Therapeutic Efficacy of Phytosterols on Metabolic Syndrome

Not Applicable

Completed

• Conditions: Metabolic Syndrome x
• Interventions: Dietary Supplement: Phytosterols; Dietary Supplement: Titanium Dioxide

• Registration Number: NCT02969720
• Lead Sponsor: Universidad de los Andes, Chile

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-17
• Study First Submitted QC: 2016-11-17
• Study First Posted: 2016-11-21
• Study Start: 2018-01-08
• Primary Completion: 2018-11-27
• Study Completion: 2018-11-27
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-14
• Last Update Posted: 2020-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phytosterol	Phytosterols	Daily consumption of 2 grams (8 ml) nano-phytosterols per 180 days.
Placebo	Titanium Dioxide	Daily consumption of 8 ml of a solution with Titanium Dioxide per 180 days.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Universidad de Los Andes; 🇨🇱 Santiago, Chile