Metabolic Syndrome xFESIMENCT02969720
Therapeutic Efficacy of Phytosterols on Metabolic Syndrome
A study testing Phytosterols and Titanium Dioxide in people with Metabolic Syndrome x, run by Universidad de los Andes, Chile at 1 site in Chile.
Trial summary
The objective is to evaluate therapeutic efficacy of 2 grams nano-phytosterols daily supplemention on diagnosis criteria of metabolic syndrome. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Metabolic Syndrome x
- What is being tested?
- Phytosterols and Titanium Dioxide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 siteChile
- Study dates
- 8 Jan 2018to 27 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
The objective is to evaluate therapeutic efficacy of 2 grams nano-phytosterols daily supplemention on diagnosis criteria of metabolic syndrome.
- Conditions
- Metabolic Syndrome x
- Being tested
- Phytosterols, Titanium Dioxide
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhytosterolsDietary supplement
Also called Cardiosmile
Oral daily consumption of 2 grams of phytosterols (8 ml) per 180 days.
Titanium DioxideDietary supplement
Oral daily consumption of Titanium Dioxide (8 ml) per 180 days.
| Study group | Role | What they receive |
|---|---|---|
| Phytosterol | Experimental | Daily consumption of 2 grams (8 ml) nano-phytosterols per 180 days. Receives: Dietary Supplement: Phytosterols |
| Placebo | Placebo comparator | Daily consumption of 8 ml of a solution with Titanium Dioxide per 180 days. Receives: Dietary Supplement: Titanium Dioxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of proportion between study groups in the proportion of metabolic syndrome from baseline and the last visit (180 days).
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study start8 Jan 2018
- Primary completion27 Nov 2018
- Study completion27 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic Syndrome xStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de los Andes, Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasna Palmeiro-Silva, Universidad de los Andes, Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02969720
- Sponsor's protocol ID
- FESIME-016
- Acronym
- FESIME
- Status last verified
- Mar 2020
- First submitted
- 17 Nov 2016
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: PI will share IPD after doing all possible publications.
Publications
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.
PubMed 32785036
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02969720
- Acronym / sponsor ID
- FESIME / FESIME-016
- Conditions
- Metabolic Syndrome x
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Universidad de los Andes, ChileUniversity, hospital or other
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 27 Nov 2018 (actual)
- Study completion
- 27 Nov 2018 (actual)
- First posted
- 21 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective is to evaluate therapeutic efficacy of 2 grams nano-phytosterols daily supplemention on diagnosis criteria of metabolic syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phytosterol | Experimental | Dietary Supplement: PhytosterolsDaily consumption of 2 grams (8 ml) nano-phytosterols per 180 days. |
| Placebo | Placebo comparator | Dietary Supplement: Titanium DioxideDaily consumption of 8 ml of a solution with Titanium Dioxide per 180 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- Subjects with alcoholism history.
- Subjects with history of sitosterolemia.
- Subjects with familiar hypercholesterolemia
- Subjects who are consuming phytosterols
- Pregnancy women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhytosterolsAlso: CardiosmileOral daily consumption of 2 grams of phytosterols (8 ml) per 180 days. | Dietary supplement | Phytosterol |
| Titanium DioxideOral daily consumption of Titanium Dioxide (8 ml) per 180 days. | Dietary supplement | Placebo |
Primary outcome
Difference of proportion between study groups in the proportion of metabolic syndrome from baseline and the last visit (180 days).
Time frame: 180 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Derived from this study: PubMed 32785036Palmeiro-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.
- Individual participant dataSharing planned: Undecided. PI will share IPD after doing all possible publications.
Related trials for Metabolic Syndrome x
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phytosterols and Titanium Dioxide in people with Metabolic Syndrome x, run by Universidad de los Andes, Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of proportion between study groups in the proportion of metabolic syndrome from baseline and the last visit (180 days). (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02969720, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.