An interventional study of Polydextrose Gummies and Placebo Gummies in Obesity & Overweight, sponsored by Nutris We Care About You S.L.. Not yet recruiting at 1 site in Spain. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by Nutris We Care About You S.L. · Not applicable, Interventional, and Treatment
Among 387 studies in Obesity with a site in Spain — 92 open to participants now, 131 under way, 43 of them phase 3. Obesity · Spain.
Among the 387 studies in Obesity with a site in Spain, this one is the 201st largest by planned enrollment of the 329 interventional ones that give a count, is one of 40 that started in 2026, is one of 219 with no phase, reaches primary completion later than 77 of the 130 other live ones, and was the 376th registered.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
Browse Obesity studies →92 of the 387 studies in Obesity with a site in Spain are open now. Recruiting first, the newest first:
Eli Lilly and Company · Sites in Spain, United States, Brazil and 7 more countries
Eli Lilly and Company · Sites in Spain, United States, Belgium and 7 more countries
AstraZeneca · Sites in Spain, United States, Argentina and 13 more countries
Novo Nordisk A/S · Sites in Spain, United States, Belgium and 7 more countries
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud · Sites in Spain
A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →
Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 168 take children under 18; 491 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
387 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 24 · Phase 3 79 · Phase 4 7
First in 2001; this study’s year is marked. 40 started in 2026.
This study's planned enrollment of 96 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Median enrollment 123 across the 329 interventional studies, 128 across the 57 observational. Of the 208 that completed or were terminated, 25 (12%) have results posted.
This tab as a report to print or save as PDF → With an account.
119 of 387 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Nutris We Care About You S.L. as lead sponsor.
Nutris We Care About You S.L. has 1 study filed under Obesity — fewer than ten, so there is no comparison to draw.
31 of the studies in Obesity with a site in Spain that are under way reach primary completion within a year, 12 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06914895Phase 3Eli Lilly and CompanyA Study of Tirzepatide (LY3298176) Compared With Placebo in Adults With Type 1 Diabetes and Obesity or Overweight | 2026-11 |
| NCT06962280Phase 3Eli Lilly and CompanyA Long-Term Study of Tirzepatide (LY3298176) in Adults With Type 1 Diabetes and Obesity or Overweight | 2026-11 |
| NCT07332273Phase 3Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y SaludLevothyroxine as Adjuvant to a Hypocaloric Diet for the Treatment of Obesity. | 2026-11 |
| NCT06858839Phase 3AmgenEvaluation of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight | 2027-01-21 |
| NCT06672549Phase 3Eli Lilly and CompanyA Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040) | 2027-02 |
Among the 387 studies in Obesity with a site in Spain, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive functional gummies containing polydextrose for 24 weeks according to the protocol-defined stepwise dose-escalation schedule.
Dietary Supplement: Polydextrose Gummies
Participants will receive matching placebo gummies without polidextrose for 24 weeks according to the protocol-defined stepwise dose-escalation schedule.
Dietary Supplement: Placebo Gummies
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.
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.
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.
Time frame: Baseline and Week 24
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, week 4, week 12, and week 24
Plan to share: No
Start is estimated for Oct 2026; primary completion for Oct 2027, 12 months later.
Of 163 industry-sponsored interventional studies with no phase under Obesity, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 27. This study's planned 12 months is close to that.
Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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