Probiotic Intervention on Body Weight

What this study is testing ClinicalTrials.gov NCT06989177 ↗

Description as written by the study sponsor.

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.

Treatments tested

• 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