Polydextrose Functional Gummies for Weight Management in Adults With Overweight or Obesity

Overweight and obesity are major public health challenges associated with an increased risk of type 2 diabetes, cardiovascular disease, metabolic dysfunction, and reduced quality of life. In this context, dietary and lifestyle interventions represent a first-line strategy for the management of overweight and the prevention of associated comorbidities, as they can induce favorable metabolic changes and improvements in vascular risk factors even when weight loss is modest. Within this framework, modulation of appetite and energy intake through functional ingredients such as dietary fibers has gained particular interest.

Polydextrose is a soluble, partially fermentable dietary fiber that resists digestion in the upper gastrointestinal tract and undergoes partial fermentation by the colonic microbiota. Proposed mechanisms of action include delayed gastric emptying, stimulation of satiety-related gut hormones such as glucagon-like peptide-1 (GLP-1), modulation of postprandial glycemic responses, and favorable effects on gut microbiota composition. However, evidence regarding its effectiveness for weight management remains limited and heterogeneous, and additional well-designed randomized controlled trials are needed to further establish its clinical efficacy.

This study is a single-center, randomized, double-blind, placebo-controlled, parallel-group clinical trial. Adult participants with overweight or class I-II obesity will be randomly assigned to receive either functional gummies containing polydextrose or matching placebo gummies for 24 weeks. Randomization will be performed using a block randomization procedure stratified by age, sex, and body mass index. Participants, investigators, and study personnel involved in clinical assessment will remain blinded to treatment allocation throughout the study.

Both study groups will receive the same standardized lifestyle recommendations, including dietary counseling based on healthy Mediterranean dietary principles and guidance to maintain habitual physical activity throughout the intervention period. Participants will also receive specific instructions to avoid consuming additional foods containing polydextrose outside the study products in order to minimize potential confounding and maintain treatment blinding. Compliance will be reinforced throughout follow-up using participant diaries, structured interviews, and product accountability procedures.

Study gummies will be consumed approximately 15 to 30 minutes before each main meal (breakfast, lunch, and dinner), and the daily dose will be gradually increased during the first weeks according to gastrointestinal tolerability, up to a maximum of three gummies before each meal in participants with good tolerability.