Modified Intermittent Eating on Weight Loss (INTEREST-3 Trial)

Launched by NANFANG HOSPITAL, SOUTHERN MEDICAL UNIVERSITY · Mar 4, 2024

Keywords

ClinConnect Summary

The INTEREST-3 Trial is studying different eating patterns to see how they can help people with obesity lose weight and improve their overall health. Specifically, the trial is looking at a method called modified time-restricted eating (mTRE), where participants eat within a certain number of hours for five days a week and fast for two days, compared to traditional calorie restriction (CR). The goal is to find out which method is more effective for weight loss and reducing health risks over a 12-month period.

To participate in this trial, individuals must be between 18 and 75 years old and have a body mass index (BMI) between 28 and 45, which indicates obesity. However, there are some important exclusions, such as people with diabetes, serious heart or kidney problems, or those who have had certain surgeries recently. Participants can expect to follow a specific eating plan and will be monitored throughout the study to track their progress. This trial is currently recruiting participants, and it aims to provide valuable information about effective strategies for weight management in obese adults.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Man or women aged 18-75 years;
• • 2. Body mass index (BMI)of 28.0 to 45.0 kg/m2;
• Exclusion Criteria:
• • 1. History of HIV, hepatitis B or C (self-report) or active pulmonary tuberculosis;
• • 2. Diagnosis of type 1 and type 2 diabetes;
• • 3. History of malignant tumors;
• • 4. Serious liver dysfunction or chronic kidney disease (AST or ALT \> 3 times the upper limit of normal, or eGFR\<30 ml/min/1.73 m2);
• • 5. History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 6 months;
• • 6. History of severe gastrointestinal diseases or gastrointestinal surgery in the past 12 months;
• • 7. History of Cushing's syndrome, hypothyroidism, acromegaly, hypothalamic obesity;
• • 8. Being a smoker or having been a smoker in the 3 months prior to their screening visit;
• • 9. Taking medications affecting weight or energy intake/energy expenditure in the last 6 months, including weight loss medications, antipsychotic drugs or other medications as determined by the study physician;
• • 10. Currently participating in weight loss programs or weight change in the past 3 months (\> 5% current body weight) ;
• • 11. Women who are pregnant or plan to become pregnant;
• • 12. Patients who cannot be followed for 24 months (due to a health situation or migration);
• • 13. Patients who are unwilling or unable to give informed consent.