Therapeutic Efficacy of Phytosterols on Metabolic Syndrome
FESIME
Double Blind, Randomized, Phase III, Parallel, Placebo-controled Study to Evaluate Therapeutic Efficacy of 2 Grams Phytosterols Daily Supplemention on Patients With Metabolic Syndrome
1 other identifier
interventional
220
1 country
1
Brief Summary
The objective is to evaluate therapeutic efficacy of 2 grams nano-phytosterols daily supplemention on diagnosis criteria of metabolic syndrome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2016
CompletedFirst Posted
Study publicly available on registry
November 21, 2016
CompletedStudy Start
First participant enrolled
January 8, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 27, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 27, 2018
CompletedMarch 17, 2020
March 1, 2020
11 months
November 17, 2016
March 14, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Difference of proportion between study groups in the proportion of metabolic syndrome from baseline and the last visit (180 days).
180 days
Study Arms (2)
Phytosterol
EXPERIMENTALDaily consumption of 2 grams (8 ml) nano-phytosterols per 180 days.
Placebo
PLACEBO COMPARATORDaily consumption of 8 ml of a solution with Titanium Dioxide per 180 days.
Interventions
Oral daily consumption of 2 grams of phytosterols (8 ml) per 180 days.
Oral daily consumption of Titanium Dioxide (8 ml) per 180 days.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universidad de Los Andes
Santiago, Chile
Related Publications (1)
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.
PMID: 32785036DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Asistant Professor
Study Record Dates
First Submitted
November 17, 2016
First Posted
November 21, 2016
Study Start
January 8, 2018
Primary Completion
November 27, 2018
Study Completion
November 27, 2018
Last Updated
March 17, 2020
Record last verified: 2020-03