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Search / Trial NCT05453617

Intermittent Eating on Sustaining Weight-loss in Obesity

Launched by NANFANG HOSPITAL, SOUTHERN MEDICAL UNIVERSITY · Jul 6, 2022

Trial Information

Current as of August 19, 2025

Recruiting

Keywords

Obesity Time Restricted Eating The 5:2 Diet Weight Loss Maintenance

ClinConnect Summary

This clinical trial is studying two different eating patterns—known as intermittent fasting—that might help people maintain their weight loss after following a low-calorie diet. The two methods being tested are the 5:2 diet, where you eat normally for five days and limit yourself to about 500-800 calories on two days, and time-restricted eating (TRE), where you eat only during a specific time window each day (usually 4 to 10 hours) but don’t restrict the amount you eat during those hours. The goal is to see if these eating patterns can help people keep off the weight they lost and improve their overall health over a year.

You may be eligible to participate if you are between 18 and 75 years old and have a body mass index (BMI) between 28 and 45, which means you are considered obese. However, there are some health conditions that would prevent you from joining, such as having diabetes, certain heart diseases, or serious liver or kidney issues. If you choose to participate, you can expect to follow one of the eating patterns for a year while being monitored by the research team. It’s important to note that the study is currently recruiting participants and aims to help find effective ways to combat weight regain in obesity.

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.

About Nanfang Hospital, Southern Medical University

Nanfang Hospital, affiliated with Southern Medical University, is a leading medical institution in China renowned for its comprehensive clinical services and commitment to advancing healthcare through research and education. As a clinical trial sponsor, Nanfang Hospital leverages its state-of-the-art facilities and a multidisciplinary team of expert researchers to conduct innovative studies aimed at improving patient outcomes and contributing to the global medical community. The hospital's focus on ethical standards and patient safety ensures that all trials are conducted with the highest level of integrity and scientific rigor.

Locations

Guangzhou, Guangdong, China

Patients applied

GB

1 patients applied

Trial Officials

Huijie Zhang, MD. PhD.

Principal Investigator

Department of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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