Therapeutic Efficacy of Phytosterols on Metabolic Syndrome (FESIME)

March 14, 2020 updated by: Yasna Palmeiro-Silva, Universidad de los Andes, Chile

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
      • Santiago, Chile
        • Universidad de Los Andes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phytosterol
Daily consumption of 2 grams (8 ml) nano-phytosterols per 180 days.
Dietary supplement: Phytosterols
Oral daily consumption of 2 grams of phytosterols (8 ml) per 180 days.
Other Names:
  • Cardiosmile
Placebo Comparator: Placebo
Daily consumption of 8 ml of a solution with Titanium Dioxide per 180 days.
Dietary supplement: Titanium Dioxide
Oral daily consumption of Titanium Dioxide (8 ml) per 180 days.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de los Andes, Chile

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2018

Primary Completion (Actual)

November 27, 2018

Study Completion (Actual)

November 27, 2018

Study Registration Dates

First Submitted

November 17, 2016

First Submitted That Met QC Criteria

November 17, 2016

First Posted (Estimate)

November 21, 2016

Study Record Updates

Last Update Posted (Actual)

March 17, 2020

Last Update Submitted That Met QC Criteria

March 14, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FESIME-016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

PI will share IPD after doing all possible publications.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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