NCT06271200

Intervention on Metabolism and Related Chronic Diseases

Effects of Intensive Lifestyle Interventions (ILI) on Weight Loss and Cardiometabolic Risks in Obese Adults With Metabolic Syndrome: A Randomized Clinical Trial
National Health Research Institutes, Taiwan·ClinicalTrials.gov·otherNot yet recruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Metabolic Syndrome
Drug/Device/Intervention
Intermittent fasting and 10,000 steps per day
Study type
Interventional
Intervention type
other
Sponsor & location
Primary sponsor
National Health Research Institutes, Taiwan
Location
Zhunan, Taiwan
Timeline & enrollment
Phase
N/A
Start date
Feb 20, 2024
End date
Dec 31, 2027
Enrollment
120 participants
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
Metabolic disordersMetabolic disorder, unspecifiedOther metabolic disordersOther specified metabolic disordersNutritional and metabolic disorders in diseases classified elsewhere
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06271200
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.