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

May 15, 2024 updated by: Zhujiang Hospital

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhujiang Hospital

Investigators

  • Principal Investigator: Hong Chen, MD, Zhujiang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe