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

NCT ID: NCT06423287

Last Updated: 2024-05-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2025-01-31

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Lactobacillus plantarum LP-KFY04

Intervention Type: DIETARY_SUPPLEMENT

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

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.

Group Type: PLACEBO_COMPARATOR

Take placebo in addition to the limited diet.

Intervention Type: OTHER

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.

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 Type: DIETARY_SUPPLEMENT

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhujiang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hong Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Zhujiang Hospital

Locations

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hong Chen, MD

Role: CONTACT

rubychq@163.com

13602759769

Other Identifiers

2024LX0016_GY

Identifier Type: -

Identifier Source: org_study_id