Effect of CoQ10 on the Outcome of MAFLD Patients

NCT05984745 | Recruiting Phase 2 DMC

• 1 other identifier: CoQ10 in MAFLD Patients
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fatty Liver; NAFLD

Keywords

Coenzyme Q10; Liver steatosis; TNF alpha; Fatty Liver; Inflammation; MAFLD; CoQ10; Ubiquinone; Liver Disease

Outcome Measures

Primary Outcomes (1)

• Change in liver steatosis degree

  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.

  Baseline and at 12 weeks

Secondary Outcomes (5)

• Change in serum levels of tumor necrosis factor-alpha (TNF-α) 3 months post treatment with Coenzyme Q10

  Baseline and at 12 weeks

• Change in serum levels of cytokeratin-18 (CK-18) 3 months post treatment with Coenzyme Q10

  Baseline and at 12 weeks

• Change in serum levels of liver transaminases (AST and ALT) 3 months post treatment with Coenzyme Q10

  Baseline and at 12 weeks

• Study the drug's effect on kidney functions by measuring serum creatinine levels

  Baseline and at 12 weeks

• Change in the quality of life of MAFLD patients

  Baseline and at 12 weeks

Study Arms (2)

Control group

NO INTERVENTION

Patients will receive the standard conventional care which is mainly therapeutic life changes

Test Group

EXPERIMENTAL

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.

Drug: Coenzyme Q10 Forte® capsules

Interventions

Coenzyme Q10 Forte® capsules DRUG

Coenzyme Q10 in the form of soft gelatin capsules, each capsule containing 100 mg

Test Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All study subjects and prior to consenting to the ICF, laboratory and imaging work-up will be evaluated for the presence of three out of five criteria for metabolic dysregulation in the context of metabolic -dysfunction associated fatty liver disease (MAFLD):
• Waist circumference (WC) ≥ 102/88 cm for men and women respectively.
• HDL cholesterol \<40 mg/dl in men and \<50 mg/dl in women or on specific drug therapy.
• Plasma Triglycerides ≥ 150 mg/dl or on specific drug therapy.
• Blood pressure ≥130 and/or ≥ 85 or on specific anti-hypertensive therapy.
• Fasting blood glucose ≥ 100 mg/dl or on specific anti hyperglycemic therapy
• Patients who agree to sign an informed consent
• Adult patients \>18 years old.
• Males and females
• Willing to comply with procedures and follow up
• Elevated serum transaminases (1-4 times the ULN)
• Imaging evidence of fatty liver:
• pelviabdominal ultrasound and Fibro- CAP study

You may not qualify if:

• Pregnancy or lactating
• Physical or mental abnormalities
• HCV infection
• HBV infection
• Anaemia
• Thrombocytopenia
• Haematological malignancies
• Ongoing alcoholism (Male: \>30g/day, Female: \>20g/day)
• Patients with renal failure
• Autoimmune hepatitis
• Celiac disease
• Wilson's disease
• Hemochromatosis
• Drugs: Tamoxifen, Valproic acid, Amiodarone, Methotrexate, Steroids, Anticoagulants, All anti-oxidative stress agents, Cos, IUD
• Chronic use of systematically immunosuppressive agent or drugs that can affect liver profile.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

National Hepatology and tropical medicine research institute

Cairo, Egypt

RECRUITING

Related Publications (11)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 19632207 BACKGROUND

• 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.

  PMID: 22408414 BACKGROUND

• 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.

  PMID: 24130601 BACKGROUND

• 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.

  PMID: 26156412 BACKGROUND

• Vrentzos E, Ikonomidis I, Pavlidis G, Katogiannis K, Korakas E, Kountouri A, Pliouta L, Michalopoulou E, Pelekanou E, Boumpas D, Lambadiari V. Six-month supplementation with high dose coenzyme Q10 improves liver steatosis, endothelial, vascular and myocardial function in patients with metabolic-dysfunction associated steatotic liver disease: a randomized double-blind, placebo-controlled trial. Cardiovasc Diabetol. 2024 Jul 10;23(1):245. doi: 10.1186/s12933-024-02326-8.

  PMID: 38987784 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Fatty Liver; Non-alcoholic Fatty Liver Disease; Inflammation; Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mariam Seif

CONTACT

+201112720114; mariam.talaat@pharma.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 9, 2023
• Study Start: October 31, 2023
• Primary Completion: July 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 26, 2025

Record last verified: 2025-03

Locations

EG (1)