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

NCT07758387 | Not Yet Recruiting

• 1 other identifier: DEXTRO-PESO
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity & Overweight

Keywords

Polydextrose; Dietary Fiber; Functional Gummies; Overweight; Obesity; Weight Management; Weight Loss; Satiety; Appetite; Body Composition; Placebo-Controlled Trial; Randomized Clinical Trial

Outcome Measures

Primary Outcomes (1)

• Percentage Change in Body Weight From Baseline to 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.

  Baseline and Week 24

Secondary Outcomes (13)

• Change From Baseline in Subjective Appetite and Satiety Scores at Weeks 4, 12, and 24

  Baseline and weeks 4, 12, and 24

• Change in Fat Mass (kg and %) From Baseline to Week 24

  Baseline and week 24

• Change in Lean Body Mass (kg and %) From Baseline to Week 24

  Baseline and Week 24

• Change From Baseline in Body Mass Index (BMI) at Week 24

  Baseline and week 24

• Change From Baseline in Waist Circumference at Weeks 12 and 24

  Baseline, week 12, and week 24

Study Arms (2)

Polydextrose Gummies Group

ACTIVE COMPARATOR

Participants will receive functional gummies containing polydextrose for 24 weeks according to the protocol-defined stepwise dose-escalation schedule.

Dietary Supplement: Polidextrose Gummies

Placebo Gummies Group

PLACEBO COMPARATOR

Participants will receive matching placebo gummies without polidextrose for 24 weeks according to the protocol-defined stepwise dose-escalation schedule.

Dietary Supplement: Placebo Gummies

Interventions

Polidextrose 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 (approximately 13.5 g of polydextrose per day) to 2 gummies before each meal (approximately 27 g/day). From week 4 onwards, participants with good gastrointestinal tolerability will increase to 3 gummies before each meal (approximately 40.5 g/day), 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 15-30 minutes before meals, preferably with a glass of water.

Polydextrose Gummies Group

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 (approximately 6 g of maltitol per day) to 2 gummies before each meal (approximately 12 g/day). From week 4 onwards, participants with good gastrointestinal tolerability will increase to 3 gummies before each meal (approximately 18 g/day), 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 15-30 minutes before meals, preferably with a glass of water. All participants will also receive standard dietary and physical activity recommendations.

Placebo Gummies Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nutris We Care About You S.L.: lead

Study Sites (1)

Hospital Universitario Príncipe de Asturias

Alcalá de Henares, Madrid, 28805, Spain

Location

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MeSH Terms

Conditions

Obesity; Overweight; Weight Loss

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Central Study Contacts

Veronica Gallo, PhD in Food Science

CONTACT

+34692911819; vgallo@nutris.es

Pedro De la Fuente Blasco, MSc

CONTACT

+34696799589; pdelafuente@nutris.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a randomized, double-blind, placebo-controlled study. Individual unblinding will only be permitted when knowledge of the assigned treatment is essential for the clinical assessment or medical management of a serious adverse event or a suspected unexpected serious adverse reaction, as specified in the study protocol.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups receiving either polydextrose gummies or matching placebo gummies for 24 weeks. Both groups will follow the same stepwise dose-escalation schedule based on gastrointestinal tolerability, together with standardized dietary and physical activity recommendations.

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: August 11, 2026
• Study Start (Estimated): October 19, 2026
• Primary Completion (Estimated): October 29, 2027
• Study Completion (Estimated): October 29, 2027
• Last Updated: August 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)