaluate Therapeutic Efficacy of 2 Grams Phytosterols Daily Supplemention on Patients With Metabolic Syndrome”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: November 27, 2018

Interventions

  • Dietary Supplement: Phytosterols
    • Oral daily consumption of 2 grams of phytosterols (8 ml) per 180 days.
  • Dietary Supplement: Titanium Dioxide
    • Oral daily consumption of Titanium Dioxide (8 ml) per 180 days.

Arms, Groups and Cohorts

  • Experimental: Phytosterol
    • Daily consumption of 2 grams (8 ml) nano-phytosterols per 180 days.
  • Placebo Comparator: Placebo
    • Daily consumption of 8 ml of a solution with Titanium Dioxide per 180 days.

Clinical Trial Outcome Measures

Primary Measures

  • Difference of proportion between study groups in the proportion of metabolic syndrome from baseline and the last visit (180 days).
    • Time Frame: 180 days

Participating in This Clinical Trial

Inclusion Criteria

  • Informed consent written – Available subjects to follow-up visits – Subjects with diagnoses of metabolic syndrome 5 years ago or with current diagnoses criteria – Subjects with health visits ongoing – Subjects with arterial hypertension under control. – Subjects with mellitus diabetes under control. Exclusion Criteria:

  • Subjects with alcoholism history. – Subjects with history of sitosterolemia. – Subjects with familiar hypercholesterolemia – Subjects who are consuming phytosterols – Pregnancy women – Breastfeeding period women – Subjects with personal history of: acute miocardical infarction, stroke, hypertensive emergency, acute or chronic diabetes descompensation

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Universidad de los Andes, Chile
  • Provider of Information About this Clinical Study
    • Principal Investigator: Yasna Palmeiro-Silva, Asistant Professor – Universidad de los Andes, Chile

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