---
title: Therapeutic Efficacy of Phytosterols on Metabolic Syndrome
nct_id: NCT02969720
overall_status: COMPLETED
phase: NA
sponsor: Universidad de los Andes, Chile
study_type: INTERVENTIONAL
primary_condition: Metabolic Syndrome x
countries: Chile
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02969720.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02969720"
ct_last_update_post_date: 2020-03-17
last_seen_at: "2026-05-12T06:10:26.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Therapeutic Efficacy of Phytosterols on Metabolic Syndrome

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

**NCT ID:** [NCT02969720](https://clinicaltrials.gov/study/NCT02969720)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 220
- **Lead Sponsor:** Universidad de los Andes, Chile
- **Conditions:** Metabolic Syndrome x
- **Start Date:** 2018-01-08
- **Completion Date:** 2018-11-27
- **CT.gov Last Update:** 2020-03-17

## Brief Summary

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

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **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
```

## Arms

- **Phytosterol** (EXPERIMENTAL) — Daily consumption of 2 grams (8 ml) nano-phytosterols per 180 days.
- **Placebo** (PLACEBO_COMPARATOR) — Daily consumption of 8 ml of a solution with Titanium Dioxide per 180 days.

## Interventions

- **Phytosterols** (DIETARY_SUPPLEMENT) — Oral daily consumption of 2 grams of phytosterols (8 ml) per 180 days.
- **Titanium Dioxide** (DIETARY_SUPPLEMENT) — Oral daily consumption of Titanium Dioxide (8 ml) per 180 days.

## Primary Outcomes

- **Difference of proportion between study groups in the proportion of metabolic syndrome from baseline and the last visit (180 days).** _(time frame: 180 days)_

## Locations (1)

- Universidad de Los Andes, Santiago, Chile

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.universidad de los andes|santiago||chile` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02969720.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02969720*  
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