Effect of CoQ10 on the Outcome of MAFLD Patients
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAin Shams University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Pregnancy or lactating
Physical or mental abnormalities
HCV infection
HBV infection
Trial design
Design model
Parallel
Treatments tested in this trial
Coenzyme Q10 Forte® capsules
DrugCoenzyme Q10 in the form of soft gelatin capsules, each capsule containing 100 mg
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Control groupNo intervention 0 interventions
Group B: Test GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in liver steatosis degree
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.
Time frame
Baseline and at 12 weeksSecondary outcomes
1
Change in serum levels of tumor necrosis factor-alpha (TNF-α) 3 months post treatment with Coenzyme Q10
TNF-α levels will be assessed in serum
Time frame
Baseline and at 12 weeks2
Change in serum levels of cytokeratin-18 (CK-18) 3 months post treatment with Coenzyme Q10
CK-18 levels will be assessed in serum
Time frame
Baseline and at 12 weeks3
Change in serum levels of liver transaminases (AST and ALT) 3 months post treatment with Coenzyme Q10
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.
Time frame
Baseline and at 12 weeks4
Study the drug's effect on kidney functions by measuring serum creatinine levels
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
Time frame
Baseline and at 12 weeksSponsors and contacts
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Source ClinicalTrials.gov