Non-Alcoholic Fatty Liver Disease
Conditions
Brief summary
A randomized, double blind, placebo controlled clinical trial to evaluate the efficacy and safety of MXP22 on liver health
Interventions
OTHERMXP22 (Probiotic and antioxidant capsule)
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
Sponsors
Vedic Lifesciences Pvt. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Sequentially numbered, sealed, opaque envelopes
Intervention model description
Randomized, Parallel Group, Placebo Controlled Trial
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Adult men and women aged more than equal to 30 and less than or equal to 60 years, diagnosed with NAFLD within last 2 years. 2. CAP scores more than equal to 248 and less than or equal to 270 dB/m indicating steatosis grade I/ II. 3. Non-alcoholics (little or no consumption of alcohol). 4. Willing to participate in the study with a signed and dated written consent. 5. Overweight and obese participant with BMI more than or equal to 25 kg/m2. 6. Having at least 3 of the following five metabolic risk factors: i Waist circumference: Men: more than or equal to102 cm (40.15 inches); Women more than or equal to 88 cm (34.65 inches). ii Triglycerides \>150 mg/dL. iii Blood pressure more than or equal to 130 mm Hg (systolic, SBP) and/or more than or equal to 85 mm Hg (diastolic, DBP). iv Fasting blood glucose more than or equal to 100 mg/ dl. v Low HDL level: Men: \< 40 mg/dL; Women: \< 50 mg/dL.
Exclusion criteria
1. Treatment of NAFLD for at least 3 months prior to the screening. 2. History of decompensated liver disease (ascites, encephalopathy, variceal bleeding). 3. Participants with liver cirrhosis, any concomitant liver disease. 4. Participants with systemic inflammatory disease or autoimmune disorders. 5. Participants with blood pressure Less than or equal to 160 mm Hg (systolic, SBP) and/or less than or equal to 95 mm Hg (diastolic, DBP). 6. Participants with Fasting blood glucose Less than or equal to 140 mg/ dl. 7. Participants with cardiopulmonary disease. 8. Heavy alcohol drinkers defined as follows: i For men, consuming more than 4 drinks on any day or more than 14 drinks/week ii For women, consuming more than 3 drinks on any day or more than 7 drinks/week 9. Participants with liver cancer - primary hepatocellular carcinoma or liver metastasis. 10. Participants with other systemic disorders of the heart, lungs, blood, and endocrine system, including thyroid dysfunction and Type I diabetes mellitus. 11. Histologic evidence of NASH with fibrosis stage (METAVIR score) F1 or F4. 12. Individuals with Inflammatory bowel diseases. 13. Use of medications containing systemic steroids, methotrexate corticosteroids, amiodarone, tamoxifen, valproate, vitamin E, omega-3, Anti-retroviral agents; 1 month prior to screening. 14. Intake of probiotics (lactic acid bacteria, etc.), prebiotics (dietary fiber, fructooligo saccharide, etc.), new biotics, fermented milk and proton pump inhibitor within one month before screening or during the study period. 15. Participants who have hypersensitivity to the test drug/ placebo or components contained in the test drug/placebo or have severe allergic reactions. 16. Females who are breast-feeding, lactating, pregnant or intending to become pregnant. 17. Regular use of a probiotic or prebiotic supplement within 3 months prior to screening. 18. Antibiotic use within 3 weeks prior to screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fibroscan | Day 120. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AST & ALT | Day 0, 60 and 120 | Liver health as assessed by the significant change in the AST & ALT levels from baseline ascompared to that in placebo. |
| Lipid Profile | Day 0, 60 and 120 | 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. |
| Inflammatory markers | Day 0 and 120 | 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. |
| serum Lipopolysaccharide level | Day 0 and 120 | On dietary endotoxemia as assessed by the significant change in the serum Lipopolysaccharide level after a high fat diet |
| Fibroscan | [Time Frame: Day 0, Day 60 and Day 120 | 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. |
Countries
India
Outcome results
None listed