Probiotic Intervention on Body Weight

What Was Tested

In this not phased trial, researchers set out to test Semaglutide for fat loss, obesity & body recomposition.

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.

It had four arms (groups): Control Group (placebo comparator), GLP-1RA Group (active comparator), Probiotic Group (experimental) and Healthy Comparators (other).

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

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

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

The registry classes the interventions as behavioral, dietary supplement and drug.

More on the Plan

In addition, 20 normal-weight participants will be recruited and receive 12-week weight maintenance nutritional and lifestyle interventions.

In addition, data from dietary intake, anthropometric measurements, body composition, behavior questionnaires, 14-day continuous glucose monitoring, and 14-day accelerometer-based physical activity and sleep monitoring will also be collected to characterize metabolic homeostasis.

During the interventions, participants will receive dietary advice, behavior guidance and nutritional and lifestyle education by dietitian and physicians.

App-connected wearable devices will be utilized to monitor their dietary intakes and an app-connected scale will be used to monitor their weight changes during interventions.

Who Took Part

Enrollment: 140 planned participants were the target.

It was open to people of any sex aged from 20 years up to 50 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Aged 20 to 50 years. Normal-weight participants: 18.5 kg/m² ≤ Body Mass Index (BMI) \< 24 kg/m². Overweight or obese participants:. Willingness to participate in this study and provide signed informed consent.

The full record lists 4 inclusion and 27 exclusion criteria; among the exclusions: abnormal metabolic indicators (meeting any one of the following criteria is grounds for exclusion):; waist circumference ≥ 90 cm for men or ≥ 85 cm for women; systolic blood pressure ≥ 130 mmhg or diastolic blood pressure ≥ 85 mmhg, or currently under antihypertensive treatment.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The fat loss, obesity & body recomposition participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

The Semaglutide group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Semaglutide study: the fat loss, obesity & body recomposition participants and staff both knew the treatment.

It started in 2025-06-10 with completion listed for 2026-12-30.

It ran at 1 site in China.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Change in Body Weight (kg) from Baseline to Week 12 (time frame: Baseline and Week 12).

It also tracked 36 secondary outcomes, for example Change in Energy Expenditure Rate (kcal/min) from Baseline to Week 12, Change in Respiratory Quotient from Baseline to Week 12, Change in Fat Oxidation Rate (g/min) from Baseline to Week 12, Change in Carbohydrate Oxidation Rate (g/min) from Baseline to Week 12, Change in Waist Circumference (cm) from Baseline to Week 12 and Change in Hip Circumference (cm) from Baseline to Week 12.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Semaglutide in 140 people with fat loss, obesity & body recomposition.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, Fat loss, obesity & body recomposition research.