Effects of time-restricted eating with a probiotic on weight loss in overweight individuals

Effects of Time-Restricted Eating With Lactobacillus Plantarum LP-KFY04 Supplementation on Overweight / Obese Individuals : A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial

This study is testing if eating within an 8-hour window along with a probiotic can help overweight people lose weight and improve their gut health.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Zhujiang Hospital (Academic / other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06423287 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of time-restricted eating combined with the probiotic Lactobacillus Plantarum LP-KFY04 in overweight and obese individuals. Participants will follow an 8-hour eating window for 12 weeks, with one group receiving the probiotic and the other a placebo. The study is designed as a multi-center, randomized, and double-blind trial to ensure unbiased results. The aim is to assess how this dietary approach can reshape gut microbiota and contribute to weight loss.

Who should consider this trial

Good fit: Ideal candidates are men and women aged 18 to 65 with a BMI between 24.0 and 40 kg/m2.

Not a fit: Patients with a history of serious medical conditions such as diabetes, cardiovascular diseases, or gastrointestinal disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a novel method for weight loss and obesity management through dietary interventions.

How similar studies have performed: Other studies have shown promise in using time-restricted eating and probiotics for weight management, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

1. Men or women aged 18 to 65 years old
2. BMI 24.0 to 40kg/m2
3. Patients who are aware of the purpose of the trail, willing to participate in the trial and sign informed consent forms, and comply with all requirements (including those during follow-up and evaluation investigations)

Exclusion Criteria:

1. History of HIV, hepatitis B or C (self-report) or active pulmonary tuberculosis;
2. Diagnosis of type 1 or type 2 diabetes and prescribing hypoglycemic therapy
3. History of malignant tumors
4. Serious liver dysfunction or chronic kidney disease (aspartate aminotransferase (AST) or alanine transaminase (ALT) \> 3 times the upper limit of normal, or estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73 m2)
5. History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction, or stroke) within the past 6 months
6. History of serious gastrointestinal disease or gastrointestinal surgery within the past 12 months
7. History of Cushing's syndrome, hypothyroidism, acromegaly, and hypothalamic obesity
8. Smoking or have smoked within the past 3 months of the screening period
9. Drinking alcohol or drinking more than 15 grams of alcohol per day within the past 3 months of the screening period
10. Taking any medicine that may affect weight or metabolism within the past 6 months, including weight loss medications, antipsychotics, or other medications identified by the researchers
11. Currently involving in a weight loss program or having significant weight change within the past 3 months (\> 5% of current weight)
12. Women who are pregnant or planning for pregnant
13. Patients who are unable to complete 12-week follow-up (due to health conditions or immigration reasons)
14. Patients who are unwilling or unable to provide informed consent

Where this trial is running

Guangzhou, Guangdong

• Zhujiang Hospital of Southern Medical University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Hong Chen, MD — Zhujiang Hospital
• Study coordinator: Hong Chen, MD

Conditions Obesity; Time-restricted Diet; Probiotic Compound LP-KFY04; Weight Loss