NCT06302803 Modified Intermittent Eating on Weight Loss (INTEREST-3 Trial)
| NCT ID | NCT06302803 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nanfang Hospital, Southern Medical University |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 225 participants |
| Start Date | 2024-04-07 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 225 participants in total. It began in 2024-04-07 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Calorie restriction (CR) is the most important treatment for weighting loss. In recent years, two novel types of intermittent fasting recently have gained more attention: the 5:2 diet and time-restricted eating (TRE). TRE requires individuals to eat in a specified number of hours per day (typically 4 to 10 hours) without energy intake restriction. The 5:2 diet involves 5 feast days and 2 fast days per week; participants eat ad libitum without restriction on feast days while 25% of energy needs (approximately 500-800 kcal per day) are consumed on fast days. However, the effects of dietary strategy of intermittent fasting plus time-restricted eating (modified time-restricted eating: TRE 5 days and fasting 2days per week) on weight loss and cardiometabolic risk factors in obese adults have not been proved. This randomized controlled trial aimed to evaluate the effect of modified time-restricted eating (mTRE) and CR on weight loss and cardiometabolic risk factors in obese adults compared to usual health care over 12 months.
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.
Contact & Investigator
Huijie Zhang, MD. PhD.
PRINCIPAL INVESTIGATOR
Department of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University
Frequently Asked Questions
Who can join the NCT06302803 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06302803 currently recruiting?
Yes, NCT06302803 is actively recruiting participants. Contact the research team at huijiezhang2005@126.com for enrollment information.
Where is the NCT06302803 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06302803 clinical trial?
NCT06302803 is sponsored by Nanfang Hospital, Southern Medical University. The principal investigator is Huijie Zhang, MD. PhD. at Department of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University. The trial plans to enroll 225 participants.
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