Randomized trial to assess protein supplementation's impact on semaglutide-induced weight loss and muscle preservation

Obesity is a significant global health challenge, with pharmaceutical advancements like GLP-1 receptor agonists offering effective weight loss solutions. However, substantial weight reduction, particularly with rapid methods, often leads to undesirable muscle mass loss, which can negatively impact metabolic health and increase frailty. Optimizing weight loss strategies to preserve lean body mass is crucial. Dietary protein supplementation is a known strategy to support muscle protein synthesis, making it a promising adjunct to GLP-1RA therapy to mitigate sarcopenia during weight loss.

This randomized clinical trial (RCT) with a parallel design will enroll 120 overweight/obese participants (BMI ≥ 24 kg/m²) and 20 normal-weight controls. Overweight/obese participants are randomized into three groups for a 3-month intervention: 1) calorie-restricted balanced diet (CRD); 2) CRD + semaglutide; or 3) CRD + semaglutide with protein supplementation. The study includes a 6-month follow-up. Primary endpoints include changes in body weight, body composition (muscle loss), energy and glucose and lipid metabolism, and weight regain. Gut microbiota profiles, obesity phenotypes, and genetic backgrounds will also be analyzed.

This is a study protocol, and therefore, no results are available yet. The researchers aim to investigate the effects of dietary protein supplementation combined with semaglutide on several key outcomes. They will measure changes in body weight, aiming to determine if protein supplementation enhances the magnitude or quality of weight loss. They will also assess the impact on muscle loss, a common concern with significant weight reduction, and evaluate its influence on energy, glucose, and lipid metabolism. Furthermore, the study will explore factors like obesity phenotypes, gut microbiota profiles, and genetic backgrounds to understand their role in intervention efficacy. The ultimate goal is to provide evidence for optimizing individualized intervention strategies.

The primary objective is to determine if protein supplementation can improve weight loss outcomes and reduce muscle loss in overweight/obese individuals receiving semaglutide.