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

NCT06423287 | Recruiting

• 1 other identifier: 2024LX0016_GY
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Obesity; Time-restricted Diet; Probiotic Compound LP-KFY04; Weight Loss

Outcome Measures

Primary Outcomes (1)

• Change of body weight from baseline to 12 weeks after intervention

  12 weeks

Secondary Outcomes (11)

• 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

Study Arms (2)

Lactobacillus plantarum LP-KFY04

EXPERIMENTAL

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

placebo

PLACEBO COMPARATOR

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.

Interventions

Lactobacillus plantarum LP-KFY04 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.

Lactobacillus plantarum LP-KFY04

Take placebo in addition to the limited diet. 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.

placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women aged 18 to 65 years old
• BMI 24.0 to 40kg/m2
• 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)

You may not qualify if:

• History of HIV, hepatitis B or C (self-report) or active pulmonary tuberculosis;
• Diagnosis of type 1 or type 2 diabetes and prescribing hypoglycemic therapy
• History of malignant tumors
• 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)
• History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction, or stroke) within the past 6 months
• History of serious gastrointestinal disease or gastrointestinal surgery within the past 12 months
• History of Cushing's syndrome, hypothyroidism, acromegaly, and hypothalamic obesity
• Smoking or have smoked within the past 3 months of the screening period
• Drinking alcohol or drinking more than 15 grams of alcohol per day within the past 3 months of the screening period
• 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
• Currently involving in a weight loss program or having significant weight change within the past 3 months (\> 5% of current weight)
• Women who are pregnant or planning for pregnant
• Patients who are unable to complete 12-week follow-up (due to health conditions or immigration reasons)
• Patients who are unwilling or unable to provide informed consent

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Hong Chen, MD

  Zhujiang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hong Chen, MD

CONTACT

13602759769; rubychq@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: May 21, 2024
• Study Start: April 1, 2024
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: May 21, 2024

Record last verified: 2024-03

Locations

CN (1)