Effects of TRE With Lactobacillus Plantarum LP-KFY04 Supplementation on Overweight / Obese Individuals (TRELO)

Effects of Time-Restricted Eating With Lactobacillus Plantarum LP-KFY04 Supplementation on Overweight / Obese Individuals : A Multicenter, Randomized, Double-blind, Placebo-controlled 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.

Study Overview

• Status: Recruiting
• Conditions: Obesity
• Intervention / Treatment: Dietary supplement: Lactobacillus plantarum LP-KFY04; Other: Take placebo in addition to the limited diet.

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 Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hong Chen, MD; Phone Number: 13602759769; Email: rubychq@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Zhujiang Hospital of Southern Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: 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.
Placebo Comparator: 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.	Other: Take 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change of body weight from baseline to 12 weeks after intervention	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of BMI compared with baseline in subjects		12 weeks
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 blood lipids in subjects compared with baseline	Blood lipids includes total cholesterol、triglyceride、LDL-c、HDL-c.	12 weeks
Changes of intestinal microbial composition compared with baseline in subjects	Species of intestinal microbial includes Firmicutes、Bacteroidetes、Proteobacteria、Actinobacteriota、Verrucomicrobia、Fusobacteria.	12 weeks
Changes of intestinal microbial abundance compared with baseline in subjects	Proportion of intestinal microbial such as Firmicutes、Bacteroidetes、Proteobacteria、Actinobacteriota、Verrucomicrobia、Fusobacteria	12 weeks
Changes of plasma metabolite compared with baseline in subjects	Plasma metabolite includes arachidonic acid 、betaine、glutathione and so on.	12 weeks
The incidence of adverse events in two groups of subjects		12 weeks

Collaborators and Investigators

• Sponsor: Zhujiang Hospital
• Investigators: Principal Investigator: Hong Chen, MD, Zhujiang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: April 15, 2024
• First Submitted That Met QC Criteria: May 15, 2024
• First Posted (Actual): May 21, 2024

Study Record Updates

• Last Update Posted (Actual): May 21, 2024
• Last Update Submitted That Met QC Criteria: May 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Obesity; Weight Loss; Time-restricted Diet; Probiotic Compound LP-KFY04
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Overweight
• Other Study ID Numbers: 2024LX0016_GY

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No