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Therapeutic Efficacy of Phytosterols on Metabolic Syndrome

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02969720
Acronym
FESIME
Enrollment
220
Registered
2016-11-21
Start date
2018-01-08
Completion date
2018-11-27
Last updated
2020-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome x

Brief summary

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

Interventions

DIETARY_SUPPLEMENTPhytosterols

Oral daily consumption of 2 grams of phytosterols (8 ml) per 180 days.

DIETARY_SUPPLEMENTTitanium Dioxide

Oral daily consumption of Titanium Dioxide (8 ml) per 180 days.

Sponsors

Universidad de los Andes, Chile
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026