The effect of a synbiotic (probiotic and prebiotic) supplementation on patients with Non-Alcoholic Fatty Liver Disease (NAFLD): A proof of concept study

Early Phase 1

Recruiting

Conditions: on-Alcoholic Fatty Liver Disease

Registration Number: SLCTR/2018/042

Lead Sponsor: Durdans Hospital, 3, Alfred place, Colombo 3

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: Not specified

Inclusion Criteria

Subjects who are diagnosed to have NAFLD by a medical officer or a medical consultant [based on hepatic ultrasonography and elevated levels (>1.5xUpper Limit) of alanine aminotransferase (ALT) concentration] and are referred to a registered Dietician & Nutritionist.

Age between 30-55 years

Exclusion Criteria

Subjects having other acute or chronic liver diseases of other etiologies (viral hepatitis, autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, hereditary haemochromatosis, Wilson's disease, drug induced liver injury; cholestasis).

Subjects who are pregnant and / or lactating

Subjects who have history of malignancy, history of significant alcohol consumption (>14 units/week for men, >7 units/week for females)

Subjects who are taking antibiotics, probiotics, vitamin, mineral, antioxidants, omega-3 or any other food supplements preceding enrollment

Subjects who are on treatment with vitamin E, statins within 3 months prior to the starting date of the research.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in levels of Aspartate Transaminase (AST), Alanine Transaminase (ALT) and Gamma Glutamyl Transpeptidase (GGT). [At the baseline of the study and at 8 weeks]<br>

Secondary Outcome Measures

Name	Time	Method
Change in weight and BMI. <br>Change in dietary measures (assessed using 24-h dietary recalls and semi quantitative food frequency questionnaire)<br>Change in physical activity ( assessed using Short Form of the International Physical Activity Questionnaire.<br> [At the baseline of the study and at 8 weeks]<br>