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OpenTrials
Completed

NCT Number: NCT02969720

Therapeutic Efficacy of Phytosterols on Metabolic Syndrome

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

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Key information

Conditions

Metabolic Syndrome X Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de Los Andes

Santiago, Chile

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phytosterols

Dietary Supplement

Oral daily consumption of 2 grams of phytosterols (8 ml) per 180 days.

Other names: Cardiosmile

Titanium Dioxide

Dietary Supplement

Oral daily consumption of Titanium Dioxide (8 ml) per 180 days.

Primary outcomes

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

    Time frame: 180 days

Sponsors and collaborators

Lead sponsor

Universidad de los Andes, Chile

Other

Registry information

Official study title

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

Acronym: FESIME

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 21, 2016
Registry last updated
Mar 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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