Effects of TRE With Lactobacillus Plantarum LP-KFY04 Supplementation on Overweight / Obese Individuals

Launched by ZHUJIANG HOSPITAL · May 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a combination of time-restricted eating and a specific probiotic called Lactobacillus Plantarum LP-KFY04 to see how well it helps overweight and obese individuals lose weight. Time-restricted eating means you eat within a certain time window each day, which can help improve your gut health and support weight loss. The researchers want to find out if adding this probiotic will make the weight loss even more effective.

To join the study, participants need to be between 18 and 65 years old and have a Body Mass Index (BMI) between 24 and 40, which indicates being overweight or obese. They should be willing to commit to the trial and follow its guidelines. However, people with certain health issues, like diabetes, serious heart conditions, or liver and kidney problems, as well as those who smoke or drink heavily, won't be eligible. If you take part, you'll be closely monitored for 12 weeks to see how this approach affects your weight and overall health.

Gender

ALL

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

Trial Officials