Therapeutic Efficacy of Phytosterols on Metabolic Syndrome (FESIME)

Universidad de los Andes, Chile

Status: Completed

Conditions: Metabolic Syndrome x

Treatments: Dietary Supplement: Titanium Dioxide; Dietary Supplement: Phytosterols

Study type: Interventional

Funder types: Other

Identifiers

NCT02969720

FESIME-016

Details and patient eligibility

About

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

Enrollment: 220 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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220 participants in 2 patient groups, including a placebo group

Phytosterol

Experimental group

Description:

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

Treatment:

Dietary Supplement: Phytosterols

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Titanium Dioxide