Efficacy of structured exercise and oat supplementation for treating non-alcoholic fatty liver disease: protocol of a randomized controlled trial

Table 1 Schedule of assessments

Assessment	V0		V1	V2	V3	Early termination
Time point	Baseline (-14 ~ 0 day)		0 day	12 weeks ± 7 days	24 weeks ± 7 days
Informed consent	×
Inclusion/exclusion	×
Randomization			×
Demographic data	×
Physical examination^a	×			×	×	×
Medical history collection	×
History of allergies to this study ingredients	×
Concomitant medication	×
Dietary habits, smoking, and alcohol consumption survey	×
PAR-Q+	×
Laboratory examination^b	×			×	×	×
Hepatitis panel^c	×
Serum β - human cborionic gonadotropin test (for reproductive-age female)	×			×	×	×
72-hour dietary record	×			×	×	×
Electrocardiogram		Perform electrocardiogram when necessary
Abdominal QCT (intrahepatic content of lipid)	×			×	×	×
Body composition	×			×	×	×
Muscle strength^d
Gut flora and the gut hormone^e	×			×	×	×
Adherence				×	×	×
The occurrence of adverse events				×	×	×
Follow up summary				×	×	×

(a) Physical examination consists weight, waist-to-hip ratio and blood pressure. (b) Laboratory examination consists routine blood tests, haemoglobin A1c (HbA1c), fasting blood glucose (FBG), insulin, alanine aminotransferase (ALT)/aspartate aminotransferase (AST), serum creatinine, creatine kinase (CK), creatine kinase isoenzyme (CKMB), four serum lipid indices, bilirubin, urine routine, stool routine, faecal occult blood test. (c) Hepatitis panel consists hepatitis B surface antigen, hepatitis C antibody and hepatitis A antibody. (d) Muscle strength is evaluated in the form of grip strength, back strength and the 30-s seat test. (e) The gut hormone test consisted of glucagon-like peptide-1 (GLP-1), cholecystokinin (CCK), peptide tyrosine tyrosine (PYY) and ghrelin. Abbreviations: PAR-Q+: Physical Activity Readiness Questionnaire, QCT: quantitative computed tomography

ISSN: 1475-2891