Actively Recruiting

Phase 2
Age: 18Years - 80Years
All Genders
ID05984745

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

Led by Ain Shams University · Updated on 2025-03-26

60

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Metabolic-dysfunction associated fatty liver disease (MAFLD) is a common liver condition linked to factors like ethnicity, genetics, metabolism, and the environment. It is increasingly prevalent worldwide and is especially common among people with type 2 diabetes. This study investigates whether high doses of coenzyme Q10, known for its antioxidant and anti-inflammatory properties, can improve inflammation and liver-related biochemical markers in patients with MAFLD. Participants in this study will be randomly assigned to one of two groups. One group will receive standard care, which includes lifestyle changes such as diet, weight loss, and physical activity. The other group will receive the standard care plus Coenzyme Q10 Forte400 mg daily (100 mg twice a day) for twelve weeks. This dose is higher than in previous studies and aims to better evaluate the effects of CoQ10 on liver health in MAFLD patients. During the study, participants will undergo assessments of liver steatosis using imaging at the start and after 12 weeks. Blood tests will measure inflammatory markers like tumor necrosis factor-alpha, liver enzymes, kidney function, and other biochemical indicators. Quality of life will also be assessed. The study will monitor changes from baseline to 12 weeks to understand the tolerability and effects of CoQ10 in this population, with total participation lasting about three months.

CONDITIONS

Brief Title

Effect of CoQ10 on the Outcome of MAFLD Patients

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults older than 18 years and up to 80 years old
  • Diagnosis of metabolic dysfunction-associated fatty liver disease (MAFLD) with at least three of five metabolic criteria
  • Waist circumference ≥ 102 cm for men or ≥ 88 cm for women
  • HDL cholesterol below 40 mg/dl in men or below 50 mg/dl in women or on specific drug therapy
  • Plasma triglycerides ≥ 150 mg/dl or on specific drug therapy
  • Blood pressure ≥ 130/85 mmHg or on anti-hypertensive therapy
  • Fasting blood glucose ≥ 100 mg/dl or on anti-hyperglycemic therapy
  • Elevated serum transaminases (1-4 times the upper limit of normal)
  • Imaging evidence of fatty liver via ultrasound and Fibro-CAP
  • Willingness to sign informed consent and comply with procedures and follow-up
Not Eligible

You will not qualify if you...

  • Pregnancy or breastfeeding
  • Physical or mental abnormalities
  • Infection with hepatitis C virus (HCV) or hepatitis B virus (HBV)
  • Anemia or thrombocytopenia
  • Blood cancers
  • Ongoing alcoholism (men >30g/day, women >20g/day)
  • Renal failure
  • Autoimmune hepatitis
  • Celiac disease
  • Wilson's disease
  • Hemochromatosis
  • Use of drugs like Tamoxifen, Valproic acid, Amiodarone, Methotrexate, Steroids, Anticoagulants, all anti-oxidative stress agents, contraceptive devices
  • Chronic use of systemic immunosuppressive agents or drugs affecting liver profile
  • Hypothyroidism or hyperthyroidism
  • History of bypass surgeries
  • Receiving total parenteral nutrition (TPN)

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 12 weeks

Participants take Coenzyme Q10 capsules twice daily for twelve weeks alongside standard care or receive standard care alone.

Visits at baseline and at 12 weeks

Trial Site Locations

Total: 1 location

1

National Hepatology and tropical medicine research institute

Cairo, Egypt

Actively Recruiting

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Research Team

M

Mariam Seif

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Evidence of NAFLD progression from steatosis to fibrosing-steatohepatitis using paired biopsies: implications for prognosis and clinical management.

Stuart McPherson, Tim Hardy, Elsbeth Henderson...

https://pubmed.ncbi.nlm.nih.gov/25477264

Global epidemiology of nonalcoholic fatty liver disease-Meta-analytic assessment of prevalence, incidence, and outcomes.

Zobair M Younossi, Aaron B Koenig, Dinan Abdelatif...

https://pubmed.ncbi.nlm.nih.gov/26707365

Mitochondrial dysfunction in obesity: potential benefit and mechanism of Co-enzyme Q10 supplementation in metabolic syndrome.

Md Ashraful Alam, Md Mahbubur Rahman

https://pubmed.ncbi.nlm.nih.gov/24932457

Coenzyme Q10 supplementation lowers hepatic oxidative stress and inflammation associated with diet-induced obesity in mice.

Florence M Sohet, Audrey M Neyrinck, Barbara D Pachikian...

https://pubmed.ncbi.nlm.nih.gov/19632207

The effect of co-enzyme q10 on acute liver damage in rats, a biochemical and pathological study.

Soheil Ashkani Esfahani, Elmira Esmaeilzadeh, Fereshte Bagheri...

https://pubmed.ncbi.nlm.nih.gov/24130601

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.

Farnaz Farsi, Majid Mohammadshahi, Pezhman Alavinejad...

https://pubmed.ncbi.nlm.nih.gov/26156412

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.

Emmanouil Vrentzos, Ignatios Ikonomidis, George Pavlidis...

https://pubmed.ncbi.nlm.nih.gov/38987784