## Protocol Section
### Identification Module
**NCT ID:** NCT06423287

**Acronym:** TRELO

**Brief Title:** Effects of TRE With Lactobacillus Plantarum LP-KFY04 Supplementation on Overweight / Obese Individuals

**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

#### Organization Study ID Info
**ID:** 2024LX0016_GY
#### Organization
**Class:** OTHER
**Full Name:** Zhujiang Hospital
### Status Module
#### Completion Date
**Date:** 2025-01-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-15

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-01-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-04-01

**Type:** ACTUAL

**Status Verified Date:** 2024-03

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-15
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Zhujiang Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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 Module

**Conditions:**

- Obesity

**Keywords:**

- Obesity

- Time-restricted Diet

- Probiotic Compound LP-KFY04

- Weight Loss

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 160

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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 Names:**

- Dietary Supplement: Lactobacillus plantarum LP-KFY04

**Label:** Lactobacillus plantarum LP-KFY04

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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 Names:**

- Other: Take placebo in addition to the limited diet.

**Label:** placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Lactobacillus plantarum LP-KFY04

**Description:** 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.

**Name:** Lactobacillus plantarum LP-KFY04

**Type:** DIETARY_SUPPLEMENT

#### Intervention 2

**Arm Group Labels:**

- placebo

**Description:** 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.

**Name:** Take placebo in addition to the limited diet.

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Measure:** Change of body weight from baseline to 12 weeks after intervention

**Time Frame:** 12 weeks

#### Secondary Outcomes

**Measure:** Changes of BMI compared with baseline in subjects

**Time Frame:** 12 weeks

**Measure:** Changes of waist circumference compared with baseline in subjects

**Time Frame:** 12 weeks

**Measure:** Changes of body fat percentage (BF%) compared with baseline assessed by dual-energy X-ray absorptiometry (DEXA)

**Time Frame:** 12 weeks

**Measure:** Change of subjects' HOMA-IR compared with baseline

**Time Frame:** 12 weeks

**Measure:** Changes of blood pressure in subjects compared with baseline

**Time Frame:** 12 weeks

**Measure:** Changes of blood glucose in subjects compared with baseline

**Time Frame:** 12 weeks

**Description:** Blood lipids includes total cholesterol、triglyceride、LDL-c、HDL-c.

**Measure:** Changes of blood lipids in subjects compared with baseline

**Time Frame:** 12 weeks

**Description:** Species of intestinal microbial includes Firmicutes、Bacteroidetes、Proteobacteria、Actinobacteriota、Verrucomicrobia、Fusobacteria.

**Measure:** Changes of intestinal microbial composition compared with baseline in subjects

**Time Frame:** 12 weeks

**Description:** Proportion of intestinal microbial such as Firmicutes、Bacteroidetes、Proteobacteria、Actinobacteriota、Verrucomicrobia、Fusobacteria

**Measure:** Changes of intestinal microbial abundance compared with baseline in subjects

**Time Frame:** 12 weeks

**Description:** Plasma metabolite includes arachidonic acid 、betaine、glutathione and so on.

**Measure:** Changes of plasma metabolite compared with baseline in subjects

**Time Frame:** 12 weeks

**Measure:** The incidence of adverse events in two groups of subjects

**Time Frame:** 12 weeks

### Eligibility Module

**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

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** rubychq@163.com

**Name:** Hong Chen, MD

**Phone:** 13602759769

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Guangzhou

**Country:** China

**Facility:** Zhujiang Hospital of Southern Medical University

**State:** Guangdong

**Status:** RECRUITING

**Zip:** 510000

#### Overall Officials

**Official 1:**

**Affiliation:** Zhujiang Hospital

**Name:** Hong Chen, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000044343

- Term: Overnutrition

- ID: D000009748

- Term: Nutrition Disorders

- ID: D000001835

- Term: Body Weight

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12701

- Name: Obesity

- Relevance: LOW

- As Found: Unknown

- ID: M26186

- Name: Overweight

- Relevance: HIGH

- As Found: Overweight

- ID: M18102

- Name: Weight Loss

- Relevance: LOW

- As Found: Unknown

- ID: M5114

- Name: Body Weight

- Relevance: LOW

- As Found: Unknown

- ID: M25307

- Name: Overnutrition

- Relevance: LOW

- As Found: Unknown

- ID: M12684

- Name: Nutrition Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000050177

- Term: Overweight

### Intervention Browse Module - Browse Branches

- Abbrev: Ot

- Name: Other Dietary Supplements

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: T355

- Name: Acidophilus

- Relevance: HIGH

- As Found: Students

### Misc Info Module

- Version Holder: 2024-05-31
