xml: <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/NCT05984745</url>
    </required_header>
    <id_info>
      <org_study_id>CoQ10 in MAFLD Patients</org_study_id>
      <nct_id>NCT05984745</nct_id>
    </id_info>
    <brief_title>Effect of CoQ10 on the Outcome of MAFLD Patients</brief_title>
    <official_title>Effect of Coenzyme Q10 on the Outcome of Metabolic Dysfunction-Associated Fatty Liver Disease Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ain Shams University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ain Shams University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        So far there has been no universal treatment for MAFLD since it has a complex etiology that&#xD;
        involves ethnic, genetic, metabolic and environmental factors. However, therapeutic life&#xD;
        changes including: diet, weight loss, and physical activity remain the cornerstone of&#xD;
        treatment and is recommended by both American and European associations.&#xD;
  &#xD;
        Inflammatory biomarkers, such as tumor necrosis factor-alpha, and adipokines play key roles&#xD;
        in the pathogenesis of MAFLD, hence, the anti-inflammatory and antioxidant effects of&#xD;
        coenzyme Q10 especially at high doses that have not been tested are hypothesized to have a&#xD;
        beneficial role in improving the systemic inflammation and biochemical variables.&#xD;
  &#xD;
        This study is conducted to test this hypothesis&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The liver disease with the most continuously rising prevalence rates is metabolic-dysfunction&#xD;
        associated fatty liver disease (MAFLD), making us arrive at a conclusion that it might be the&#xD;
        liver disease epidemic of the 21st century. It is increasingly diagnosed in many developed&#xD;
        and developing countries and is considered the most common cause of chronic liver disease&#xD;
        among patients with type 2 diabetes mellitus (T2DM). By 2030, it will be the leading cause&#xD;
        for hepatocellular carcinoma (HCC) related liver transplantation (LTx) in western countries.&#xD;
  &#xD;
        A number of studies have suggested that metabolic associated co-morbidities, such as obesity,&#xD;
        type 2 DM, CVD, dyslipidemia, hypertension, metabolic syndrome, hypothyroidism, OSAS, PCOS&#xD;
        are major risk factors for MAFLD.&#xD;
  &#xD;
        It encompasses a wide spectrum of histological pattern, ranging from simple steatosis to&#xD;
        steatohepatitis, fibrosis and cirrhosis.&#xD;
  &#xD;
        The global prevalence of MAFLD is currently estimated to be 25%, but the highest rates are&#xD;
        reported from the Middle East 31.8% and South America 30.5%, followed by Asia 27.4%, the USA&#xD;
        24% and Europe 23.7%, whereas MAFLD is less common in Africa 13.5%.&#xD;
  &#xD;
        Coenzyme Q10 (CoQ10) or ubiquinone is a lipid-soluble and vitamin-like compound, which acts&#xD;
        as a pivotal cofactor in the mitochondrial respiratory chain in addition to its role as a&#xD;
        natural scavenger of free radicals. It is synthesized by cells of the body and also found in&#xD;
        abundance in the human diet. Recent evidence suggests that CoQ10 supplementation might be&#xD;
        useful in improving and preventing pathological conditions such as metabolic syndrome,&#xD;
        hypertension, diabetes, liver diseases, and insulin resistance Because of its antioxidant&#xD;
        activity, it seems that CoQ10 can prevent activation of the inflammatory signaling pathway.&#xD;
        Many studies have shown that administration of CoQ10 reduced hepatic oxidative stress and&#xD;
        inflammation. Also, other studies observed that CoQ10 supplementation reduced TNF-α&#xD;
        production and serum levels of liver aminotransferase and decreased NF-kB expression. In&#xD;
        addition, a previously published study showed that a dose of 100 mg/day of CoQ10 for 4 weeks&#xD;
        can improve serum AST levels, total antioxidant capacity and waist circumference, but it had&#xD;
        a non-significant effect on insulin resistance and MDA levels. The same result was found in&#xD;
        the study by Esfahani et al. reporting improvement in AST and ALT concentrations and lower&#xD;
        grades of portal inflammation and hepatocellular liver necrosis in thioacetamide-induced&#xD;
        liver damage in rats. Yet, some contradicting results were reported by Hodgson et al. were&#xD;
        they found a non-significant reduction in body weight after CoQ10 supplementation in patients&#xD;
        with T2DM. These contradictions were addressed by Faresi et al. where they tested the effect&#xD;
        of the same oral dose of CoQ10 used by Farhangi et al. for 12 weeks, where it had beneficial&#xD;
        effects on serum levels of TNF-a, hs-CRP, hepatic enzymes, adiponectin, and NAFLD grades as&#xD;
        well as near-significant changes in serum leptin among patients with NAFLD. However, serum&#xD;
        IL-6 levels and AAR remained unchanged after CoQ10 supplementation.&#xD;
  &#xD;
        Till this day, only a few small studies tried to investigate the effect of CoQ10&#xD;
        administration on the degree of steatosis in MAFLD patients and their results failed to show&#xD;
        a clear effect, due to the conflicting and limited data. Hence, this encouraged us to study&#xD;
        the efficacy and tolerability of a higher dose of CoQ10 especially that it can be safely&#xD;
        administered up to a dose of 1200 mg/day. In addition, CoQ10 showed promising effects in&#xD;
        previous studies, so the general recommendation was to study its effect in a larger study&#xD;
        population, for longer periods.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">September 2024</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in liver steatosis degree</measure>
      <time_frame>Baseline and at 12 weeks</time_frame>
      <description>Improvement in steatosis degree will be assessed using Fibro-CAP scoring measured in decibels per meter (dB/m) and ranges from 100-400, where 238 to 260 dB/m represents 11-33% fatty change in the liver, 260 to 290 dB/m represents 34-66% fatty change in the liver and &gt; 290 dB/m represents almost 67% or more fatty change in the liver.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in serum levels of liver transaminases (AST and ALT) 3 months post treatment with Coenzyme Q10</measure>
      <time_frame>Baseline and at 12 weeks</time_frame>
      <description>Levels of alanine transaminase (ALT) and aspartate aminotransferase (AST) will be measured in serum where normal serum ALT is 7-56 U/L and normal serum AST is 0 to 35 U/L.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in serum levels of tumor necrosis factor-alpha (TNF-α) 3 months post treatment with Coenzyme Q10</measure>
      <time_frame>Baseline and at 12 weeks</time_frame>
      <description>TNF-α levels will be assessed in serum</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in the quality of life of MAFLD patients</measure>
      <time_frame>Baseline and at 12 weeks</time_frame>
      <description>Quality of life will be assessed using the Chronic Liver Disease (CLD) questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Study the drug's effect on kidney functions by measuring serum creatinine levels</measure>
      <time_frame>Baseline and at 12 weeks</time_frame>
      <description>Serum creatinine levels will be measured where the normal range is 0.74 to 1.35 mg/dL (61.9 to 114.9 µmol/L) for men and 0.59 to 1.04 mg/dL (53 to 97.2 µmol/L) for women</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">166</enrollment>
    <condition>Fatty Liver</condition>
    <condition>NAFLD</condition>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Patients will receive the standard conventional care which is mainly therapeutic life changes</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Test Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients will receive Coenzyme Q10 Forte® (MEPACO Pharmaceutical Company, Cairo, Egypt) capsules in a dose of 100 mg twice per day 1 capsule every 12 hours for twelve weeks, in addition to the standard conventional care.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Coenzyme Q10 Forte® capsules</intervention_name>
      <description>Coenzyme Q10 in the form of soft gelatin capsules, each capsule containing 100 mg</description>
      <arm_group_label>Test Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          All study subjects and prior to consenting to the ICF, laboratory and imaging work-up will&#xD;
          be evaluated for the presence of three out of five criteria for metabolic dysregulation in&#xD;
          the context of metabolic -dysfunction associated fatty liver disease (MAFLD):&#xD;
  &#xD;
            1. Waist circumference (WC) ≥ 102/88 cm for men and women respectively.&#xD;
  &#xD;
            2. HDL cholesterol &lt;40 mg/dl in men and &lt;50 mg/dl in women or on specific drug therapy.&#xD;
  &#xD;
            3. Plasma Triglycerides ≥ 150 mg/dl or on specific drug therapy.&#xD;
  &#xD;
            4. Blood pressure ≥130 and/or ≥ 85 or on specific anti-hypertensive therapy.&#xD;
  &#xD;
            5. Fasting blood glucose ≥ 100 mg/dl or on specific anti hyperglycemic therapy&#xD;
  &#xD;
                 -  Patients who agree to sign an informed consent&#xD;
  &#xD;
                 -  Adult patients &gt;18 years old.&#xD;
  &#xD;
                 -  Males and females&#xD;
  &#xD;
                 -  Willing to comply with procedures and follow up&#xD;
  &#xD;
                 -  Elevated serum transaminases (1-4 times the ULN)&#xD;
  &#xD;
                 -  Imaging evidence of fatty liver:&#xD;
  &#xD;
          pelviabdominal ultrasound and Fibro- CAP study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnancy or lactating&#xD;
  &#xD;
            -  Physical or mental abnormalities&#xD;
  &#xD;
            -  HCV infection&#xD;
  &#xD;
            -  HBV infection&#xD;
  &#xD;
            -  Anaemia&#xD;
  &#xD;
            -  Thrombocytopenia&#xD;
  &#xD;
            -  Haematological malignancies&#xD;
  &#xD;
            -  Ongoing alcoholism (Male: &gt;30g/day, Female: &gt;20g/day)&#xD;
  &#xD;
            -  Patients with renal failure&#xD;
  &#xD;
            -  Autoimmune hepatitis&#xD;
  &#xD;
            -  Celiac disease&#xD;
  &#xD;
            -  Wilson's disease&#xD;
  &#xD;
            -  Hemochromatosis&#xD;
  &#xD;
            -  Drugs: Tamoxifen, Valproic acid, Amiodarone, Methotrexate, Steroids, Anticoagulants,&#xD;
               All anti-oxidative stress agents, Cos, IUD&#xD;
  &#xD;
            -  Chronic use of systematically immunosuppressive agent or drugs that can affect liver&#xD;
               profile.&#xD;
  &#xD;
            -  Hypo/Hyper-thyroidism&#xD;
  &#xD;
            -  Bypass surgeries&#xD;
  &#xD;
            -  TPN (Total Parenteral Nutrition)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Mariam Seif</last_name>
      <phone>+201112720114</phone>
      <email>mariam.talaat@pharma.asu.edu.eg</email>
    </overall_contact>
    <reference>
      <citation>Younossi Z, Anstee QM, Marietti M, Hardy T, Henry L, Eslam M, George J, Bugianesi E. Global burden of NAFLD and NASH: trends, predictions, risk factors and prevention. Nat Rev Gastroenterol Hepatol. 2018 Jan;15(1):11-20. doi: 10.1038/nrgastro.2017.109. Epub 2017 Sep 20.</citation>
      <PMID>28930295</PMID>
    </reference>
    <reference>
      <citation>Allen AM, Therneau TM, Larson JJ, Coward A, Somers VK, Kamath PS. Nonalcoholic fatty liver disease incidence and impact on metabolic burden and death: A 20 year-community study. Hepatology. 2018 May;67(5):1726-1736. doi: 10.1002/hep.29546. Epub 2018 Mar 23.</citation>
      <PMID>28941364</PMID>
    </reference>
    <reference>
      <citation>McPherson S, Hardy T, Henderson E, Burt AD, Day CP, Anstee QM. Evidence of NAFLD progression from steatosis to fibrosing-steatohepatitis using paired biopsies: implications for prognosis and clinical management. J Hepatol. 2015 May;62(5):1148-55. doi: 10.1016/j.jhep.2014.11.034. Epub 2014 Dec 1.</citation>
      <PMID>25477264</PMID>
    </reference>
    <reference>
      <citation>Younossi ZM, Koenig AB, Abdelatif D, Fazel Y, Henry L, Wymer M. Global epidemiology of nonalcoholic fatty liver disease-Meta-analytic assessment of prevalence, incidence, and outcomes. Hepatology. 2016 Jul;64(1):73-84. doi: 10.1002/hep.28431. Epub 2016 Feb 22.</citation>
      <PMID>26707365</PMID>
    </reference>
    <reference>
      <citation>Alam MA, Rahman MM. Mitochondrial dysfunction in obesity: potential benefit and mechanism of Co-enzyme Q10 supplementation in metabolic syndrome. J Diabetes Metab Disord. 2014 May 23;13:60. doi: 10.1186/2251-6581-13-60. eCollection 2014.</citation>
      <PMID>24932457</PMID>
    </reference>
    <reference>
      <citation>Fuller B, Smith D, Howerton A, Kern D. Anti-inflammatory effects of CoQ10 and colorless carotenoids. J Cosmet Dermatol. 2006 Mar;5(1):30-8. doi: 10.1111/j.1473-2165.2006.00220.x.</citation>
      <PMID>17173569</PMID>
    </reference>
    <reference>
      <citation>Sohet FM, Neyrinck AM, Pachikian BD, de Backer FC, Bindels LB, Niklowitz P, Menke T, Cani PD, Delzenne NM. Coenzyme Q10 supplementation lowers hepatic oxidative stress and inflammation associated with diet-induced obesity in mice. Biochem Pharmacol. 2009 Dec 1;78(11):1391-400. doi: 10.1016/j.bcp.2009.07.008. Epub 2009 Jul 23.</citation>
      <PMID>19632207</PMID>
    </reference>
    <reference>
      <citation>Bravo E, Palleschi S, Rossi B, Napolitano M, Tiano L, D'Amore E, Botham KM. Coenzyme Q metabolism is disturbed in high fat diet-induced non-alcoholic fatty liver disease in rats. Int J Mol Sci. 2012;13(2):1644-1657. doi: 10.3390/ijms13021644. Epub 2012 Feb 2.</citation>
      <PMID>22408414</PMID>
    </reference>
    <reference>
      <citation>Ashkani Esfahani S, Esmaeilzadeh E, Bagheri F, Emami Y, Farjam M. The effect of co-enzyme q10 on acute liver damage in rats, a biochemical and pathological study. Hepat Mon. 2013 Aug 27;13(8):e13685. doi: 10.5812/hepatmon.13685. eCollection 2013. No abstract available.</citation>
      <PMID>24130601</PMID>
    </reference>
    <reference>
      <citation>Farsi F, Mohammadshahi M, Alavinejad P, Rezazadeh A, Zarei M, Engali KA. Functions of Coenzyme Q10 Supplementation on Liver Enzymes, Markers of Systemic Inflammation, and Adipokines in Patients Affected by Nonalcoholic Fatty Liver Disease: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial. J Am Coll Nutr. 2016 May-Jun;35(4):346-53. doi: 10.1080/07315724.2015.1021057. Epub 2015 Jul 9.</citation>
      <PMID>26156412</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ain Shams University</investigator_affiliation>
      <investigator_full_name>Mariam Talaat</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Coenzyme Q10</keyword>
    <keyword>Liver steatosis</keyword>
    <keyword>TNF alpha</keyword>
    <keyword>Fatty Liver</keyword>
    <keyword>Inflammation</keyword>
    <keyword>MAFLD</keyword>
    <keyword>CoQ10</keyword>
    <keyword>Ubiquinone</keyword>
    <keyword>Liver Disease</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fatty Liver</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Ubiquinone</mesh_term>
      <mesh_term>Coenzyme Q10</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05984745
  org study id: CoQ10 in MAFLD Patients
  nct id: NCT05984745
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  So far there has been no universal treatment for MAFLD since it has a complex etiology that
        involves ethnic, genetic, metabolic and environmental factors. However, therapeutic life
        changes including: diet, weight loss, and physical activity remain the cornerstone of
        treatment and is recommended by both American and European associations.
  
        Inflammatory biomarkers, such as tumor necrosis factor-alpha, and adipokines play key roles
        in the pathogenesis of MAFLD, hence, the anti-inflammatory and antioxidant effects of
        coenzyme Q10 especially at high doses that have not been tested are hypothesized to have a
        beneficial role in improving the systemic inflammation and biochemical variables.
  
        This study is conducted to test this hypothesis
  The liver disease with the most continuously rising prevalence rates is metabolic-dysfunction
        associated fatty liver disease (MAFLD), making us arrive at a conclusion that it might be the
        liver disease epidemic of the 21st century. It is increasingly diagnosed in many developed
        and developing countries and is considered the most common cause of chronic liver disease
        among patients with type 2 diabetes mellitus (T2DM). By 2030, it will be the leading cause
        for hepatocellular carcinoma (HCC) related liver transplantation (LTx) in western countries.
  
        A number of studies have suggested that metabolic associated co-morbidities, such as obesity,
        type 2 DM, CVD, dyslipidemia, hypertension, metabolic syndrome, hypothyroidism, OSAS, PCOS
        are major risk factors for MAFLD.
  
        It encompasses a wide spectrum of histological pattern, ranging from simple steatosis to
        steatohepatitis, fibrosis and cirrhosis.
  
        The global prevalence of MAFLD is currently estimated to be 25%, but the highest rates are
        reported from the Middle East 31.8% and South America 30.5%, followed by Asia 27.4%, the USA
        24% and Europe 23.7%, whereas MAFLD is less common in Africa 13.5%.
  
        Coenzyme Q10 (CoQ10) or ubiquinone is a lipid-soluble and vitamin-like compound, which acts
        as a pivotal cofactor in the mitochondrial respiratory chain in addition to its role as a
        natural scavenger of free radicals. It is synthesized by cells of the body and also found in
        abundance in the human diet. Recent evidence suggests that CoQ10 supplementation might be
        useful in improving and preventing pathological conditions such as metabolic syndrome,
        hypertension, diabetes, liver diseases, and insulin resistance Because of its antioxidant
        activity, it seems that CoQ10 can prevent activation of the inflammatory signaling pathway.
        Many studies have shown that administration of CoQ10 reduced hepatic oxidative stress and
        inflammation. Also, other studies observed that CoQ10 supplementation reduced TNF-α
        production and serum levels of liver aminotransferase and decreased NF-kB expression. In
        addition, a previously published study showed that a dose of 100 mg/day of CoQ10 for 4 weeks
        can improve serum AST levels, total antioxidant capacity and waist circumference, but it had
        a non-significant effect on insulin resistance and MDA levels. The same result was found in
        the study by Esfahani et al. reporting improvement in AST and ALT concentrations and lower
        grades of portal inflammation and hepatocellular liver necrosis in thioacetamide-induced
        liver damage in rats. Yet, some contradicting results were reported by Hodgson et al. were
        they found a non-significant reduction in body weight after CoQ10 supplementation in patients
        with T2DM. These contradictions were addressed by Faresi et al. where they tested the effect
        of the same oral dose of CoQ10 used by Farhangi et al. for 12 weeks, where it had beneficial
        effects on serum levels of TNF-a, hs-CRP, hepatic enzymes, adiponectin, and NAFLD grades as
        well as near-significant changes in serum leptin among patients with NAFLD. However, serum
        IL-6 levels and AAR remained unchanged after CoQ10 supplementation.
  
        Till this day, only a few small studies tried to investigate the effect of CoQ10
        administration on the degree of steatosis in MAFLD patients and their results failed to show
        a clear effect, due to the conflicting and limited data. Hence, this encouraged us to study
        the efficacy and tolerability of a higher dose of CoQ10 especially that it can be safely
        administered up to a dose of 1200 mg/day. In addition, CoQ10 showed promising effects in
        previous studies, so the general recommendation was to study its effect in a larger study
        population, for longer periods.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change in liver steatosis degree
  time frame: Baseline and at 12 weeks
  description: Improvement in steatosis degree will be assessed using Fibro-CAP scoring measured in decibels per meter (dB/m) and ranges from 100-400, where 238 to 260 dB/m represents 11-33% fatty change in the liver, 260 to 290 dB/m represents 34-66% fatty change in the liver and > 290 dB/m represents almost 67% or more fatty change in the liver.
  measure: Change in serum levels of liver transaminases (AST and ALT) 3 months post treatment with Coenzyme Q10
  time frame: Baseline and at 12 weeks
  description: Levels of alanine transaminase (ALT) and aspartate aminotransferase (AST) will be measured in serum where normal serum ALT is 7-56 U/L and normal serum AST is 0 to 35 U/L.
  measure: Change in serum levels of tumor necrosis factor-alpha (TNF-α) 3 months post treatment with Coenzyme Q10
  time frame: Baseline and at 12 weeks
  description: TNF-α levels will be assessed in serum
  measure: Change in the quality of life of MAFLD patients
  time frame: Baseline and at 12 weeks
  description: Quality of life will be assessed using the Chronic Liver Disease (CLD) questionnaire
  measure: Study the drug's effect on kidney functions by measuring serum creatinine levels
  time frame: Baseline and at 12 weeks
  description: Serum creatinine levels will be measured where the normal range is 0.74 to 1.35 mg/dL (61.9 to 114.9 µmol/L) for men and 0.59 to 1.04 mg/dL (53 to 97.2 µmol/L) for women
  arm group label: Control group
  arm group type: No Intervention
  description: Patients will receive the standard conventional care which is mainly therapeutic life changes
  arm group label: Test Group
  arm group type: Experimental
  description: Patients will receive Coenzyme Q10 Forte® (MEPACO Pharmaceutical Company, Cairo, Egypt) capsules in a dose of 100 mg twice per day 1 capsule every 12 hours for twelve weeks, in addition to the standard conventional care.
  intervention type: Drug
  intervention name: Coenzyme Q10 Forte® capsules
  description: Coenzyme Q10 in the form of soft gelatin capsules, each capsule containing 100 mg
  arm group label: Test Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Mariam Seif
  phone: +201112720114
  email: mariam.talaat@pharma.asu.edu.eg
  citation: Younossi Z, Anstee QM, Marietti M, Hardy T, Henry L, Eslam M, George J, Bugianesi E. Global burden of NAFLD and NASH: trends, predictions, risk factors and prevention. Nat Rev Gastroenterol Hepatol. 2018 Jan;15(1):11-20. doi: 10.1038/nrgastro.2017.109. Epub 2017 Sep 20.
  PMID: 28930295
  citation: Allen AM, Therneau TM, Larson JJ, Coward A, Somers VK, Kamath PS. Nonalcoholic fatty liver disease incidence and impact on metabolic burden and death: A 20 year-community study. Hepatology. 2018 May;67(5):1726-1736. doi: 10.1002/hep.29546. Epub 2018 Mar 23.
  PMID: 28941364
  citation: McPherson S, Hardy T, Henderson E, Burt AD, Day CP, Anstee QM. Evidence of NAFLD progression from steatosis to fibrosing-steatohepatitis using paired biopsies: implications for prognosis and clinical management. J Hepatol. 2015 May;62(5):1148-55. doi: 10.1016/j.jhep.2014.11.034. Epub 2014 Dec 1.
  PMID: 25477264
  citation: Younossi ZM, Koenig AB, Abdelatif D, Fazel Y, Henry L, Wymer M. Global epidemiology of nonalcoholic fatty liver disease-Meta-analytic assessment of prevalence, incidence, and outcomes. Hepatology. 2016 Jul;64(1):73-84. doi: 10.1002/hep.28431. Epub 2016 Feb 22.
  PMID: 26707365
  citation: Alam MA, Rahman MM. Mitochondrial dysfunction in obesity: potential benefit and mechanism of Co-enzyme Q10 supplementation in metabolic syndrome. J Diabetes Metab Disord. 2014 May 23;13:60. doi: 10.1186/2251-6581-13-60. eCollection 2014.
  PMID: 24932457
  citation: Fuller B, Smith D, Howerton A, Kern D. Anti-inflammatory effects of CoQ10 and colorless carotenoids. J Cosmet Dermatol. 2006 Mar;5(1):30-8. doi: 10.1111/j.1473-2165.2006.00220.x.
  PMID: 17173569
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  PMID: 26156412
  responsible party type: Principal Investigator
  investigator affiliation: Ain Shams University
  investigator full name: Mariam Talaat
  investigator title: Principal Investigator
  mesh term: Fatty Liver
  mesh term: Ubiquinone
  mesh term: Coenzyme Q10
  sharing ipd: Undecided