Impact of CoQ10 on patients with fatty liver disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of Coenzyme Q10 (CoQ10) on patients diagnosed with metabolic-dysfunction associated fatty liver disease (MAFLD). The study aims to evaluate whether high doses of CoQ10 can reduce systemic inflammation and improve biochemical markers associated with the disease. Participants will undergo a thorough evaluation to confirm the presence of metabolic dysregulation criteria before receiving CoQ10 Forte® capsules. The trial is designed to provide insights into a potential new treatment option for this increasingly prevalent liver condition.

Why it matters

Who can join: the full rules

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)

Where it's running

• National Hepatology and tropical medicine research institute
  Cairo, Egypt Recruiting

Study contacts

• Study coordinator: Mariam Seif
• Email: mariam.talaat@pharma.asu.edu.eg
• Phone: +201112720114

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.