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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02912325
• Other study ID #: OPMDM/0216/FS
• Status: Completed
• Phase: N/A
• Start date: May 9, 2017
• Est. completion date: June 11, 2018

Study information

• Verified date: September 2019
• Source: MDM S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 FaseMETS

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 11, 2018
• Est. primary completion date: October 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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:

• 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).

Exclusion Criteria:

• 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

• 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.

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

Intervention

Dietary Supplement:
• Daily administration: 2 tablets FaseMETS a day
Treatment with FaseMETS for 6 consecutive months in lowering serum lipids and glucose in subjects with Metabolic Syndrome

Locations

Country	Name	City	State
Romania	Opera Contract Research Organization SRL	Timisoara	Timis
Romania	Scm Dr Rosu	Timisoara	Timis

Sponsors (2)

Lead Sponsor	Collaborator
MDM S.p.A.	Opera CRO, a TIGERMED Group Company

Country where clinical trial is conducted

Romania, 

References & Publications (18)

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. Review. — View Citation

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. Epub 2005 Sep 27. Erratum in: Lancet. 2005 Oct 15-21;366(9494):1358. Lancet. 2008 Jun 21;371(9630):2084. — View Citation

Bhatnagar D, Soran H, Durrington PN. Hypercholesterolaemia and its management. BMJ. 2008 Aug 21;337:a993. doi: 10.1136/bmj.a993. Review. — View Citation

Brown P, Brunnhuber K, Chalkidou K, Chalmers I, Clarke M, Fenton M, Forbes C, Glanville J, Hicks NJ, Moody J, Twaddle S, Timimi H, Young P. How to formulate research recommendations. BMJ. 2006 Oct 14;333(7572):804-6. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. Epub 2006 Jul 12. — View Citation

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. — View Citation

Connelly LM. Pilot studies. Medsurg Nurs. 2008 Dec;17(6):411-2. Review. — View Citation

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. Review. — View Citation

Joy TR, Hegele RA. Narrative review: statin-related myopathy. Ann Intern Med. 2009 Jun 16;150(12):858-68. Review. — View Citation

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. — View Citation

Luzzi R, Belcaro G, Hu S, Dugall M, Hosoi M, Ippolito E, Corsi M, Gizzi G. Beanblock® (standardized dry extract of Phaseolus vulgaris) in mildly overweight subjects: a pilot study. Eur Rev Med Pharmacol Sci. 2014 Oct;18(20):3120-5. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum lipidemic profile evaluated at 6 months	laboratory test	6 months
Secondary	Serum lipidemic profile evaluated at 3 months	laboratory test	3 months
Secondary	AE/SAE (with particular regards for gastrointestinal symptoms)	blood clinical laboratory parameters; physical examination including weight, systolic blood pressure and diastolic blood pressure	6 months