Overview
With the improvement of the quality of life, multi-nutritional dietary intake today has provided people with a solid foundation for their health profiles. Time-restricted eating is found to be an effective method to prevent and control obesity, helping obese patients to lose weight in a way of reshaping the gut microbiota. Regulation of gut microbiota, as a valid weight-loss strategy, can be achieved by oral supplementation of probiotics. This study aims to evaluate the effectiveness of time-restricted eating combined with Lactobacillus Plantarum LP-KFY04 on overweight/obese population through a multi-center, randomized and double-blind clinical trial.
Description
With the improvement of the quality of life, multi-nutritional dietary intake today has provided people with a solid foundation for their health profiles. Time-restricted eating is found to be an effective method to prevent and control obesity, helping obese patients to lose weight in a way of reshaping the gut microbiota. Regulation of gut microbiota, as a valid weight-loss strategy, can be achieved by oral supplementation of probiotics. This study aims to evaluate the effectiveness of time-restricted eating combined with Lactobacillus Plantarum LP-KFY04 on overweight/obese population through a multi-center, randomized and double-blind clinical trial.Patients in the treatment group will be instructed to eat in an 8-hour time window (a set period of time decided by the patients) with supplementation of Lactobacillus plantarum LP-KFY04 over 12 weeks'trial.Patients in the control group will be instructed to eat in an 8-hour time window (a set period of time decided by the patients) with supplementation of placebo over 12 weeks' trial.
Eligibility
Inclusion Criteria:
- Men or women aged 18 to 65 years old
- BMI 24.0 to 40kg/m2
- 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:
- History of HIV, hepatitis B or C (self-report) or active pulmonary tuberculosis;
- Diagnosis of type 1 or type 2 diabetes and prescribing hypoglycemic therapy
- History of malignant tumors
- 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)
- History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction, or stroke) within the past 6 months
- History of serious gastrointestinal disease or gastrointestinal surgery within the past 12 months
- History of Cushing's syndrome, hypothyroidism, acromegaly, and hypothalamic obesity
- Smoking or have smoked within the past 3 months of the screening period
- Drinking alcohol or drinking more than 15 grams of alcohol per day within the past 3 months of the screening period
- 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
- Currently involving in a weight loss program or having significant weight change within the past 3 months (> 5% of current weight)
- Women who are pregnant or planning for pregnant
- Patients who are unable to complete 12-week follow-up (due to health conditions or immigration reasons)
- Patients who are unwilling or unable to provide informed consent