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.

Participants will complete one baseline visit, one telephone follow-up at Week 4, and two on-site follow-up visits at Weeks 12 and 24. The primary objective is to evaluate the effect of polydextrose gummies versus placebo on percentage change in body weight over 24 weeks. Secondary objectives include assessing changes in appetite and satiety ratings, body composition (including fat mass and lean mass), waist circumference, and several metabolic parameters such as fasting glucose, HbA1c, fasting insulin, lipid profile, liver enzymes, and blood pressure. Quality of life and gastrointestinal tolerability will also be evaluated using validated questionnaires. Clinical assessments will be performed under standardized conditions to reduce measurement variability.

The study has been designed to determine whether daily supplementation with polydextrose functional gummies provides additional benefits beyond standardized lifestyle advice for body weight reduction while maintaining an acceptable safety and tolerability profile. The results are expected to contribute evidence regarding the potential role of polydextrose as a nutritional strategy for weight management in adults with overweight or obesity.

Inclusion criteria

• Adults aged 18 to 70 years.
• Body mass index (BMI) between 25 and 39.9 kg/m² (overweight or obesity class I-II).
• Stable body weight (no change greater than 3%) in the 3 months before joining the study.
• Usually eat at least 2 meals per day.
• Able and willing to follow the study procedures for 24 weeks, attend all scheduled visits, and complete the required records.
• Willing and able to sign the informed consent form.

Exclusion criteria

• Type 2 diabetes with HbA1c greater than 7%, type 1 diabetes, or type 2 diabetes treated with multiple daily insulin injections.
• Treatment with SGLT2 inhibitors for diabetes, heart failure, or chronic kidney disease.
• Uncontrolled thyroid disease (TSH outside the normal range) or recent changes in thyroid medication in the last 3 months.
• Significant gastrointestinal disease (such as severe irritable bowel syndrome, Crohn's disease, or ulcerative colitis).
• History of bariatric surgery.
• Liver cirrhosis.
• Advanced chronic kidney disease (stage IV-V).
• Following a very low-calorie diet (less than 800 kcal/day).
• Alcohol dependence or heavy alcohol use that, in the investigator's opinion, could affect the study.
• Current or recent eating disorder.
• Planning to start or recently started a specific weight-loss diet different from the one recommended by the study endocrinology service.
• Currently taking or having taken in the last 3 months medicines that affect appetite or body weight (such as anorectic drugs, GLP-1 receptor agonists, chronic corticosteroids, antipsychotics, or fiber supplements).
• Pregnancy or breastfeeding.
• Women of childbearing potential who are trying to become pregnant or plan to become pregnant during the study.
• Known allergy or intolerance to any ingredient of the study gummies.
• History of severe gastrointestinal problems with fermentable fibers.