Tests coenzyme Q10 capsules in adults with fatty liver disease
Tests high-dose coenzyme Q10 capsules in adults with fatty liver disease.
Plain-language title generated from the registry record
Registry title: Effect of CoQ10 on the Outcome of MAFLD Patients
Key facts
- Where
- Cairo, EgyptSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT05984745, who can take part
Where in Egypt
- National Hepatology and tropical medicine research instituteCairo, EgyptTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ain Shams University
- Trial code
- NCT05984745
- Record updated
- 26 March 2025
- Original description
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.Read full original descriptionShow less
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
Inclusion: 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.
Exclusion: 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; HCV infection; HBV infection; Haematological malignancies; Patients with renal failure; Autoimmune hepatitis; Celiac disease; Wilson's disease; Pregnancy or lactating; Physical or mental abnormalities; Anaemia; Thrombocytopenia; Ongoing alcoholism (Male: >30g/day, Female: >20g/day); Hemochromatosis; Hypo/Hyper-thyroidism; Bypass surgeries; TPN (Total Parenteral Nutrition).