Intervention on Metabolism and Related Chronic Diseases
Status: Not yet recruiting

This study is a randomized, parallel-group, observer-masked clinical trial. A total of 120 obese participants with MetS will be enrolled. Eligible subjects will be randomly assigned to the ILI group or ULI group with an allocation ratio of 2:1. The ILI group will be instructed to eat in 8 hours while fasting in 16 hours on daily basis over 24 weeks. Furthermore, enhanced daily physical activities with walking more than 10,000 steps will be implemented. The enrolled participants will be instructed to follow a diet with reduction of daily intake of 500 kcals per day. ILI group will be asked to use the Health2Sync mobile app to track self-measured outcomes and daily diet control. The investigators objectively measure step counts for participants of ILI group during 24-week intervention period using a wearable device (Fitbit Inspire 2). Participants are asked to attach the pedometer on their waist belt, except while bathing and sleeping. The ULI group will be instructed to follow habitual meal timing. In addition, all participants of both groups will receive the health education. Anthropometric, sociodemographic data, biochemical variables, and metabolic variables will be measured at baseline and during follow-up visit. DEXA and MRI of abdomen will be measured at baseline and during following up visits. The proposed trial is designed to provide 85% statistical power to detect a significant difference in changes in the metabolic syndrome severity score after reduction > 5% body weight over 24 weeks.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Men or women aged from ≥ 20 years to 65 years BMI 27.0 to 45.0 kg/m2 with metabolic syndrome by IDF definition  Exclusion Criteria:  History of HIV, hepatitis B or C (self-report) or active pulmonary tuberculosis Diagnosis of type 1 or type 2 diabetes and regular taking oral or injection hypoglycemic therapy History of malignant tumors with active managements. Serious liver dysfunction or chronic kidney disease (aspartate aminotransferase (AST) or alanine transaminase (ALT) > 3 times the upper limit of normal, or estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73 m2) History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 6 months History of severe gastrointestinal diseases or gastrointestinal surgery in the past 6 months History of Cushing's syndrome, hypothyroidism, acromegaly, hypothalamic obesity without regular managements. Taking medications affecting weight or energy intake/energy expenditure in the last 3 months, including weight loss medications, antipsychotic drugs or other medications as determined by the study physician Currently participating in weight loss programs or weight change in the past 3 months (>5% current body weight) Women who are pregnant or plan to become pregnant Patients who cannot be followed for 3 years (due to a health situation or migration) Patients who are unwilling or unable to give informed consent - HealthyVolunteers: No - Gender: All - MinimumAge: 20 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult