A randomized, double blind, placebo controlled clinical trial to evaluate the efficacy and safety of MXP22 on liver health
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
60
Dose: NLT 4 Billion CFU/Capsule Route: Oral Administration Regimen: 1 capsule to be taken once daily after lunch for 120 days
Dose: NLT 4 Billion CFU/Capsule Route: Oral Administration Regimen: 1 capsule to be taken once daily after lunch for 120 days
JNU institute of medical science and research
Jaipur, Rajashthan, India
Dr. Sudhir Maharshi Gastro clinic
Jaipur, Rajasthan, India
Fibroscan
To evaluate the effect of 120 days consumption of MXP22 on hepatic steatosis as assessed by the change in Controlled Attenuation Parameter score on fibroscan from baseline to the end of the study, as compared to that in placebo
Time frame: Day 120.
AST & ALT
Liver health as assessed by the significant change in the AST \& ALT levels from baseline ascompared to that in placebo.
Time frame: Day 0, 60 and 120
Lipid Profile
Lipid profile as assessed by the significant change in the total Cholesterol, HDL Cholesterol, LDL Cholesterol and Triglycerides from baseline to end point in comparison to the placebo.
Time frame: Day 0, 60 and 120
Inflammatory markers
The inflammatory factors as assessed by the change in Interlukins-6 and Tumour Necrosis Factor alpha from baseline to end point in comparison to the placebo.
Time frame: Day 0 and 120
serum Lipopolysaccharide level
On dietary endotoxemia as assessed by the significant change in the serum Lipopolysaccharide level after a high fat diet
Time frame: Day 0 and 120
Fibroscan
To evaluate the effect of 120 days consumption of MXP22 on hepatic steatosis as assessed by the change in Controlled Attenuation Parameter score on fibroscan from baseline to the end of the study, as compared to that in placebo.
Time frame: [Time Frame: Day 0, Day 60 and Day 120
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