Effects of TRE With Lactobacillus Plantarum LP-KFY04 Supplementation on Overweight / Obese Indivi… (NCT06423287) | Clinical Trial Compass
UnknownNot Applicable
Effects of TRE With Lactobacillus Plantarum LP-KFY04 Supplementation on Overweight / Obese Individuals
China160 participantsStarted 2024-04-01
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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
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What they're measuring
1
Change of body weight from baseline to 12 weeks after intervention