Clinical trial NCT06423287: Effects of TRE With Lactobacillus Plantarum LP-KFY04 Supplementation on Overweight / Obese Individuals
Official title: Effects of Time-Restricted Eating With Lactobacillus Plantarum LP-KFY04 Supplementation on Overweight / Obese Individuals : A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Keywords: Obesity
Time-restricted Diet
Probiotic Compound LP-KFY04
Weight Loss
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2024-05-21
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of body weight from baseline to 12 weeks after intervention
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes of BMI compared with baseline in subjects
timeFrame: 12 weeks
measure: Changes of waist circumference compared with baseline in subjects
timeFrame: 12 weeks
measure: Changes of body fat percentage (BF%) compared with baseline assessed by dual-energy X-ray absorptiometry (DEXA)
timeFrame: 12 weeks
measure: Change of subjects' HOMA-IR compared with baseline
timeFrame: 12 weeks
measure: Changes of blood pressure in subjects compared with baseline
timeFrame: 12 weeks
measure: Changes of blood glucose in subjects compared with baseline
timeFrame: 12 weeks
measure: Changes of blood lipids in subjects compared with baseline
timeFrame: 12 weeks
measure: Changes of intestinal microbial composition compared with baseline in subjects
timeFrame: 12 weeks
measure: Changes of intestinal microbial abundance compared with baseline in subjects
timeFrame: 12 weeks
measure: Changes of plasma metabolite compared with baseline in subjects
timeFrame: 12 weeks
measure: The incidence of adverse events in two groups of subjects
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
Study officials:
affiliation: Zhujiang Hospital
name: Hong Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: