Efficacy and Tolerability of the Nutraceutical Formulation Coleosoma in Dyslipidemic Subjects

NCT03027336 | Completed Phase 2 DMC

• 1 other identifier: COLEOSOMA 29-06
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

The overall objective of the study is to assess the efficacy of Coleosoma formulation (fermented red rice, berberine and chitosan) in reducing non-HDL cholesterol in dyslipidemic patients.

Conditions

Dyslipidemias

Keywords

dyslipidemia; dietary supplement

Outcome Measures

Primary Outcomes (1)

• Change from baseline values of non-HDL cholesterol (mg/dl) after 12 weeks of coleosoma treatment vs placebo

  Difference in the non-HDL cholesterol value compared to baseline in the 2 arms.

  12 weeks

Secondary Outcomes (11)

• change from baseline values of non-HDL cholesterol (mg/dl) at 4 weeks of coleosoma treatment vs placebo

  4 weeks

• change from baseline values of Free Plasma Glucose (mg/dl) at 12 weeks of coleosoma treatment vs placebo

  12 weeks

• change from baseline values of Body Mass Index (Kg/m2) at 12 weeks of coleosoma treatment vs placebo

  12 weeks

• change from baseline values of waist circumference (cm) at 12 weeks of coleosoma treatment vs placebo

  12 weeks

• Change from baseline values of HbA1C (%) at 12 weeks of coleosoma treatment vs placebo

  12 weeks

Study Arms (2)

coleosoma

EXPERIMENTAL

coleosoma 500mg tablet daily

Dietary Supplement: Coleosoma

placebo

PLACEBO COMPARATOR

placebo tablets

Dietary Supplement: Placebo

Interventions

Coleosoma DIETARY_SUPPLEMENT

patients will take one tablet of 500mg daily for 12 weeks. No dose titration is foreseen.

Also known as: TegraDOC

coleosoma

Placebo DIETARY_SUPPLEMENT

patients will take one tablet daily for 12 weeks.

placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• non-HDL cholesterol ≥ 160 mg/dl;
• providing their written Informed Consent;
• capable of understanding the nature, purpose and study procedures

You may not qualify if:

• diabetes (ADA criteria)
• reduced renal (GFR\<60 mL/min/1.73m2) or hepatic (transaminase levels \>2.5 folds the upper reference limit) function;
• present or past history of alcohol or drug abuse
• cerebro-vascular and neoplastic diseases in the 5 years prior to study visit
• use of drugs or food supplements interfering with cholesterol levels
• pregnancy or breastfeeding;
• monogenic dyslipidemia;
• participation in other clinical trials in the previous 30 days;
• uncompensated hypothyroidism

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria di Parma: lead
• DOC generici srl: collaborator

Study Sites (1)

Endocrinology Unit

Parma, Italy, 43126, Italy

Location

Related Publications (13)

• Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Blaha MJ, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Judd SE, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Mackey RH, Magid DJ, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Mussolino ME, Neumar RW, Nichol G, Pandey DK, Paynter NP, Reeves MJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2014 update: a report from the American Heart Association. Circulation. 2014 Jan 21;129(3):e28-e292. doi: 10.1161/01.cir.0000441139.02102.80. Epub 2013 Dec 18. No abstract available.

  PMID: 24352519 BACKGROUND

• Stone NJ, Robinson JG, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH, Goldberg AC, Gordon D, Levy D, Lloyd-Jones DM, McBride P, Schwartz JS, Shero ST, Smith SC Jr, Watson K, Wilson PW; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B):2889-934. doi: 10.1016/j.jacc.2013.11.002. Epub 2013 Nov 12. No abstract available.

  PMID: 24239923 BACKGROUND

• Boekholdt SM, Arsenault BJ, Mora S, Pedersen TR, LaRosa JC, Nestel PJ, Simes RJ, Durrington P, Hitman GA, Welch KM, DeMicco DA, Zwinderman AH, Clearfield MB, Downs JR, Tonkin AM, Colhoun HM, Gotto AM Jr, Ridker PM, Kastelein JJ. Association of LDL cholesterol, non-HDL cholesterol, and apolipoprotein B levels with risk of cardiovascular events among patients treated with statins: a meta-analysis. JAMA. 2012 Mar 28;307(12):1302-9. doi: 10.1001/jama.2012.366.

  PMID: 22453571 BACKGROUND

• El Harchaoui K, van der Steeg WA, Stroes ES, Kuivenhoven JA, Otvos JD, Wareham NJ, Hutten BA, Kastelein JJ, Khaw KT, Boekholdt SM. Value of low-density lipoprotein particle number and size as predictors of coronary artery disease in apparently healthy men and women: the EPIC-Norfolk Prospective Population Study. J Am Coll Cardiol. 2007 Feb 6;49(5):547-53. doi: 10.1016/j.jacc.2006.09.043. Epub 2007 Jan 22.

  PMID: 17276177 BACKGROUND

• Roura S, Galvez-Monton C, Bayes-Genis A. The challenges for cardiac vascular precursor cell therapy: lessons from a very elusive precursor. J Vasc Res. 2013;50(4):304-23. doi: 10.1159/000353294. Epub 2013 Jul 9.

  PMID: 23860201 BACKGROUND

• Vasa M, Fichtlscherer S, Aicher A, Adler K, Urbich C, Martin H, Zeiher AM, Dimmeler S. Number and migratory activity of circulating endothelial progenitor cells inversely correlate with risk factors for coronary artery disease. Circ Res. 2001 Jul 6;89(1):E1-7. doi: 10.1161/hh1301.093953.

  PMID: 11440984 BACKGROUND

• Hill JM, Zalos G, Halcox JP, Schenke WH, Waclawiw MA, Quyyumi AA, Finkel T. Circulating endothelial progenitor cells, vascular function, and cardiovascular risk. N Engl J Med. 2003 Feb 13;348(7):593-600. doi: 10.1056/NEJMoa022287.

  PMID: 12584367 BACKGROUND

• Dei Cas A, Spigoni V, Franzini L, Preti M, Ardigo D, Derlindati E, Metra M, Monti LD, Dell'Era P, Gnudi L, Zavaroni I. Lower endothelial progenitor cell number, family history of cardiovascular disease and reduced HDL-cholesterol levels are associated with shorter leukocyte telomere length in healthy young adults. Nutr Metab Cardiovasc Dis. 2013 Mar;23(3):272-8. doi: 10.1016/j.numecd.2011.04.005. Epub 2011 Aug 6.

  PMID: 21824757 BACKGROUND

• Dei Cas A, Spigoni V, Ardigo D, Pedrazzi G, Franzini L, Derlindati E, Urbani S, Monti L, Gnudi L, Zavaroni I. Reduced circulating endothelial progenitor cell number in healthy young adult hyperinsulinemic men. Nutr Metab Cardiovasc Dis. 2011 Jul;21(7):512-7. doi: 10.1016/j.numecd.2009.11.011. Epub 2010 Mar 15.

  PMID: 20227256 BACKGROUND

• Spigoni V, Lombardi C, Cito M, Picconi A, Ridolfi V, Andreoli R, Anelli N, Gnudi L, Goldoni M, Zavaroni I, Raddino R, Dei Cas A. N-3 PUFA increase bioavailability and function of endothelial progenitor cells. Food Funct. 2014 Aug;5(8):1881-90. doi: 10.1039/c3fo60641d.

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• Sola R, Valls RM, Puzo J, Calabuig JR, Brea A, Pedret A, Morina D, Villar J, Millan J, Anguera A. Effects of poly-bioactive compounds on lipid profile and body weight in a moderately hypercholesterolemic population with low cardiovascular disease risk: a multicenter randomized trial. PLoS One. 2014 Aug 1;9(8):e101978. doi: 10.1371/journal.pone.0101978. eCollection 2014.

  PMID: 25084280 BACKGROUND

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Alessandra Dei Cas, MD

  University of Parma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant, MD, PhD

Model Details: The study included two arms: a treatment arm with dietary supplement (Coleosoma) and a placebo arm. Coleosoma is the name of a new patented dietary supplement composed by Berberin 200 mg, Fermented Red Rice from Monascus purpureus 100 mg (correspondiing at 3 mg of monacolin K), Chitosan 100 mg e Q10 Coenzyme10 mg

Study Record Dates

• First Submitted: January 12, 2017
• First Posted: January 23, 2017
• Study Start: January 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: October 1, 2016
• Last Updated: January 23, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)