Probiotic Intervention on Body Weight

NCT06989177 | Recruiting

• 1 other identifier: HIAS-PITBW-202503
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized controlled trial with 120 overweight or obese (body-mass index, BMI, ≥ 24 kg/m²) participants and 20 normal-weight participants. Twelve weeks of energy-restricted nutritional and lifestyle intervention with placebo, Lactobacillus paracasei LC-19 (LC-19), or semaglutide (a glucagon-like peptide-1 receptor agonist, GLP-1RA) will be randomly conducted in the overweight or obese participants. The primary goal is to clarify the roles of LC-19 and semaglutide in weight reduction and in improving energy, glucose, and lipid metabolism, while also comparing side effects, adverse events, and long-term outcomes such as weight regain between these two interventions. In addition, the study will explore key factors affecting intervention response to provide evidence for optimizing individualized intervention strategies.

Conditions

Obesity; Homeostasis; Weight Loss; Probiotic Intervention

Outcome Measures

Primary Outcomes (1)

• Change in Body Weight (kg) from Baseline to Week 12

  The change between the baseline and after 12-week intervention. Weight will be assessed using a Seca 255 scale (ScalesGalore).

  Baseline and Week 12

Secondary Outcomes (36)

• Change in Energy Expenditure Rate (kcal/min) from Baseline to Week 12

  Baseline and Week 12

• Change in Respiratory Quotient from Baseline to Week 12

  Baseline and Week 12

• Change in Fat Oxidation Rate (g/min) from Baseline to Week 12

  Baseline and Week 12

• Change in Carbohydrate Oxidation Rate (g/min) from Baseline to Week 12

  Baseline and Week 12

• Change in Waist Circumference (cm) from Baseline to Week 12

  Baseline and Week 12

Study Arms (4)

Control Group

PLACEBO COMPARATOR

They will receive energy-restricted nutritional and lifestyle intervention and placebo

Behavioral: Energy-restricted nutritional and lifestyle intervention; Dietary Supplement: Placebo

GLP-1RA Group

ACTIVE COMPARATOR

They will receive an energy-restricted nutritional and lifestyle intervention , in conjunction with prescribed semaglutide therapy.

Behavioral: Energy-restricted nutritional and lifestyle intervention; Drug: semaglutide

Probiotic Group

EXPERIMENTAL

They will receive an energy-restricted nutritional and lifestyle intervention and LC-19

Behavioral: Energy-restricted nutritional and lifestyle intervention; Dietary Supplement: Probiotic

Healthy Comparators

OTHER

They will receive general lifestyle and nutritional education.

Behavioral: General lifestyle and nutritional education

Interventions

General lifestyle and nutritional education BEHAVIORAL

Participants will receive dietary advice, behavior guidance and nutritional and lifestyle education based on dietary guidelines.

Healthy Comparators

Energy-restricted nutritional and lifestyle intervention BEHAVIORAL

Participants will receive dietary advice, behavioral guidance and nutritional and lifestyle education by dietitian and physicians. App-connected wearable devices will be utilized to monitor their dietary intakes and App-connected scale will be used to monitor their weight changes during interventions.

Control Group; GLP-1RA Group; Probiotic Group

Placebo DIETARY_SUPPLEMENT

Participants will receive one bag (2 g; 1 × 10¹² CFU) daily of LC-19.

Control Group

Probiotic DIETARY_SUPPLEMENT

participants will receive daily one bag of LC-19 (10\^12 cfu/bag).

Probiotic Group

semaglutide DRUG

Participants will receive prescibed semaglutide therapy

GLP-1RA Group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 20 to 50 years.
• Normal-weight participants: 18.5 kg/m² ≤ Body Mass Index (BMI) \< 24 kg/m².
• Overweight or obese participants:
• BMI ≥ 28 kg/m², or 24 kg/m² ≤ BMI \< 28 kg/m² and a clinical diagnosis meeting semaglutide treatment indications (e.g., hyperglycemia, hypertension, dyslipidemia, fatty liver, obstructive sleep apnea, cardiovascular disease, etc.).
• Willingness to participate in this study and provide signed informed consent.

You may not qualify if:

• \. Normal weight (18.5 kg/m² ≤ BMI \< 24 kg/m²):
• Waist circumference ≥ 90 cm for men or ≥ 85 cm for women.
• Fasting glucose ≥ 6.1 mmol/L or 2-hour postprandial glucose ≥ 7.8 mmol/L, or a confirmed diagnosis of diabetes.
• Systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmHg, or currently under antihypertensive treatment.
• Fasting triglycerides (TG) ≥ 1.7 mmol/L; high-density lipoprotein cholesterol (HDL-C) \< 0.9 mmol/L in men or \< 1.0 mmol/L in women.
• \. Overweight or obese (BMI ≥ 24 kg/m²):
• Fasting plasma glucose \> 11.1 mmol/L or HbA1c \> 9%, or previously diagnosed diabetes, or currently using insulin or any antidiabetic medication.
• Blood pressure ≥ 160/100 mmHg, or clinically diagnosed stage 2 or stage 3 (moderate or severe) hypertension, or currently under antihypertensive treatment.
• Use of lipid-lowering drugs (e.g., fibrates, bile acid sequestrants, statins, PCSK9 inhibitors) within the past 3 months, or TG ≥ 5.7 mmol/L, or LDL ≥ 4.9 mmol/L.
• Pregnancy or lactation.
• Self-reported weight change of more than 5 kg within the 90 days prior to screening.
• Use of antibiotics, antimicrobials, or anti-inflammatory/analgesic salicylates (e.g., aspirin) within the 3 months prior to screening for 3 days or more.
• Use of estrogen therapy or other hormonal medications within the past 6 months.
• Use of GLP-1 receptor agonists or probiotics within the past 3 months.
• Heavy alcohol consumption (females \> 40 g/day, approximately 250 mL of huangjiu \[yellow rice wine\], or 1000 mL of beer, or 100 mL of liquor per day; males \> 80 g/day).

Sponsors & Collaborators

• Chinese Academy of Sciences: lead

Study Sites (1)

Hangzhou Institute for Advanced Study, University of Chinese Academy of Sciences

Hangzhou, Zhejiang, 310024, China

RECRUITING

MeSH Terms

Conditions

Obesity; Weight Loss

Interventions

Probiotics; semaglutide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Xu Lin, PhD

  Institute for Nutritional Sciecnes, CAS; Hangzhou Institute for Advanced Study, UCAS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wanhui Kang, PhD

CONTACT

+86 86081210; kangwanhui@ucas.ac.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 25, 2025
• Study Start: June 10, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

CN (1)