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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
160
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.
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
RECRUITINGChange of body weight from baseline to 12 weeks after intervention
Time frame: 12 weeks
Changes of BMI compared with baseline in subjects
Time frame: 12 weeks
Changes of waist circumference compared with baseline in subjects
Time frame: 12 weeks
Changes of body fat percentage (BF%) compared with baseline assessed by dual-energy X-ray absorptiometry (DEXA)
Time frame: 12 weeks
Change of subjects' HOMA-IR compared with baseline
Time frame: 12 weeks
Changes of blood pressure in subjects compared with baseline
Time frame: 12 weeks
Changes of blood glucose in subjects compared with baseline
Time frame: 12 weeks
Changes of blood lipids in subjects compared with baseline
Blood lipids includes total cholesterol、triglyceride、LDL-c、HDL-c.
Time frame: 12 weeks
Changes of intestinal microbial composition compared with baseline in subjects
Species of intestinal microbial includes Firmicutes、Bacteroidetes、Proteobacteria、Actinobacteriota、Verrucomicrobia、Fusobacteria.
Time frame: 12 weeks
Changes of intestinal microbial abundance compared with baseline in subjects
Proportion of intestinal microbial such as Firmicutes、Bacteroidetes、Proteobacteria、Actinobacteriota、Verrucomicrobia、Fusobacteria
Time frame: 12 weeks
Changes of plasma metabolite compared with baseline in subjects
Plasma metabolite includes arachidonic acid 、betaine、glutathione and so on.
Time frame: 12 weeks
The incidence of adverse events in two groups of subjects
Time frame: 12 weeks
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