Obesity
Conditions
Keywords
Obesity, Time-restricted Diet, Probiotic Compound LP-KFY04, Weight Loss
Brief summary
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.
Detailed 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.
Interventions
DIETARY_SUPPLEMENTLactobacillus plantarum LP-KFY04
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.
OTHERTake placebo in addition to the limited diet.
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.
Sponsors
Zhujiang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of body weight from baseline to 12 weeks after intervention | 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of waist circumference compared with baseline in subjects | 12 weeks | — |
| Changes of body fat percentage (BF%) compared with baseline assessed by dual-energy X-ray absorptiometry (DEXA) | 12 weeks | — |
| Change of subjects' HOMA-IR compared with baseline | 12 weeks | — |
| Changes of blood pressure in subjects compared with baseline | 12 weeks | — |
| Changes of blood glucose in subjects compared with baseline | 12 weeks | — |
| Changes of BMI compared with baseline in subjects | 12 weeks | — |
| Changes of intestinal microbial composition compared with baseline in subjects | 12 weeks | Species of intestinal microbial includes Firmicutes、Bacteroidetes、Proteobacteria、Actinobacteriota、Verrucomicrobia、Fusobacteria. |
| Changes of intestinal microbial abundance compared with baseline in subjects | 12 weeks | Proportion of intestinal microbial such as Firmicutes、Bacteroidetes、Proteobacteria、Actinobacteriota、Verrucomicrobia、Fusobacteria |
| Changes of plasma metabolite compared with baseline in subjects | 12 weeks | Plasma metabolite includes arachidonic acid 、betaine、glutathione and so on. |
| The incidence of adverse events in two groups of subjects | 12 weeks | — |
| Changes of blood lipids in subjects compared with baseline | 12 weeks | Blood lipids includes total cholesterol、triglyceride、LDL-c、HDL-c. |
Countries
China
Contacts
Primary ContactHong Chen, MD
Outcome results
None listed