Effects of Time-Restricted Eating With Lactobacillus Plantarum LP-KFY04 Supplementation on Overweight / Obese Individuals : A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Change of body weight from baseline to 12 weeks after intervention
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Lactobacillus 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.
Intervention: Lactobacillus plantarum LP-KFY04 (Dietary Supplement)
placebo
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.
Intervention: Take placebo in addition to the limited diet. (Other)
Outcomes
Primary Outcomes
Change of body weight from baseline to 12 weeks after intervention
Time Frame: 12 weeks
Secondary Outcomes
- Changes of waist circumference compared with baseline in subjects(12 weeks)
- Changes of intestinal microbial composition compared with baseline in subjects(12 weeks)
- Changes of BMI 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)
- Changes of blood pressure in subjects compared with baseline(12 weeks)
- Changes of blood lipids in subjects compared with baseline(12 weeks)
- Changes of plasma metabolite compared with baseline in subjects(12 weeks)
- The incidence of adverse events in two groups of subjects(12 weeks)
- Change of subjects' HOMA-IR compared with baseline(12 weeks)
- Changes of blood glucose in subjects compared with baseline(12 weeks)
- Changes of intestinal microbial abundance compared with baseline in subjects(12 weeks)