Intervention on Metabolism and Related Chronic Diseases - Trial NCT06271200
Access comprehensive clinical trial information for NCT06271200 through Pure Global AI's free database. This phase not specified trial is sponsored by National Health Research Institutes, Taiwan and is currently Not yet recruiting. The study focuses on Metabolic Syndrome. Target enrollment is 120 participants.
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Study Focus
Sponsor & Location
National Health Research Institutes, Taiwan
Timeline & Enrollment
N/A
Feb 20, 2024
Dec 31, 2027
Primary Outcome
Change in the metabolic syndrome severity score (Z score) after reduction 5% body weight from baseline to 24 weeks
Summary
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06271200
Non-Device Trial