Metabolic SyndromeNCT02912325

Non-Comparative Study to Assess the Efficacy and Safety of the New Food Supplement FaseMETS

A study testing Daily administration: 2 tablets FaseMETS a day in people with Metabolic Syndrome, run by MDM S.p.A. at 2 sites in Romania.

Completed

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

Official record

Search all trials

Trial summary

The primary objective is to evaluate the efficacy of FaseMETS for 6 consecutive months in lowering serum lipids and glucose in subjects with Metabolic Syndrome; The secondary objectives of the trial are: to evaluate the potential benefit after 3 months of therapy (by an interim analysis) to evaluate the safety of… Read more about this study

Who is it for?: Ages 45 to 70 years
Conditions the study is for: Metabolic Syndrome
What is being tested?: Daily administration: 2 tablets FaseMETS a day
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: 2 sitesRomania
Study dates: 9 May 2017to 11 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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

men or women
age > 45 and ≤75 years
on cardiovascular disease prevention in clinical practice
written informed consent.
total cholesterol≥200 mg/dL
diagnosis of metabolic syndrome with three or more of the following:

Show all 11Show fewer

Waist circumference: ≥89 cm for women and ≥102 cm for men or BMI≥25 Kg/m2;
Triglycerides level: ≥ 175 mg/dL or 1.7 mmol/L
HDL <40 mg/dL (1.04 mmol/L) in men or <50 mg/dL (1.3 mmol/L) in women
Blood sugar (fasting plasma glucose): ≥120 mg/dL (6.7 mmol/L)
Elevated blood pressure: systolic ≥ 130 and/or diastolic ≥ 85 mm Hg (antihypertensive drug treatment in a patient with a history of hypertension is an alternate indicator).

Who cannot join

Pregnancy or lactation;
Patients at very high or low cardiovascular risk, having a calculated SCORE ≥10% or <1% respectively
History of atrial fibrillation or atrial flutter
Patient in treatment with indication to oral anticoagulants or other antithrombotic drugs
Patients with severe gastro-intestinal tract disorders with possible influence on drug absorption or electrolytes.
Patients with myeloproliferative disorders

Show all 14Show fewer

Patients with severe chronic kidney disease (GFR 30 mL/min/ 1.73 m2), using Cockcroft's formula, with known liver disease or biliary obstructive disorders, chronic hepatitis, cirrhosis, with hyperkalemia or with ALAT or ASAT upper than 3 times the upper limit of normal laboratory range.
History of alcoholism or drug abuse.
Uncontrolled dysthyroidism, Cushing's syndrome, acromegalia, hyperparathyroidism.
Patients with HIV or taking drugs for HIV.
Patients taking statins or other dyslipidemic /hypolipidemic agents (drugs, food supplements, etc).
Patients taking antidiabetic drugs (i.e metformin, acarbose and/or others).
Patients unlikely to co-operate in the study or to comply well with treatment or with the study visits.
Participation in another study at the same time or within the preceding 30 days.

Trial locations and contacts

2 sites in 1 country.

Romania2 sites

Opera Contract Research Organization SRL
Timișoara, Timiș County, 300209
Scm Dr Rosu
Timișoara, Timiș County, 300209

Other trials in Romania

About this study

Official title: A Pilot, Non-Comparative Study to Assess the Efficacy and Safety of the New Food Supplement FaseMETS in Metabolic Syndrome

The primary objective is to evaluate the efficacy of FaseMETS for 6 consecutive months in lowering serum lipids and glucose in subjects with Metabolic Syndrome;

The secondary objectives of the trial are:

to evaluate the potential benefit after 3 months of therapy (by an interim analysis)
to evaluate the safety of FaseMETS

Read the detailed description

The trial is designed as a multicenter, open label, non-comparative, 6 months, pilot study.

The primary objective is to evaluate the efficacy of FaseMetS ® administered for 6 months treatment combined with a health management plan in reducing the serum lipidemic profile (this includes total cholesterol, LDL cholesterol, HDL cholesterol, small density LDL particles, triglycerides, serum glucose, glycated haemoglobin (HBA1c), insulin, and pro-insulin, HOMA index, uric acid, body mass index (BMI), creatine phosphokinase) in patients diagnosed with Metabolic Syndrome and with mild to moderate Hypercholesterolemia.

The secondary objectives are:

to evaluate the efficacy in reducing the serum lipidemic profile after a period of 3 months of FaseMetS ® ® treatment;
to evaluate the safety of FaseMetS ® treatment by recording AE/SAE (with particular regards for gastrointestinal symptoms);
improvement of blood clinical laboratory parameters;
improvement of weight control systolic blood pressure and diastolic blood pressure control

Conditions: Metabolic Syndrome
Being tested: Daily administration: 2 tablets FaseMETS a day
Medical subject headings: Metabolic Syndrome

What participants receive

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

Daily administration: 2 tablets FaseMETS a dayDietary supplement
Treatment with FaseMETS for 6 consecutive months in lowering serum lipids and glucose in subjects with Metabolic Syndrome

Study groups in NCT02912325
Study group	Role	What they receive
FaseMetS ® a food supplement	Other	Daily administration: 2 tablets FaseMETS a day Receives: Dietary Supplement: Daily administration: 2 tablets FaseMETS a day

What is being measured

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

Serum lipidemic profile evaluated at 6 months
laboratory test
Measured: 6 months

Secondary outcomes (2)

Serum lipidemic profile evaluated at 3 months
laboratory test
Measured: 3 months
AE/SAE (with particular regards for gastrointestinal symptoms)
- blood clinical laboratory parameters
- physical examination including weight, systolic blood pressure and diastolic blood pressure
Measured: 6 months

Timeline

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

9 May 201711 Jun 2018

First posted23 Sep 2016 (estimated)
Study start9 May 2017
Primary completion15 Oct 2017
Study completion11 Jun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (18)Papers the sponsor has linked to this study.
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: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02912325
Sponsor's protocol ID: OPMDM/0216/FS
Status last verified: Sep 2019
First submitted: 12 Sep 2016
Last updated: 1 Oct 2019
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Gielen S, Sandri M, Schuler G, Teupser D. Risk factor management: antiatherogenic therapies. Eur J Cardiovasc Prev Rehabil. 2009 Aug;16 Suppl 2:S29-36. doi: 10.1097/01.hjr.0000359233.58023.64.
PubMed 19675434
Lorenzo C, Wagenknecht LE, D'Agostino RB Jr, Rewers MJ, Karter AJ, Haffner SM. Insulin resistance, beta-cell dysfunction, and conversion to type 2 diabetes in a multiethnic population: the Insulin Resistance Atherosclerosis Study. Diabetes Care. 2010 Jan;33(1):67-72. doi: 10.2337/dc09-1115. Epub 2009 Oct 6.
PubMed 19808919
Baigent C, Keech A, Kearney PM, Blackwell L, Buck G, Pollicino C, Kirby A, Sourjina T, Peto R, Collins R, Simes R; Cholesterol Treatment Trialists' (CTT) Collaborators. Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90,056 participants in 14 randomised trials of statins. Lancet. 2005 Oct 8;366(9493):1267-78. doi: 10.1016/S0140-6736(05)67394-1. Epub 2005 Sep 27.
PubMed 16214597
Cannon CP, Steinberg BA, Murphy SA, Mega JL, Braunwald E. Meta-analysis of cardiovascular outcomes trials comparing intensive versus moderate statin therapy. J Am Coll Cardiol. 2006 Aug 1;48(3):438-45. doi: 10.1016/j.jacc.2006.04.070. Epub 2006 Jul 12.
PubMed 16875966
Alsheikh-Ali AA, Karas RH. The relationship of statins to rhabdomyolysis, malignancy, and hepatic toxicity: evidence from clinical trials. Curr Atheroscler Rep. 2009 Mar;11(2):100-4. doi: 10.1007/s11883-009-0016-8.
PubMed 19228482
Joy TR, Hegele RA. Narrative review: statin-related myopathy. Ann Intern Med. 2009 Jun 16;150(12):858-68. doi: 10.7326/0003-4819-150-12-200906160-00009.
PubMed 19528564
Rondanelli M, Giacosa A, Orsini F, Opizzi A, Villani S. Appetite control and glycaemia reduction in overweight subjects treated with a combination of two highly standardized extracts from Phaseolus vulgaris and Cynara scolymus. Phytother Res. 2011 Sep;25(9):1275-82. doi: 10.1002/ptr.3425. Epub 2011 Feb 10.
PubMed 21308825
Luzzi R, Belcaro G, Hu S, Dugall M, Hosoi M, Ippolito E, Corsi M, Gizzi G. Beanblock(R) (standardized dry extract of Phaseolus vulgaris) in mildly overweight subjects: a pilot study. Eur Rev Med Pharmacol Sci. 2014 Oct;18(20):3120-5.
PubMed 25392114
Bunnoy A, Saenphet K, Lumyong S, Saenphet S, Chomdej S. Monascus purpureus-fermented Thai glutinous rice reduces blood and hepatic cholesterol and hepatic steatosis concentrations in diet-induced hypercholesterolemic rats. BMC Complement Altern Med. 2015 Mar 28;15:88. doi: 10.1186/s12906-015-0624-5.
PubMed 25880551
Matthews DR, Hosker JP, Rudenski AS, Naylor BA, Treacher DF, Turner RC. Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia. 1985 Jul;28(7):412-9. doi: 10.1007/BF00280883.
PubMed 3899825
Oh HG, Kang YR, Lee HY, Kim JH, Shin EH, Lee BG, Park SH, Moon DI, Kim OJ, Lee IA, Choi J, Lee JE, Park KH, Suh JW. Ameliorative effects of Monascus pilosus-fermented black soybean (Glycine max L. Merrill) on high-fat diet-induced obesity. J Med Food. 2014 Sep;17(9):972-8. doi: 10.1089/jmf.2012.2740. Epub 2014 Aug 12.
PubMed 25115132
Cicero AF, Morbini M, Rosticci M, D''Addato S, Grandi E, Borghi C. Middle-Term Dietary Supplementation with Red Yeast Rice Plus Coenzyme Q10 Improves Lipid Pattern, Endothelial Reactivity and Arterial Stiffness in Moderately Hypercholesterolemic Subjects. Ann Nutr Metab. 2016;68(3):213-9. doi: 10.1159/000445359. Epub 2016 Apr 8.
PubMed 27055107
Patel S. Functional food red yeast rice (RYR) for metabolic syndrome amelioration: a review on pros and cons. World J Microbiol Biotechnol. 2016 May;32(5):87. doi: 10.1007/s11274-016-2035-2. Epub 2016 Apr 2.
PubMed 27038957
McCarty MF, O'Keefe JH, DiNicolantonio JJ. Red Yeast Rice Plus Berberine: Practical Strategy for Promoting Vascular and Metabolic Health. Altern Ther Health Med. 2015;21 Suppl 2:40-5.
PubMed 26308759
Burke FM. Red yeast rice for the treatment of dyslipidemia. Curr Atheroscler Rep. 2015 Apr;17(4):495. doi: 10.1007/s11883-015-0495-8.
PubMed 25728312

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?

See locations

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All Metabolic Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot, Non-Comparative Study to Assess the Efficacy and Safety of the New Food Supplement FaseMETS in Metabolic Syndrome
ClinicalTrials.gov ID: NCT02912325
Acronym / sponsor ID: OPMDM/0216/FS
Conditions: Metabolic Syndrome
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: MDM S.p.A.University, hospital or other
Collaborators: Opera CRO, a TIGERMED Group Company
Study start: 9 May 2017 (actual)
Primary completion: 15 Oct 2017 (actual)
Study completion: 11 Jun 2018 (actual)
First posted: 23 Sep 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 primary objective is to evaluate the efficacy of FaseMETS for 6 consecutive months in lowering serum lipids and glucose in subjects with Metabolic Syndrome;

The secondary objectives of the trial are:

to evaluate the potential benefit after 3 months of therapy (by an interim analysis)
to evaluate the safety of FaseMETS

Detailed description

The trial is designed as a multicenter, open label, non-comparative, 6 months, pilot study.

The secondary objectives are:

to evaluate the efficacy in reducing the serum lipidemic profile after a period of 3 months of FaseMetS ® ® treatment;
to evaluate the safety of FaseMetS ® treatment by recording AE/SAE (with particular regards for gastrointestinal symptoms);
improvement of blood clinical laboratory parameters;
improvement of weight control systolic blood pressure and diastolic blood pressure control

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
FaseMetS ® a food supplement	Other	Dietary Supplement: Daily administration: 2 tablets FaseMETS a dayDaily administration: 2 tablets FaseMETS a day

Who may qualify

Ages: 45 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

men or women
age > 45 and ≤75 years
on cardiovascular disease prevention in clinical practice
written informed consent.
total cholesterol≥200 mg/dL

Key exclusion criteria (14 listed)

Pregnancy or lactation;
Patients at very high or low cardiovascular risk, having a calculated SCORE ≥10% or <1% respectively
History of atrial fibrillation or atrial flutter
Patient in treatment with indication to oral anticoagulants or other antithrombotic drugs
Patients with severe gastro-intestinal tract disorders with possible influence on drug absorption or electrolytes.

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
Daily administration: 2 tablets FaseMETS a dayTreatment with FaseMETS for 6 consecutive months in lowering serum lipids and glucose in subjects with Metabolic Syndrome	Dietary supplement	FaseMetS ® a food supplement

Primary outcome

Serum lipidemic profile evaluated at 6 months
Time frame: 6 months
laboratory test

2 secondary outcomes

Serum lipidemic profile evaluated at 3 months
Time frame: 3 months
AE/SAE (with particular regards for gastrointestinal symptoms)
Time frame: 6 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 1 Oct 2019.
Background: PubMed 19675434Gielen S, Sandri M, Schuler G, Teupser D. Risk factor management: antiatherogenic therapies. Eur J Cardiovasc Prev Rehabil. 2009 Aug;16 Suppl 2:S29-36. doi: 10.1097/01.hjr.0000359233.58023.64.
Background: PubMed 19808919Lorenzo C, Wagenknecht LE, D'Agostino RB Jr, Rewers MJ, Karter AJ, Haffner SM. Insulin resistance, beta-cell dysfunction, and conversion to type 2 diabetes in a multiethnic population: the Insulin Resistance Atherosclerosis Study. Diabetes Care. 2010 Jan;33(1):67-72. doi: 10.2337/dc09-1115. Epub 2009 Oct 6.
Background: PubMed 16214597Baigent C, Keech A, Kearney PM, Blackwell L, Buck G, Pollicino C, Kirby A, Sourjina T, Peto R, Collins R, Simes R; Cholesterol Treatment Trialists' (CTT) Collaborators. Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90,056 participants in 14 randomised trials of statins. Lancet. 2005 Oct 8;366(9493):1267-78. doi: 10.1016/S0140-6736(05)67394-1. Epub 2005 Sep 27.
Background: PubMed 16875966Cannon CP, Steinberg BA, Murphy SA, Mega JL, Braunwald E. Meta-analysis of cardiovascular outcomes trials comparing intensive versus moderate statin therapy. J Am Coll Cardiol. 2006 Aug 1;48(3):438-45. doi: 10.1016/j.jacc.2006.04.070. Epub 2006 Jul 12.
Background: PubMed 19228482Alsheikh-Ali AA, Karas RH. The relationship of statins to rhabdomyolysis, malignancy, and hepatic toxicity: evidence from clinical trials. Curr Atheroscler Rep. 2009 Mar;11(2):100-4. doi: 10.1007/s11883-009-0016-8.
Background: PubMed 19528564Joy TR, Hegele RA. Narrative review: statin-related myopathy. Ann Intern Med. 2009 Jun 16;150(12):858-68. doi: 10.7326/0003-4819-150-12-200906160-00009.
Background: PubMed 21308825Rondanelli M, Giacosa A, Orsini F, Opizzi A, Villani S. Appetite control and glycaemia reduction in overweight subjects treated with a combination of two highly standardized extracts from Phaseolus vulgaris and Cynara scolymus. Phytother Res. 2011 Sep;25(9):1275-82. doi: 10.1002/ptr.3425. Epub 2011 Feb 10.
Background: PubMed 25392114Luzzi R, Belcaro G, Hu S, Dugall M, Hosoi M, Ippolito E, Corsi M, Gizzi G. Beanblock(R) (standardized dry extract of Phaseolus vulgaris) in mildly overweight subjects: a pilot study. Eur Rev Med Pharmacol Sci. 2014 Oct;18(20):3120-5.
Background: PubMed 25880551Bunnoy A, Saenphet K, Lumyong S, Saenphet S, Chomdej S. Monascus purpureus-fermented Thai glutinous rice reduces blood and hepatic cholesterol and hepatic steatosis concentrations in diet-induced hypercholesterolemic rats. BMC Complement Altern Med. 2015 Mar 28;15:88. doi: 10.1186/s12906-015-0624-5.
Background: PubMed 3899825Matthews DR, Hosker JP, Rudenski AS, Naylor BA, Treacher DF, Turner RC. Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man. Diabetologia. 1985 Jul;28(7):412-9. doi: 10.1007/BF00280883.
Background: PubMed 25115132Oh HG, Kang YR, Lee HY, Kim JH, Shin EH, Lee BG, Park SH, Moon DI, Kim OJ, Lee IA, Choi J, Lee JE, Park KH, Suh JW. Ameliorative effects of Monascus pilosus-fermented black soybean (Glycine max L. Merrill) on high-fat diet-induced obesity. J Med Food. 2014 Sep;17(9):972-8. doi: 10.1089/jmf.2012.2740. Epub 2014 Aug 12.
Background: PubMed 27055107Cicero AF, Morbini M, Rosticci M, D''Addato S, Grandi E, Borghi C. Middle-Term Dietary Supplementation with Red Yeast Rice Plus Coenzyme Q10 Improves Lipid Pattern, Endothelial Reactivity and Arterial Stiffness in Moderately Hypercholesterolemic Subjects. Ann Nutr Metab. 2016;68(3):213-9. doi: 10.1159/000445359. Epub 2016 Apr 8.
Individual participant dataSharing planned: No

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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.

Antonio Maggi, MD study director

MDM SpA Italy

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Daily administration: 2 tablets FaseMETS a day in people with Metabolic Syndrome, run by MDM S.p.A. at 2 sites in Romania.

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 11 inclusion and 14 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 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Romania. 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. 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?

Serum lipidemic profile evaluated at 6 months (time frame: 6 months). 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 NCT02912325, which also lists 18 linked publications.

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 1 Oct 2019.