Clinical trial

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

Opening soon · Not applicable · 1 countries · Registry ID NCT07758387

Opening soonNot applicableInterventional

What this study is about

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 for weight management 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 primary objective is to compare the percentage change in body weight over 24 weeks between participants receiving polydextrose gummies and those receiving placebo. 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 intake of polydextrose gummies for 24 weeks will lead to a greater reduction in body weight than placebo and may improve subjective feelings of appetite and satiety in adults with overweight or obesity.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 70 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity & Overweight

Full registry criteria

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 glycated hemoglobin (HbA1c) greater than 7%, type 1 diabetes, or type 2 diabetes treated with multiple daily insulin injections. * Treatment with sodium-glucose co-transporter-2 (SGLT2) inhibitors for diabetes, heart failure, or chronic kidney disease. * Uncontrolled thyroid disease \[thyroid-stimulating hormone (TSH) outside the normal range\] 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.

Treatments and study arms

Polydextrose Gummies

Dietary Supplement

Participants in the experimental group will consume the polydextrose gummies before each main meal (breakfast, lunch, and dinner) for 24 weeks. The daily dose will be gradually increased during the first week from 1 gummy before each meal to 2 gummies before each meal. From week 4 onwards, participants with good gastrointestinal tolerability will increase to 3 gummies before each meal, while those with acceptable tolerability will remain at 2 gummies before each meal. Participants with poor tolerability will be withdrawn from the study. The gummies will be taken approximately 15 to 30 minutes before meals, preferably with a glass of water. All participants will also receive standard dietary and physical activity recommendations.

Placebo Gummies

Dietary Supplement

Participants in the control group will consume matching placebo gummies without polydextrose before each main meal (breakfast, lunch, and dinner) for 24 weeks. The daily dose will be gradually increased during the first week from 1 gummy before each meal to 2 gummies before each meal. From week 4 onwards, participants with good gastrointestinal tolerability will increase to 3 gummies before each meal, while those with acceptable tolerability will remain at 2 gummies before each meal. Participants with poor tolerability will be withdrawn from the study. The gummies will be taken approximately 15 to 30 minutes before meals, preferably with a glass of water. All participants will also receive standard dietary and physical activity recommendations.

Primary outcomes

Body WeightBaseline and Week 24

Percentage change in total body weight from baseline to week 24, calculated as \[(weight at week 24 - baseline weight) / baseline weight\] × 100. Body weight will be measured in kilograms using a calibrated scale under standardized conditions. Negative values indicate weight loss, whereas positive values indicate weight gain.

Study locations

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Hospital Universitario Príncipe de Asturias🇪🇸 Alcalá de Henares, Madrid, Spain

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Diana BarreiraContact

Call +34918878100