NCT04004403.

Study name	AlternatedDay fasting combined and NAFLD for the treatment of Non‐alcoholic Fatty Liver Disease (NAFLD)
Methods	Randomised controlled trial
Participants	Inclusion Criteria ‐ Age between 18 to 65 years old ‐ BMI between 30.0 and 49.9 kg/m2 ‐ NAFLD (hepatic steatosis = 5%) ‐ Prediabetic ‐ Sedentary (<20 min, 2x/week of light activity for 3 mo prior to study) Exclusion Criteria ‐ Have chronic liver disease other than NAFLD (hepatitis B or C, primary biliary cirrhosis, sclerosing cholangitis, autoimmune hepatitis, haemochromatosis, Wilson's disease, a1‐antitrypsin deficiency) ‐ Consume excessive amounts of alcohol (Michigan Alcohol Screening Test score > 4) ‐ Have a history of known cardiovascular, pulmonary or renal disease ‐ Diagnosed T1DM or T2DM (fasting glucose: >126 mg/dl, 2‐h glucose OGTT = 200 mg/dL, HbA1c: >6.5%)) ‐ Have contraindications for participation in an exercise program based on ACSM recommendations ‐ Are not weight stable for 3 months prior to the beginning of study (weight gain or loss > 4 kg) ‐ Are claustrophobic or have implanted metallic/electrical devices (e.g. cardiac pacemaker, neuro‐stimulator) ‐ Are not able to keep a food diary or activity log for 7 consecutive days during screening ‐ Are taking drugs that induce steatosis (e.g. corticosteroids, oestrogens, methotrexate, Ca channel blockers) ‐ Are taking drugs that benefit NAFLD (e.g. betaine, pioglitazone, rosiglitazone, metformin, or gemifibrozil) ‐ Are taking drugs that influence study outcomes (weight loss, lipid‐lowering, glucose‐lowering medications) ‐ Are perimenopausal or have an irregular menstrual cycle (menses that does not appear every 27‐32 days) ‐ Are pregnant, or trying to become pregnant ‐ Are smokers
Interventions	Other: Alternate day fasting Other: Exercise
Outcomes	Change in body weight [Time Frame: Change from week 1 to week 24] Change in hepatic steatosis [Time Frame: Change from week 1 to week 24] Change in HbA1c [Time Frame: Change from week 1 to week 24] Change in hepatic insulin sensitivity [Time Frame: Change from week 1 to week 24] Change in triglyceride levels [Time Frame: Change from week 1 to week 24]
Starting date	28/06/2019
Contact information	https://clinicaltrials.gov/show/NCT04004403
Notes	NCT04004403