Coenzyme Q10 Forte® capsules: Coenzyme Q10 in the form of soft gelatin capsules, each capsule containing 100 mg
Study 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
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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)
Primary outcome measure(s)
Change in liver steatosis degree — 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.
Trial sites (1)
Facility
City
Region
Status
National Hepatology and tropical medicine research institute
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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