Intermittent eating methods for maintaining weight loss in obesity

Effects of Intermitting Eating on Weight-Loss Maintenance and Cardiometabolic Risk Factors in Obese Adults: A Randomized Clinical Trial

This study is testing two different intermittent fasting methods to see if they can help people who have lost weight keep it off and improve their health.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 270 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Nanfang Hospital, Southern Medical University (other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05453617 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of two intermittent fasting approaches, time-restricted eating (TRE) and the 5:2 diet, in maintaining weight loss and improving cardiometabolic health in obese adults. Participants who have lost at least 5% of their body weight after an initial low-calorie diet will be randomly assigned to one of three groups: TRE, the 5:2 diet, or a control group. The TRE group will eat within an 8-hour window daily, while the 5:2 group will consume a significantly reduced calorie intake on two designated fasting days each week. The study aims to assess the long-term impacts of these diets over a 12-month period compared to usual healthcare practices.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with a BMI between 28.0 and 45.0 kg/m2 who have successfully lost weight through a low-calorie diet.

Not a fit: Patients with a history of diabetes, serious cardiovascular diseases, or other significant health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide effective dietary strategies for long-term weight loss maintenance in obese individuals.

How similar studies have performed: Preliminary evidence suggests that similar intermittent fasting approaches have shown beneficial effects, but this specific comparison of TRE and the 5:2 diet for weight loss maintenance is novel.

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.

Where this trial is running

Guangzhou, Guangdong

• Nanfang Hospital, Southern Medical University — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Principal investigator: Huijie Zhang, MD. PhD. — Department of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University
• Study coordinator: Huijie Zhang, MD. PhD.

Conditions: Obesity, Time restricted eating, The 5:2 diet, Weight loss maintenance