A New Supplement for the "Metabolic Syndrome"

A study testing Sineos in people with Metabolic Syndrome, run by University of Messina.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study evaluates the effect of a combination of glycirrhizic acid, Cinnamomun Zeylanicum and corosolic acid for the treatment of metabolic syndrome. Participants receive the supplement or a placebo. Read more about this study

Who is it for?: Ages 45 to 65 years, women only
Conditions the study is for: Metabolic Syndrome
What is being tested?: Sineos
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: No sites listed yet
Study dates: 15 Jan 2017to 30 Jun 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 45 to 65 years
Women only
No healthy volunteers
Adult, Older adult

Inclusion Criteria: Postmenopausal women affected by Metabolic Syndrome, diagnosed by ATP 2015 criteria.

Exclusion Criteria: treatment with steroids or with hypoglycemic or anti-cholesterol drugs

About this study

Official title: Corosolic Acid and Cinnamon for the Treatment of the "Metabolic Syndrome" in Menopausal Transition Women

Read the detailed description

The supplement is composed by of a combination of glycirrhizic acid, Cinnamomun Zeylanicum and corosolic acid. They act in different way reducing insulin resistance, which is the main cause of metabolic syndrome. It was a randomized, controlled study involving 60 women with the metabolic syndrome following the criteria proposed by ATP III in 2015. Main outcomes were the improvement of the parameters that characterizes the metabolic syndrome, such as glucose and insulin levels, triglycerides, HDL-cholesterol and blood pressure.

Conditions: Metabolic Syndrome
Being tested: Sineos
Keywords: insulin resistance, blood pressure,
Medical subject headings: Metabolic Syndrome, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SineosDietary supplement
glycyrrhizic acid 38 mg + Cinnamomum Zeylanicum 150 mg + corosolic acid 480 mcg 2 pills per day

Study groups in NCT03813914
Study group	Role	What they receive
Sineos	Experimental	Glycyrrhizic acid 38 mg + Cinnamomum Zeylanicum 150 mg + corosolic acid 480 mcg 2 pills/day for 3 months Receives: Dietary Supplement: Sineos
Placebo comparator	Placebo comparator	placebo 2 pills/day for 3 months Receives: Dietary Supplement: Sineos

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in glycemia
Reduction of glycemia (mg/dl)
Measured: 3 months
Changes in HDL-cholesterol
Increase of HDL-C (mg/dl)
Measured: 3 months

Secondary outcomes (3)

changes in HOMA-IR
measured as the ratio between glycaemia (mg/dl) and insulin (UI)
Measured: 3 months
changes in total-cholesterol
reduction of cholesterol (mg/dl)
Measured: 3 months
changes in triglycerides
reduction in triglycerides (mg/dl)
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jan 201730 Jun 2018

First posted23 Jan 2019
Study start15 Jan 2017
Primary completion15 Jan 2018
Study completion30 Jun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Metabolic SyndromeStudies 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: Single blind
Who is masked: Participant
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03813914
Sponsor's protocol ID: Sineos-3
Status last verified: Jan 2019
First submitted: 7 Aug 2018
Last updated: 23 Jan 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
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Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
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Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy

All Metabolic Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Corosolic Acid and Cinnamon for the Treatment of the "Metabolic Syndrome" in Menopausal Transition Women
ClinicalTrials.gov ID: NCT03813914
Acronym / sponsor ID: Sineos-3
Conditions: Metabolic Syndrome
Keywords: insulin resistance, blood pressure,
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: University of MessinaUniversity, hospital or other
Study start: 15 Jan 2017 (actual)
Primary completion: 15 Jan 2018 (actual)
Study completion: 30 Jun 2018 (actual)
First posted: 23 Jan 2019 (actual)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Sineos	Experimental	Dietary Supplement: SineosGlycyrrhizic acid 38 mg + Cinnamomum Zeylanicum 150 mg + corosolic acid 480 mcg 2 pills/day for 3 months
Placebo comparator	Placebo comparator	Dietary Supplement: Sineosplacebo 2 pills/day for 3 months

Who may qualify

Ages: 45 to 65 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

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
Sineosglycyrrhizic acid 38 mg + Cinnamomum Zeylanicum 150 mg + corosolic acid 480 mcg 2 pills per day	Dietary supplement	Placebo comparator, Sineos

Primary outcome

Changes in glycemia
Time frame: 3 months
Reduction of glycemia (mg/dl)
Changes in HDL-cholesterol
Time frame: 3 months
Increase of HDL-C (mg/dl)

3 secondary outcomes

changes in HOMA-IR
Time frame: 3 months
changes in total-cholesterol
Time frame: 3 months
changes in triglycerides
Time frame: 3 months

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 23 Jan 2019.
Individual participant dataSharing planned: No

Related trials for Metabolic Syndrome

RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Not yet recruitingPhase 2
Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy

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.

Questions about this trial

What is this clinical trial studying?

A study testing Sineos in people with Metabolic Syndrome, run by University of Messina.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

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?

Changes in glycemia (time frame: 3 months). The study lists 2 primary outcomes in all. 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 NCT03813914.

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 23 Jan 2019.