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

Obesity Clinical Trial

— TRELO  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06423287
• Other study ID #: 2024LX0016_GY
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: January 31, 2025

Study information

• Verified date: March 2024
• Source: Zhujiang Hospital
• Contact: Hong Chen, MD
• Phone: 13602759769
• Email: rubychq[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

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.

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.

Locations

Country	Name	City	State
China	Zhujiang Hospital of Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhujiang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of body weight from baseline to 12 weeks after intervention		12 weeks
Secondary	Changes of BMI compared with baseline in subjects		12 weeks
Secondary	Changes of waist circumference compared with baseline in subjects		12 weeks
Secondary	Changes of body fat percentage (BF%) compared with baseline assessed by dual-energy X-ray absorptiometry (DEXA)		12 weeks
Secondary	Change of subjects' HOMA-IR compared with baseline		12 weeks
Secondary	Changes of blood pressure in subjects compared with baseline		12 weeks
Secondary	Changes of blood glucose in subjects compared with baseline		12 weeks
Secondary	Changes of blood lipids in subjects compared with baseline	Blood lipids includes total cholesterol?triglyceride?LDL-c?HDL-c.	12 weeks
Secondary	Changes of intestinal microbial composition compared with baseline in subjects	Species of intestinal microbial includes Firmicutes?Bacteroidetes?Proteobacteria?Actinobacteriota?Verrucomicrobia?Fusobacteria.	12 weeks
Secondary	Changes of intestinal microbial abundance compared with baseline in subjects	Proportion of intestinal microbial such as Firmicutes?Bacteroidetes?Proteobacteria?Actinobacteriota?Verrucomicrobia?Fusobacteria	12 weeks
Secondary	Changes of plasma metabolite compared with baseline in subjects	Plasma metabolite includes arachidonic acid ?betaine?glutathione and so on.	12 weeks
Secondary	The incidence of adverse events in two groups of subjects		12 weeks