Obesity & OverweightDEXTRO-PESONCT07758387
Polydextrose Functional Gummies for Weight Management in Adults With Overweight or Obesity
A study testing Polydextrose Gummies in people with Obesity & Overweight, run by Nutris We Care About You S.L. at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity & Overweight
- What is being tested?
- Polydextrose Gummies
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteSpain
- Study dates
- 19 Oct 2026to 29 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Hospital Universitario Príncipe de Asturias
Alcalá de Henares, Madrid, 28805
Diana Barreira, +34918878100
About this study
Official title: 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 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.
Read more
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.
Read the detailed description
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 for its effectiveness in weight management is still limited and inconsistent, and further research is needed to confirm its clinical benefits.
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 (BMI). 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, glycated hemoglobin (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.
- Conditions
- Obesity & Overweight
- Being tested
- Polydextrose Gummies, Placebo Gummies
- Keywords
- Polydextrose, Dietary Fiber, Functional Gummies, Overweight, Obesity, Weight Management, Weight Loss, Satiety, Appetite, Body Composition, Placebo-Controlled Trial, Randomized Clinical Trial
- Medical subject headings
- Obesity, Overweight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polydextrose GummiesDietary 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 GummiesDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Polydextrose Gummies Group | Active comparator | Participants will receive functional gummies containing polydextrose for 24 weeks according to the protocol-defined stepwise dose-escalation schedule. Receives: Dietary Supplement: Polydextrose 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. Receives: Dietary Supplement: Placebo Gummies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight
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.
Measured: Baseline and Week 24
Secondary outcomes (13)
Subjective Appetite and Satiety Scores
Change in subjective feelings of hunger and fullness assessed using a 10-point Visual Analog Scale (VAS), where 0 indicates "no hunger" / "not full at all" and 10 indicates "maximum hunger" / "extremely full". Higher scores indicate greater hunger or greater satiety, depending on the item.
Measured: Baseline and weeks 4, 12, and 24
Fat Mass
Change in fat mass measured in kilograms and as a percentage of total body weight by bioelectrical impedance analysis (BIA). Body composition will be assessed under standardized conditions, including fasting, consistent hydration, the same time of day, and use of the same device. Negative values indicate a reduction in fat mass.
Measured: Baseline and week 24
Lean Body Mass
Change in lean body mass measured in kilograms and as a percentage of total body weight by bioelectrical impedance analysis (BIA). Body composition will be assessed under standardized conditions, including fasting, consistent hydration, the same time of day, and use of the same device. Positive values indicate an increase in lean body mass.
Measured: Baseline and Week 24
Body Mass Index (BMI)
Change in body mass index (BMI), calculated as weight (kg) divided by height (m) squared. Weight will be measured under standardized fasting conditions. Height will be measured at baseline. A negative change indicates a reduction in BMI.
Measured: Baseline and week 24
Waist Circumference
Change in waist circumference measured in centimeters using a standardized protocol. A negative change indicates a reduction in waist circumference.
Measured: Baseline, week 12, and week 24
Plasma Glucose
Change in fasting plasma glucose measured in mg/dL after an overnight fast. A negative change indicates a reduction in fasting glucose levels.
Measured: Baseline, week 12, and week 24
Glycated Hemoglobin (HbA1c)
Change in HbA1c measured as a percentage. A negative change indicates improvement in long-term glycemic control.
Measured: Baseline, week 12, and week 24
Fasting Insulin
Change in fasting insulin measured in µU/mL after an overnight fast. A negative change indicates a reduction in fasting insulin levels.
Measured: Baseline, week 12, and week 24
Lipid Profile
Change in total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, and triglycerides measured in mg/dL in fasting conditions. A negative change indicates a reduction in total cholesterol, LDL cholesterol, and triglycerides. For HDL cholesterol, a positive change indicates improvement.
Measured: Baseline, week 12, and week 24
Liver Enzymes
Change in alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma-glutamyl transferase (GGT) measured in U/L in fasting conditions. Reductions indicate improvement in liver enzyme levels.
Measured: Baseline, week 12, and week 24
Systolic and Diastolic Blood Pressure
Change in systolic and diastolic blood pressure measured in mmHg under standardized conditions. A negative change indicates a reduction in blood pressure.
Measured: Baseline, week 12, and week 24
Quality of Life Scores
Change in quality of life assessed using the 12-Item Short Form Health Survey (SF-12) questionnaire. Scores are transformed to physical and mental component summaries, with higher scores indicating better quality of life.
Measured: Baseline and week 24
Gastrointestinal Symptoms Scores
Change in gastrointestinal symptoms assessed using the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire. Higher scores indicate more severe gastrointestinal symptoms.
Measured: Baseline, week 4, week 12, and week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start19 Oct 2026 (estimated)
- Primary completion29 Oct 2027 (estimated)
- Study completion29 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nutris We Care About You S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07758387
- Sponsor's protocol ID
- DEXTRO-PESO
- Acronym
- DEXTRO-PESO
- Status last verified
- Aug 2026
- First submitted
- 6 Aug 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Svedlund J, Sjodin I, Dotevall G. GSRS--a clinical rating scale for gastrointestinal symptoms in patients with irritable bowel syndrome and peptic ulcer disease. Dig Dis Sci. 1988 Feb;33(2):129-34. doi: 10.1007/BF01535722.
PubMed 3123181Thompson SV, Hannon BA, An R, Holscher HD. Effects of isolated soluble fiber supplementation on body weight, glycemia, and insulinemia in adults with overweight and obesity: a systematic review and meta-analysis of randomized controlled trials. Am J Clin Nutr. 2017 Dec;106(6):1514-1528. doi: 10.3945/ajcn.117.163246. Epub 2017 Nov 1.
PubMed 29092878Saraiva A, Carrascosa C, Raheem D, Ramos F, Raposo A. Maltitol: Analytical Determination Methods, Applications in the Food Industry, Metabolism and Health Impacts. Int J Environ Res Public Health. 2020 Jul 20;17(14):5227. doi: 10.3390/ijerph17145227.
PubMed 32698373Roytio H, Ouwehand AC. The fermentation of polydextrose in the large intestine and its beneficial effects. Benef Microbes. 2014 Sep;5(3):305-13. doi: 10.3920/BM2013.0065.
PubMed 24736314Gibb RD, Sloan KJ, McRorie JW Jr. Psyllium is a natural nonfermented gel-forming fiber that is effective for weight loss: A comprehensive review and meta-analysis. J Am Assoc Nurse Pract. 2023 Aug 1;35(8):468-476. doi: 10.1097/JXX.0000000000000882.
PubMed 37163454Kellow NJ, Coughlan MT, Reid CM. Metabolic benefits of dietary prebiotics in human subjects: a systematic review of randomised controlled trials. Br J Nutr. 2014 Apr 14;111(7):1147-61. doi: 10.1017/S0007114513003607. Epub 2013 Nov 13.
PubMed 24230488Martinelli M, Walz F, Goni E, Passutti G, Osella C, Drago SR. Effects of puddings containing whey protein and polydextrose on subjective feelings of appetite and short-term energy intake in healthy adults. Int J Food Sci Nutr. 2017 Sep;68(6):733-741. doi: 10.1080/09637486.2017.1283394. Epub 2017 Jan 31.
PubMed 28139153Magkos F, Fraterrigo G, Yoshino J, Luecking C, Kirbach K, Kelly SC, de las Fuentes L, He S, Okunade AL, Patterson BW, Klein S. Effects of Moderate and Subsequent Progressive Weight Loss on Metabolic Function and Adipose Tissue Biology in Humans with Obesity. Cell Metab. 2016 Apr 12;23(4):591-601. doi: 10.1016/j.cmet.2016.02.005. Epub 2016 Feb 22.
PubMed 26916363Kaczmarczyk MM, Miller MJ, Freund GG. The health benefits of dietary fiber: beyond the usual suspects of type 2 diabetes mellitus, cardiovascular disease and colon cancer. Metabolism. 2012 Aug;61(8):1058-66. doi: 10.1016/j.metabol.2012.01.017. Epub 2012 Mar 7.
PubMed 22401879Jensen MD, Ryan DH, Apovian CM, Ard JD, Comuzzie AG, Donato KA, Hu FB, Hubbard VS, Jakicic JM, Kushner RF, Loria CM, Millen BE, Nonas CA, Pi-Sunyer FX, Stevens J, Stevens VJ, Wadden TA, Wolfe BM, Yanovski SZ; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; Obesity Society. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B):2985-3023. doi: 10.1016/j.jacc.2013.11.004. Epub 2013 Nov 12. No abstract available.
PubMed 24239920Ibarra A, Astbury NM, Olli K, Alhoniemi E, Tiihonen K. Effect of Polydextrose on Subjective Feelings of Appetite during the Satiation and Satiety Periods: A Systematic Review and Meta-Analysis. Nutrients. 2016 Jan 14;8(1):45. doi: 10.3390/nu8010045.
PubMed 26784221Hibberd AA, Yde CC, Ziegler ML, Honore AH, Saarinen MT, Lahtinen S, Stahl B, Jensen HM, Stenman LK. Probiotic or synbiotic alters the gut microbiota and metabolism in a randomised controlled trial of weight management in overweight adults. Benef Microbes. 2019 Mar 13;10(2):121-135. doi: 10.3920/BM2018.0028. Epub 2018 Dec 10.
PubMed 30525950Flood MT, Auerbach MH, Craig SA. A review of the clinical toleration studies of polydextrose in food. Food Chem Toxicol. 2004 Sep;42(9):1531-42. doi: 10.1016/j.fct.2004.04.015.
PubMed 15234083Blaak EE, Antoine JM, Benton D, Bjorck I, Bozzetto L, Brouns F, Diamant M, Dye L, Hulshof T, Holst JJ, Lamport DJ, Laville M, Lawton CL, Meheust A, Nilson A, Normand S, Rivellese AA, Theis S, Torekov SS, Vinoy S. Impact of postprandial glycaemia on health and prevention of disease. Obes Rev. 2012 Oct;13(10):923-84. doi: 10.1111/j.1467-789X.2012.01011.x. Epub 2012 Jul 11.
PubMed 22780564Chen Y, Ma L, Han Z, Xiong P. The global burden of disease attributable to high body mass index in 204 countries and territories: Findings from 1990 to 2019 and predictions to 2035. Diabetes Obes Metab. 2024 Sep;26(9):3998-4010. doi: 10.1111/dom.15748. Epub 2024 Jul 3.
PubMed 38957939
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07758387
- Acronym / sponsor ID
- DEXTRO-PESO / DEXTRO-PESO
- Conditions
- Obesity & Overweight
- Keywords
- Polydextrose, Dietary Fiber, Functional Gummies, Overweight, Obesity, Weight Management, Weight Loss, Satiety
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Nutris We Care About You S.L.Industry (pharma, biotech, devices)
- Study start
- 19 Oct 2026 (estimated)
- Primary completion
- 29 Oct 2027 (estimated)
- Study completion
- 29 Oct 2027 (estimated)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 for its effectiveness in weight management is still limited and inconsistent, and further research is needed to confirm its clinical benefits.
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 (BMI). 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, glycated hemoglobin (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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Polydextrose Gummies Group | Active comparator | Dietary Supplement: Polydextrose GummiesParticipants will receive functional gummies containing polydextrose for 24 weeks according to the protocol-defined stepwise dose-escalation schedule. |
| Placebo Gummies Group | Placebo comparator | Dietary Supplement: Placebo GummiesParticipants will receive matching placebo gummies without polidextrose for 24 weeks according to the protocol-defined stepwise dose-escalation schedule. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polydextrose GummiesParticipants 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. | Dietary supplement | Polydextrose Gummies Group |
| Placebo GummiesParticipants 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. | Dietary supplement | Placebo Gummies Group |
Primary outcome
Body Weight
Time frame: Baseline 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.
13 secondary outcomes
Subjective Appetite and Satiety Scores
Time frame: Baseline and weeks 4, 12, and 24
Fat Mass
Time frame: Baseline and week 24
Lean Body Mass
Time frame: Baseline and Week 24
Body Mass Index (BMI)
Time frame: Baseline and week 24
Waist Circumference
Time frame: Baseline, week 12, and week 24
Plasma Glucose
Time frame: Baseline, week 12, and week 24
Glycated Hemoglobin (HbA1c)
Time frame: Baseline, week 12, and week 24
Fasting Insulin
Time frame: Baseline, week 12, and week 24
Lipid Profile
Time frame: Baseline, week 12, and week 24
Liver Enzymes
Time frame: Baseline, week 12, and week 24
Systolic and Diastolic Blood Pressure
Time frame: Baseline, week 12, and week 24
Quality of Life Scores
Time frame: Baseline and week 24
Gastrointestinal Symptoms Scores
Time frame: Baseline, week 4, week 12, and week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Background: PubMed 3123181Svedlund J, Sjodin I, Dotevall G. GSRS--a clinical rating scale for gastrointestinal symptoms in patients with irritable bowel syndrome and peptic ulcer disease. Dig Dis Sci. 1988 Feb;33(2):129-34. doi: 10.1007/BF01535722.
- Background: PubMed 29092878Thompson SV, Hannon BA, An R, Holscher HD. Effects of isolated soluble fiber supplementation on body weight, glycemia, and insulinemia in adults with overweight and obesity: a systematic review and meta-analysis of randomized controlled trials. Am J Clin Nutr. 2017 Dec;106(6):1514-1528. doi: 10.3945/ajcn.117.163246. Epub 2017 Nov 1.
- Background: PubMed 32698373Saraiva A, Carrascosa C, Raheem D, Ramos F, Raposo A. Maltitol: Analytical Determination Methods, Applications in the Food Industry, Metabolism and Health Impacts. Int J Environ Res Public Health. 2020 Jul 20;17(14):5227. doi: 10.3390/ijerph17145227.
- Background: PubMed 24736314Roytio H, Ouwehand AC. The fermentation of polydextrose in the large intestine and its beneficial effects. Benef Microbes. 2014 Sep;5(3):305-13. doi: 10.3920/BM2013.0065.
- Background: PubMed 37163454Gibb RD, Sloan KJ, McRorie JW Jr. Psyllium is a natural nonfermented gel-forming fiber that is effective for weight loss: A comprehensive review and meta-analysis. J Am Assoc Nurse Pract. 2023 Aug 1;35(8):468-476. doi: 10.1097/JXX.0000000000000882.
- Background: PubMed 24230488Kellow NJ, Coughlan MT, Reid CM. Metabolic benefits of dietary prebiotics in human subjects: a systematic review of randomised controlled trials. Br J Nutr. 2014 Apr 14;111(7):1147-61. doi: 10.1017/S0007114513003607. Epub 2013 Nov 13.
- Background: PubMed 28139153Martinelli M, Walz F, Goni E, Passutti G, Osella C, Drago SR. Effects of puddings containing whey protein and polydextrose on subjective feelings of appetite and short-term energy intake in healthy adults. Int J Food Sci Nutr. 2017 Sep;68(6):733-741. doi: 10.1080/09637486.2017.1283394. Epub 2017 Jan 31.
- Background: PubMed 26916363Magkos F, Fraterrigo G, Yoshino J, Luecking C, Kirbach K, Kelly SC, de las Fuentes L, He S, Okunade AL, Patterson BW, Klein S. Effects of Moderate and Subsequent Progressive Weight Loss on Metabolic Function and Adipose Tissue Biology in Humans with Obesity. Cell Metab. 2016 Apr 12;23(4):591-601. doi: 10.1016/j.cmet.2016.02.005. Epub 2016 Feb 22.
- Background: PubMed 22401879Kaczmarczyk MM, Miller MJ, Freund GG. The health benefits of dietary fiber: beyond the usual suspects of type 2 diabetes mellitus, cardiovascular disease and colon cancer. Metabolism. 2012 Aug;61(8):1058-66. doi: 10.1016/j.metabol.2012.01.017. Epub 2012 Mar 7.
- Background: PubMed 24239920Jensen MD, Ryan DH, Apovian CM, Ard JD, Comuzzie AG, Donato KA, Hu FB, Hubbard VS, Jakicic JM, Kushner RF, Loria CM, Millen BE, Nonas CA, Pi-Sunyer FX, Stevens J, Stevens VJ, Wadden TA, Wolfe BM, Yanovski SZ; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; Obesity Society. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B):2985-3023. doi: 10.1016/j.jacc.2013.11.004. Epub 2013 Nov 12. No abstract available.
- Background: PubMed 26784221Ibarra A, Astbury NM, Olli K, Alhoniemi E, Tiihonen K. Effect of Polydextrose on Subjective Feelings of Appetite during the Satiation and Satiety Periods: A Systematic Review and Meta-Analysis. Nutrients. 2016 Jan 14;8(1):45. doi: 10.3390/nu8010045.
- Background: PubMed 30525950Hibberd AA, Yde CC, Ziegler ML, Honore AH, Saarinen MT, Lahtinen S, Stahl B, Jensen HM, Stenman LK. Probiotic or synbiotic alters the gut microbiota and metabolism in a randomised controlled trial of weight management in overweight adults. Benef Microbes. 2019 Mar 13;10(2):121-135. doi: 10.3920/BM2018.0028. Epub 2018 Dec 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polydextrose Gummies in people with Obesity & Overweight, run by Nutris We Care About You S.L. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Veronica Gallo, PhD in Food Science (+34692911819, vgallo@nutris.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Weight (time frame: Baseline and Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07758387, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.