Therapeutic Efficacy of Phytosterols on Metabolic Syndrome

Metabolic Syndrome x Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02969720
• Other study ID #: FESIME-016
• Status: Completed
• Phase: N/A
• Start date: January 8, 2018
• Est. completion date: November 27, 2018

Study information

• Verified date: March 2020
• Source: Universidad de los Andes, Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: November 27, 2018
• Est. primary completion date: November 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome x
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Chile	Universidad de Los Andes	Santiago

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de los Andes, Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference of proportion between study groups in the proportion of metabolic syndrome from baseline and the last visit (180 days).		180 days