Modified intermittent eating for weight loss

Effects of Modified Intermittent Eating Strategy on Weight Loss and Cardiometabolic Risk Factors in Obese Adults: a Randomized Clinical Trial

This study is testing a new eating plan that combines time-restricted eating and calorie cutting to see if it helps obese adults lose weight and improve their health over a year.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 225 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Nanfang Hospital, Southern Medical University (other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06302803 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-75 with a body mass index (BMI) between 28.0 and 45.0 kg/m2.

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

Why it matters

Potential benefit: If successful, this approach could offer an effective dietary strategy for weight loss and improved metabolic health in obese individuals.

How similar studies have performed: Other studies have shown promising results with intermittent fasting and time-restricted eating, suggesting potential success for this approach.

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 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.

Conditions: Obesity, Time restricted eating, Intermittent Fasting, Modified Intermittent Eating strategy, Calorie restriction, Weight loss