Effect of CoQ10 on the Outcome of MAFLD Patients

March 22, 2025 updated by: Mariam Talaat, Ain Shams University

Effect of Coenzyme Q10 on the Outcome of Metabolic Dysfunction-Associated Fatty Liver Disease Patients

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • National Hepatology and Tropical Medicine Research Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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):

  1. Waist circumference (WC) ≥ 102/88 cm for men and women respectively.
  2. HDL cholesterol <40 mg/dl in men and <50 mg/dl in women or on specific drug therapy.
  3. Plasma Triglycerides ≥ 150 mg/dl or on specific drug therapy.
  4. Blood pressure ≥130 and/or ≥ 85 or on specific anti-hypertensive therapy.

  5. 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

Exclusion Criteria:

  • 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.
  • Hypo/Hyper-thyroidism
  • Bypass surgeries
  • TPN (Total Parenteral Nutrition)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Patients will receive the standard conventional care which is mainly therapeutic life changes
Experimental: Test Group
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
Coenzyme Q10 in the form of soft gelatin capsules, each capsule containing 100 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in liver steatosis degree
Time Frame: Baseline and at 12 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in serum levels of liver transaminases (AST and ALT) 3 months post treatment with Coenzyme Q10
Time Frame: Baseline and at 12 weeks
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.
Baseline and at 12 weeks
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
TNF-α levels will be assessed in serum
Baseline and at 12 weeks
Change in the quality of life of MAFLD patients
Time Frame: Baseline and at 12 weeks
Quality of life will be assessed using the Chronic Liver Disease (CLD) questionnaire
Baseline and at 12 weeks
Study the drug's effect on kidney functions by measuring serum creatinine levels
Time Frame: Baseline and at 12 weeks
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
Baseline and at 12 weeks
Change in serum levels of cytokeratin-18 (CK-18) 3 months post treatment with Coenzyme Q10
Time Frame: Baseline and at 12 weeks
CK-18 levels will be assessed in serum
Baseline and at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2023

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

August 1, 2023

First Submitted That Met QC Criteria

August 8, 2023

First Posted (Actual)

August 9, 2023

Study Record Updates

Last Update Posted (Actual)

March 26, 2025

Last Update Submitted That Met QC Criteria

March 22, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CoQ10 in MAFLD Patients

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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