Randomized Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Functional Gummies With Polydextrose Versus Placebo for Weight Control in Adults With Overweight or Obesity
Overweight and obesity are common conditions that increase the risk of metabolic and cardiovascular diseases. Polydextrose is a type of dietary fiber that may help increase feelings of fullness by influencing natural hormones involved in appetite regulation. It may also improve postprandial glycemic responses and modulate the gut microbiota. However, evidence for its effectiveness in weight management remains limited.
The purpose of this study is to evaluate the efficacy and safety of functional gummies containing polydextrose compared with placebo in adults with overweight or obesity. Participants will be randomly assigned to receive either polydextrose or placebo gummies for 24 weeks, together with standardized dietary and physical activity recommendations.
The main objective is to determine whether polydextrose gummies produce a greater percentage reduction in body weight than placebo after 24 weeks. The study will also evaluate appetite and satiety, body composition, waist circumference, metabolic parameters, quality of life, gastrointestinal symptoms, and the safety and tolerability of the study product.
The study hypothesis is that daily consumption of polydextrose functional gummies for 24 weeks will result in greater weight loss than placebo and may improve subjective feelings of appetite and satiety in adults with overweight or obesity.
A Study Evaluating the Effects of a High Viscosity Non-starch Polysaccharide (PolyGlycopleX® - PGX®) on Glycemic Control, Cardiometabolic Risk Factors and Weight Loss in Overweight and Obese Type II Diabetics