Modified intermittent eating for weight loss

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effects of a modified time-restricted eating (mTRE) strategy combined with calorie restriction on weight loss and cardiometabolic risk factors in obese adults. Participants will follow a regimen of eating within a specified time frame for five days a week and restricting calorie intake for two days. The study aims to compare the outcomes of this dietary approach against usual health care over a 12-month period. By utilizing a randomized controlled design, the trial seeks to provide robust evidence on the effectiveness of this novel eating strategy.

Why it matters

Who can join: the full rules

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 it's running

• Nanfang Hospital of 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.
• Email: huijiezhang2005@126.com
• Phone: +86-020-61641635

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.