search
Back to results

Therapeutic Efficacy of Phytosterols on Metabolic Syndrome (FESIME)

Primary Purpose

Metabolic Syndrome x

Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Phytosterols
Titanium Dioxide
Sponsored by
Universidad de los Andes, Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome x

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universidad de Los Andes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Phytosterol

Placebo

Arm Description

Daily consumption of 2 grams (8 ml) nano-phytosterols per 180 days.

Daily consumption of 8 ml of a solution with Titanium Dioxide per 180 days.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 17, 2016
Last Updated
March 14, 2020
Sponsor
Universidad de los Andes, Chile
search

1. Study Identification

Unique Protocol Identification Number
NCT02969720
Brief Title
Therapeutic Efficacy of Phytosterols on Metabolic Syndrome
Acronym
FESIME
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
January 8, 2018 (Actual)
Primary Completion Date
November 27, 2018 (Actual)
Study Completion Date
November 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de los Andes, Chile

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome x

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phytosterol
Arm Type
Experimental
Arm Description
Daily consumption of 2 grams (8 ml) nano-phytosterols per 180 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Daily consumption of 8 ml of a solution with Titanium Dioxide per 180 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
Phytosterols
Other Intervention Name(s)
Cardiosmile
Intervention Description
Oral daily consumption of 2 grams of phytosterols (8 ml) per 180 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
Titanium Dioxide
Intervention Description
Oral daily consumption of Titanium Dioxide (8 ml) per 180 days.
Primary Outcome Measure Information:
Title
Difference of proportion between study groups in the proportion of metabolic syndrome from baseline and the last visit (180 days).
Time Frame
180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Universidad de Los Andes
City
Santiago
Country
Chile

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
PI will share IPD after doing all possible publications.
Citations:
PubMed Identifier
32785036
Citation
Palmeiro-Silva YK, Aravena RI, Ossio L, Parro Fluxa J. Effects of Daily Consumption of an Aqueous Dispersion of Free-Phytosterols Nanoparticles on Individuals with Metabolic Syndrome: A Randomised, Double-Blind, Placebo-Controlled Clinical Trial. Nutrients. 2020 Aug 10;12(8):2392. doi: 10.3390/nu12082392.
Results Reference
derived

Learn more about this trial

Therapeutic Efficacy of Phytosterols on Metabolic Syndrome

We'll reach out to this number within 24 hrs