Health TrialsbyHealthPanel

Probiotic Intervention on Body Weight

ConditionsObesityHomeostasisWeight LossProbiotic Intervention
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-50
SponsorChinese Academy of Sciences

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Aged 20 to 50 years.

Normal-weight participants: 18.5 kg/m² ≤ Body Mass Index (BMI) < 24 kg/m².

Willingness to participate in this study and provide signed informed consent.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • General lifestyle and nutritional education

    Behavioral

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

  • 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.

  • Placebo

    Dietary supplement

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

  • Probiotic

    Dietary supplement

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

  • semaglutide

    Drug

    Participants will receive prescibed semaglutide therapy

Treatment groups

140 Participants
are divided into 4 treatment groups
Group A: Control GroupPlacebo comparator 2 interventions
Group B: GLP-1RA GroupActive comparator 2 interventions
Group C: Probiotic GroupExperimental treatment 2 interventions
Group D: Healthy ComparatorsOther 1 intervention

Trial outcomes

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).

Time frame
Baseline and Week 12

Secondary outcomes

1

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

The change from baseline to after the 12-week intervention. Energy expenditure rate (kcal/min) will be assessed with a whole-room indirect calorimeter (Sable).

Time frame
Baseline and Week 12
2

Change in Respiratory Quotient from Baseline to Week 12

The change from baseline to after the 12-week intervention. Respiratory quotient will be assessed with a whole-room indirect calorimeter.

Time frame
Baseline and Week 12
3

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

The change from baseline to after the 12-week intervention. Fat oxidation rate (g/min) will be assessed with a whole-room indirect calorimeter.

Time frame
Baseline and Week 12
4

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

The change from baseline to after the 12-week intervention. Carbohydrate oxidation rate (g/min) will be assessed with a whole-room indirect calorimeter.

Time frame
Baseline and Week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chinese Academy of Sciences

Lead sponsor

Source ClinicalTrials.gov
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