<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03027336</url>
  </required_header>
  <id_info>
    <org_study_id>COLEOSOMA 29-06</org_study_id>
    <nct_id>NCT03027336</nct_id>
  </id_info>
  <brief_title>Efficacy and Tolerability of the Nutraceutical Formulation Coleosoma in Dyslipidemic Subjects</brief_title>
  <acronym>Coleosoma</acronym>
  <official_title>Randomized Controlled Clinical Trial for Assessing Tolerability and Effectiveness of Formula Coleosoma 29 in Patients With Dyslipidemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azienda Ospedaliero-Universitaria di Parma</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>DOC generici srl</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Azienda Ospedaliero-Universitaria di Parma</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall objective of the study is to assess the efficacy of Coleosoma formulation&#xD;
      (fermented red rice, berberine and chitosan) in reducing non-HDL cholesterol in dyslipidemic&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The incidence of cardiovascular diseases related to atherosclerosis is the leading cause of&#xD;
      death in industrialized countries and in many developing countries. It becomes, therefore,&#xD;
      essential to implement preventive strategies with lifestyle changes in order to prevent /&#xD;
      control the risk factors related to cardiovascular disease.&#xD;
&#xD;
      Dyslipidemia is characterized by qualitative and quantitative alterations of plasma lipids&#xD;
      and lipoproteins. In subjects where it is not yet indicated a statin therapy, the guidelines&#xD;
      recommend a lifestyle (diet and exercise) act to control cardiovascular risk factors.&#xD;
&#xD;
      The formulation Coleosoma is a supplement composed of fermented red rice, berberine and&#xD;
      chitosan. Aim of the study is to evaluate the effectiveness of coleosoma formulation in&#xD;
      reducing non-HDL cholesterol (Non-HDL-C), which provides a measure of the cholesterol content&#xD;
      in all atherogenic particles.&#xD;
&#xD;
      This is a single-center, randomized (3:1) and controlled double-blind phase II study that&#xD;
      involve dyslipidemic patients with non-HDL cholesterol levels ≥ 160 mg / dl.&#xD;
&#xD;
      The study included a maximum of 4 visits for all subjects enrolled. All eligible patients at&#xD;
      V0 (screening) undergo baseline assessments (V1) and have been allocated according to the&#xD;
      procedure of randomization to one of the study arms. Follow-up (FU) visits for all subjects&#xD;
      was at 4 (V2) and at 12 weeks (V3) after randomization.&#xD;
&#xD;
      Laboratory and diagnostic:&#xD;
&#xD;
      At each visits patients undergo: anthropometric and hemodynamic assessment: weight and height&#xD;
      for Body Mass Index (BMI) calculation, waist circumference, blood pressure, heart rate; blood&#xD;
      collection for metabolic/hormonal profile: fasting plasma glucose, HbA1c, insulin, glucagon,&#xD;
      active glucagon-like peptide-1 (GLP-1), total gastric inhibitory polypeptide (GIP), total&#xD;
      cholesterol, HDL-cholesterol, triglycerides, aspartate aminotransferase (AST), alanine&#xD;
      aminotransferase (ALT), creatinine, creatine phosphokinase (CPK), apolipoprotein (Apo) B, Apo&#xD;
      A1, and inflammatory cytokines (IL-1, IL-6, IL-10, high-sensitivity C Reactive Protein&#xD;
      (hsPCR), TNFalpha).&#xD;
&#xD;
      At V1 and V2 the Endothelial Progenitor Cells (EPC) number was evaluated with a&#xD;
      cytofluorimetric assay.&#xD;
&#xD;
      Safety analysis has been conducted after 12 weeks treatment by determining ALT, CPK and&#xD;
      estimated Glomerular filtration rate (eGFR) values.&#xD;
&#xD;
      This study has been sponsored by DOC generici s.r.l.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>The study included two arms: a treatment arm with dietary supplement (Coleosoma) and a placebo arm.&#xD;
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</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline values of non-HDL cholesterol (mg/dl) after 12 weeks of coleosoma treatment vs placebo</measure>
    <time_frame>12 weeks</time_frame>
    <description>Difference in the non-HDL cholesterol value compared to baseline in the 2 arms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change from baseline values of non-HDL cholesterol (mg/dl) at 4 weeks of coleosoma treatment vs placebo</measure>
    <time_frame>4 weeks</time_frame>
    <description>Difference in the non-HDL cholesterol value compared to baseline in the 2 arms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change from baseline values of Free Plasma Glucose (mg/dl) at 12 weeks of coleosoma treatment vs placebo</measure>
    <time_frame>12 weeks</time_frame>
    <description>Difference in the Free Plasma Glucose value compared to baseline in the 2 arms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change from baseline values of Body Mass Index (Kg/m2) at 12 weeks of coleosoma treatment vs placebo</measure>
    <time_frame>12 weeks</time_frame>
    <description>Difference in the BMI value compared to baseline in the 2 arms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change from baseline values of waist circumference (cm) at 12 weeks of coleosoma treatment vs placebo</measure>
    <time_frame>12 weeks</time_frame>
    <description>Difference in the waist circumference value compared to baseline in the 2 arms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline values of HbA1C (%) at 12 weeks of coleosoma treatment vs placebo</measure>
    <time_frame>12 weeks</time_frame>
    <description>Difference in the HbA1C value compared to baseline in the 2 arms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline values of LDL Cholesterol, triglycerides and HDL cholesterol at 12 weeks of coleosoma treatment vs placebo</measure>
    <time_frame>12 weeks</time_frame>
    <description>Difference in theLDL Cholesterol, triglycerides and HDL cholesterol value compared to baseline in the 2 arms.&#xD;
All these parameters have the same Units of Measure (mg/dl)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline values of ApoB/Apo A1 ratio at 12 weeks of coleosoma treatment vs placebo</measure>
    <time_frame>12 weeks</time_frame>
    <description>Difference in the ApoB/Apo A1ratio compared to baseline in the 2 arms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline values of inflammatory cytokines (IL-1, IL6, IL-10, hsPCR, TNFalpha ) at 12 weeks of coleosoma treatment vs placebo</measure>
    <time_frame>12 weeks</time_frame>
    <description>Difference in the inflammatory cytokines value compared to baseline in the 2 arms.&#xD;
All these parameters have the same Units of Measure (pg/ml)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline values of insulin (pmol/l) at 12 weeks of coleosoma treatment vs placebo</measure>
    <time_frame>12 weeks</time_frame>
    <description>Difference in the insulin value compared to baseline in the 2 arms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline values of hormone profile (glucagon, active GLP-1 and GIP) at 12 weeks of coleosoma treatment vs placebo</measure>
    <time_frame>12 weeks</time_frame>
    <description>Difference in the hormone profile compared to baseline in the 2 arms. All these parameters have the same Units of Measure (pg/ml)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline values of Endothelial Progenitor Cells (EPC) number at 12 weeks of coleosoma treatment vs placebo</measure>
    <time_frame>12 weeks</time_frame>
    <description>Difference in the EPC number compared to baseline in the 2 arms.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Dyslipidemias</condition>
  <arm_group>
    <arm_group_label>coleosoma</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>coleosoma 500mg tablet daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>placebo tablets</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Coleosoma</intervention_name>
    <description>patients will take one tablet of 500mg daily for 12 weeks. No dose titration is foreseen.</description>
    <arm_group_label>coleosoma</arm_group_label>
    <other_name>TegraDOC</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>patients will take one tablet daily for 12 weeks.</description>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  non-HDL cholesterol ≥ 160 mg/dl;&#xD;
&#xD;
          -  providing their written Informed Consent;&#xD;
&#xD;
          -  capable of understanding the nature, purpose and study procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  diabetes (ADA criteria)&#xD;
&#xD;
          -  reduced renal (GFR&lt;60 mL/min/1.73m2) or hepatic (transaminase levels &gt;2.5 folds the&#xD;
             upper reference limit) function;&#xD;
&#xD;
          -  present or past history of alcohol or drug abuse&#xD;
&#xD;
          -  cerebro-vascular and neoplastic diseases in the 5 years prior to study visit&#xD;
&#xD;
          -  use of drugs or food supplements interfering with cholesterol levels&#xD;
&#xD;
          -  pregnancy or breastfeeding;&#xD;
&#xD;
          -  monogenic dyslipidemia;&#xD;
&#xD;
          -  participation in other clinical trials in the previous 30 days;&#xD;
&#xD;
          -  uncompensated hypothyroidism&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alessandra Dei Cas, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Parma</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Endocrinology Unit</name>
      <address>
        <city>Parma</city>
        <zip>43126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>24352519</PMID>
  </reference>
  <reference>
    <citation>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. Erratum In: J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B):3024-3025. J Am Coll Cardiol. 2015 Dec 22;66(24):2812.</citation>
    <PMID>24239923</PMID>
  </reference>
  <reference>
    <citation>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. Erratum In: JAMA. 2012 Apr 25;307(16):1694. JAMA. 2012 May 9;307(18):1915.</citation>
    <PMID>22453571</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>17276177</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>23860201</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>11440984</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>12584367</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>21824757</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>20227256</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>24942553</PMID>
  </reference>
  <reference>
    <citation>Akhter J. The American Diabetes Association's Clinical Practice Recommendations and the developing world. Diabetes Care. 1997 Jun;20(6):1044-5. doi: 10.2337/diacare.20.6.1044b. No abstract available.</citation>
    <PMID>9167126</PMID>
  </reference>
  <reference>
    <citation>Pugliese G, Solini A, Bonora E, Orsi E, Zerbini G, Giorgino F, Cavalot F, Pontiroli AE, Baroni MG, Morano S, Nicolucci A, Penno G. The Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation provides a better definition of cardiovascular burden associated with CKD than the Modification of Diet in Renal Disease (MDRD) Study formula in subjects with type 2 diabetes. Atherosclerosis. 2011 Sep;218(1):194-9. doi: 10.1016/j.atherosclerosis.2011.04.035. Epub 2011 May 6.</citation>
    <PMID>21612781</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>25084280</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>January 19, 2017</last_update_submitted>
  <last_update_submitted_qc>January 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Azienda Ospedaliero-Universitaria di Parma</investigator_affiliation>
    <investigator_full_name>Alessandra Dei Cas</investigator_full_name>
    <investigator_title>Research Assistant, MD, PhD</investigator_title>
  </responsible_party>
  <keyword>dyslipidemia</keyword>
  <keyword>dietary supplement</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dyslipidemias</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03027336
org study id: COLEOSOMA 29-06
nct id: NCT03027336
lead sponsor: 
collaborator: 
has dmc: Yes
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.
The incidence of cardiovascular diseases related to atherosclerosis is the leading cause of
      death in industrialized countries and in many developing countries. It becomes, therefore,
      essential to implement preventive strategies with lifestyle changes in order to prevent /
      control the risk factors related to cardiovascular disease.

      Dyslipidemia is characterized by qualitative and quantitative alterations of plasma lipids
      and lipoproteins. In subjects where it is not yet indicated a statin therapy, the guidelines
      recommend a lifestyle (diet and exercise) act to control cardiovascular risk factors.

      The formulation Coleosoma is a supplement composed of fermented red rice, berberine and
      chitosan. Aim of the study is to evaluate the effectiveness of coleosoma formulation in
      reducing non-HDL cholesterol (Non-HDL-C), which provides a measure of the cholesterol content
      in all atherogenic particles.

      This is a single-center, randomized (3:1) and controlled double-blind phase II study that
      involve dyslipidemic patients with non-HDL cholesterol levels ≥ 160 mg / dl.

      The study included a maximum of 4 visits for all subjects enrolled. All eligible patients at
      V0 (screening) undergo baseline assessments (V1) and have been allocated according to the
      procedure of randomization to one of the study arms. Follow-up (FU) visits for all subjects
      was at 4 (V2) and at 12 weeks (V3) after randomization.

      Laboratory and diagnostic:

      At each visits patients undergo: anthropometric and hemodynamic assessment: weight and height
      for Body Mass Index (BMI) calculation, waist circumference, blood pressure, heart rate; blood
      collection for metabolic/hormonal profile: fasting plasma glucose, HbA1c, insulin, glucagon,
      active glucagon-like peptide-1 (GLP-1), total gastric inhibitory polypeptide (GIP), total
      cholesterol, HDL-cholesterol, triglycerides, aspartate aminotransferase (AST), alanine
      aminotransferase (ALT), creatinine, creatine phosphokinase (CPK), apolipoprotein (Apo) B, Apo
      A1, and inflammatory cytokines (IL-1, IL-6, IL-10, high-sensitivity C Reactive Protein
      (hsPCR), TNFalpha).

      At V1 and V2 the Endothelial Progenitor Cells (EPC) number was evaluated with a
      cytofluorimetric assay.

      Safety analysis has been conducted after 12 weeks treatment by determining ALT, CPK and
      estimated Glomerular filtration rate (eGFR) values.

      This study has been sponsored by DOC generici s.r.l.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 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
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change from baseline values of non-HDL cholesterol (mg/dl) after 12 weeks of coleosoma treatment vs placebo
time frame: 12 weeks
description: Difference in the non-HDL cholesterol value compared to baseline in the 2 arms.
measure: change from baseline values of non-HDL cholesterol (mg/dl) at 4 weeks of coleosoma treatment vs placebo
time frame: 4 weeks
description: Difference in the non-HDL cholesterol value compared to baseline in the 2 arms.
measure: change from baseline values of Free Plasma Glucose (mg/dl) at 12 weeks of coleosoma treatment vs placebo
time frame: 12 weeks
description: Difference in the Free Plasma Glucose value compared to baseline in the 2 arms.
measure: change from baseline values of Body Mass Index (Kg/m2) at 12 weeks of coleosoma treatment vs placebo
time frame: 12 weeks
description: Difference in the BMI value compared to baseline in the 2 arms.
measure: change from baseline values of waist circumference (cm) at 12 weeks of coleosoma treatment vs placebo
time frame: 12 weeks
description: Difference in the waist circumference value compared to baseline in the 2 arms.
measure: Change from baseline values of HbA1C (%) at 12 weeks of coleosoma treatment vs placebo
time frame: 12 weeks
description: Difference in the HbA1C value compared to baseline in the 2 arms.
measure: Change from baseline values of LDL Cholesterol, triglycerides and HDL cholesterol at 12 weeks of coleosoma treatment vs placebo
time frame: 12 weeks
description: Difference in theLDL Cholesterol, triglycerides and HDL cholesterol value compared to baseline in the 2 arms.
All these parameters have the same Units of Measure (mg/dl)
measure: Change from baseline values of ApoB/Apo A1 ratio at 12 weeks of coleosoma treatment vs placebo
time frame: 12 weeks
description: Difference in the ApoB/Apo A1ratio compared to baseline in the 2 arms.
measure: Change from baseline values of inflammatory cytokines (IL-1, IL6, IL-10, hsPCR, TNFalpha ) at 12 weeks of coleosoma treatment vs placebo
time frame: 12 weeks
description: Difference in the inflammatory cytokines value compared to baseline in the 2 arms.
All these parameters have the same Units of Measure (pg/ml)
measure: Change from baseline values of insulin (pmol/l) at 12 weeks of coleosoma treatment vs placebo
time frame: 12 weeks
description: Difference in the insulin value compared to baseline in the 2 arms.
measure: Change from baseline values of hormone profile (glucagon, active GLP-1 and GIP) at 12 weeks of coleosoma treatment vs placebo
time frame: 12 weeks
description: Difference in the hormone profile compared to baseline in the 2 arms. All these parameters have the same Units of Measure (pg/ml)
measure: Change from baseline values of Endothelial Progenitor Cells (EPC) number at 12 weeks of coleosoma treatment vs placebo
time frame: 12 weeks
description: Difference in the EPC number compared to baseline in the 2 arms.
arm group label: coleosoma
arm group type: Experimental
description: coleosoma 500mg tablet daily
arm group label: placebo
arm group type: Placebo Comparator
description: placebo tablets
intervention type: Dietary Supplement
intervention name: Coleosoma
description: patients will take one tablet of 500mg daily for 12 weeks. No dose titration is foreseen.
arm group label: coleosoma
other name: TegraDOC
intervention type: Dietary Supplement
intervention name: Placebo
description: patients will take one tablet daily for 12 weeks.
arm group label: placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Alessandra Dei Cas, MD
role: Principal Investigator
affiliation: University of Parma
facility: 
country: Italy
citation: 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
citation: 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. Erratum In: J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B):3024-3025. J Am Coll Cardiol. 2015 Dec 22;66(24):2812.
PMID: 24239923
citation: 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. Erratum In: JAMA. 2012 Apr 25;307(16):1694. JAMA. 2012 May 9;307(18):1915.
PMID: 22453571
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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.
PMID: 24942553
citation: Akhter J. The American Diabetes Association's Clinical Practice Recommendations and the developing world. Diabetes Care. 1997 Jun;20(6):1044-5. doi: 10.2337/diacare.20.6.1044b. No abstract available.
PMID: 9167126
citation: Pugliese G, Solini A, Bonora E, Orsi E, Zerbini G, Giorgino F, Cavalot F, Pontiroli AE, Baroni MG, Morano S, Nicolucci A, Penno G. The Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation provides a better definition of cardiovascular burden associated with CKD than the Modification of Diet in Renal Disease (MDRD) Study formula in subjects with type 2 diabetes. Atherosclerosis. 2011 Sep;218(1):194-9. doi: 10.1016/j.atherosclerosis.2011.04.035. Epub 2011 May 6.
PMID: 21612781
citation: 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
responsible party type: Principal Investigator
investigator affiliation: Azienda Ospedaliero-Universitaria di Parma
investigator full name: Alessandra Dei Cas
investigator title: Research Assistant, MD, PhD
mesh term: Dyslipidemias
sharing ipd: No