Therapeutic Efficacy of Phytosterols on Metabolic Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-08

Study Completion Date

2018-11-27

Brief Summary

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

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Detailed Description

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Conditions

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Metabolic Syndrome x

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Phytosterol

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

Group Type EXPERIMENTAL

Phytosterols

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Titanium Dioxide

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Phytosterols

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

Intervention Type DIETARY_SUPPLEMENT

Titanium Dioxide

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Cardiosmile

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No