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Childhood ObesityPhase 4PolymetsNCT07321184

Effect of Polysaccharide-based Complex Administration on the Gut Microbiome and Cardio-Metabolic Profile in Children With Obesity and Metabolic Syndrome.

A Phase 4 study testing Polysaccharide-based complex in people with Childhood Obesity, run by University of Milan at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Childhood obesity is a growing public health concern and is associated with long-term health issues. Changing lifestyle habits, especially improving diet and maintaining these changes over time, can be challenging for children and families. Read more about this study

Who is it for?
Ages 8 to 14 years
Conditions the study is for
Childhood Obesity
What is being tested?
Polysaccharide-based complex
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteItaly
Study dates
1 Feb 2022to 30 Nov 2024
Phase
Phase 4
Are there results?
None posted in the registry

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 8 to 14 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • age 8 to 14 years;
  • obesity defined as BMI z-score ≥+2 standard deviation scores (SDS) based on the WHO growth charts
  • gestational age 37-42 weeks;
  • birth weight >2500 g and <4000 g;
  • established condition of MUO, defined as follows:
  • for children ≤10 years according to the IDEFICS criteria [waist circumference (WC) ≥90th percentile and ≥1 of the followings triglycerides (TG) ≥90th percentile, HDL cholesterol (HDL) ≤10th percentile, systolic blood pressure (SBP) or diastolic blood pressure (DBP) ≥90th percentile, HOMA-insulin resistance ≥90th percentile or fasting glucose ≥90th percentile];
  • for children >10 years according to the IDF criteria [WC ≥ 90th percentile and ≥1 of the followings TG ≥ 150 mg/Dl, HDL ≤ 40 mg/dL, SBP ≥ 130 mmHg, DBP ≥ 85 mmHg and fasting blood glucose ≥ 100 mg/dl or known Type 2 Diabetes]

Who cannot join

  • diagnosis of secondary obesity;
  • treatment with pre/probiotics in the previous 3 months;
  • antibiotic treatment in the previous 3 months;
  • presence of chronic or acute intestinal disease in the previous 3 months

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Department of Pediatrics, Vittore Buzzi Children's Hospital

    Milan, 20154

Other trials in Italy

About this study

Childhood obesity is a growing public health concern and is associated with long-term health issues. Changing lifestyle habits, especially improving diet and maintaining these changes over time, can be challenging for children and families. For this reason, new treatment options are being explored, including ways to improve the gut microbiota, which can influence appetite and host metabolic health.

This study will investigate the impact of a medical device made of polysaccharide-based complex together with healthy lifestyle and dietary intervention, on gut microbiota composition and metabolic health in children and adolescents with metabolically unhealthy obesity. The study will last 8 months and will include 3 visits: at the start (T0), after 4 months (T1), and after 8 months (T2). From T0 to T1, participants will receive the polysaccharide-based complex along with Mediterranean-style dietary and behavioral intervention. From T1 to T2, only the dietary-lifestyle program will continue.

At each visit, researchers will collect blood samples, perform nutritional and body composition assessment, and collect stool samples to characterise the gut microbiota. The primary aim is to evaluate the effect on gut microbiota composition of a polysaccharide-based complex administration combined with dietary and lifestyle interventions. Furthermore, the study aims to evaluate the effectiveness of this intervention in improving obesity-related parameters and the overall cardiometabolic profile.

Being tested
Polysaccharide-based complex
Keywords
childhood obesity, gut microbiota, metabolic syndrome, mediterranean diet, fiber
Medical subject headings
Pediatric Obesity, Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Polysaccharide-based complexDevice

    Also called Neo-Policaptil Gel Retard

    The Polysaccharide-based complex is a medical device composed of mixture of soluble and insoluble fibres (cellulose, hemicellulose, pectin, mucilages). After enrolment at T0, participants were instructed to consume a polysaccharide-based complex for 4 months at a dosage of two sachets daily, to be consumed one before lunch and one before dinner (total 5 g/day).

Study groups in NCT07321184
Study groupRoleWhat they receive
Single-arm Pre-Post TreatmentExperimentalAt T0 (enrollment), participants will undergo baseline assessments. From T0 to T1, they will receive a polysaccharide-based complex together with a dietary and lifestyle intervention based on Mediterranean diet principles. From T1 to T2, the polysaccharide-based complex will be discontinued, and participants will continue only with the dietary and lifestyle intervention as a washout phase. Assessments at T0, T1, and T2 will be used to evaluate changes over time.
Receives: Device: Polysaccharide-based complex

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. gut microbiota composition

    Collection of fecal samples, bacterial DNA extraction and analysis of V3-V4 hypervariable regions of the prokaryotic 16S ribosomal RNA (rRNA) gene

    Measured: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)

Secondary outcomes (28)

  1. Body Weight

    Body weight Description: Body weight measured in kilograms using a calibrated scale. Unit of Measure: kg

    Measured: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)

  2. Height

    Height Description: Standing height measured using a stadiometer. Unit of Measure: cm

    Measured: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)

  3. Height z-score

    Height z-score Description: Height-for-age z-score calculated according to reference growth charts.

    Unit of Measure: z-score

    Measured: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)

  4. Body Mass Index

    Body Mass Index (BMI) Description: weight and height will be combined to report BMI in kg/m^2 Unit of measure: kg/m^2

    Measured: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)

  5. Body Mass Index z-score

    BMI z-score Description: BMI-for-age z-score calculated according to reference growth charts. Unit of Measure: z-score

    Measured: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)

  6. Waist circumference

    Waist circumference Description: : Waist circumference measured in centimeters using a non-elastic measuring tape. Unit of Measure: cm

    Measured: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)

  7. Waist-to-height ratio

    Waist-to-height ratio Description: : Waist-to-height ratio calculated as waist circumference divided by height. Unit of Measure: unitless ratio

    Measured: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)

  8. Fat mass (kg)

    Total body fat mass expressed in kilograms, assessed using air plethysmography. Unit of Measure: kg

    Measured: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)

  9. Fat mass (%)

    Percentage of total body fat relative to body weight, assessed using air plethysmography.

    Unit of Measure: %

    Measured: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)

  10. Fat free mass (kg)

    Total fat-free mass expressed in kilograms, assessed using air plethysmography. Unit of Measure: kg

    Measured: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)

  11. Fat free mass (%)

    Percentage of fat-free mass relative to body weight, assessed using air plethysmography.

    Unit of Measure: %

    Measured: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)

  12. Systolic blood pressure

    Systolic blood pressure measured in millimeters of mercury using a calibrated sphygmomanometer.

    Unit of Measure: mmHg

    Measured: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)

  13. Diastolic blood pressure

    Diastolic blood pressure measured in millimeters of mercury using a calibrated sphygmomanometer.

    Unit of Measure: mmHg

    Measured: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)

  14. Fasting glucose

    Fasting plasma glucose concentration measured in venous blood samples. Unit of Measure: mg/dL

    Measured: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)

  15. Fasting insulin

    Fasting plasma insulin concentration measured in venous blood samples. Unit of Measure: µU/mL

    Measured: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)

  16. Glycated hemoglobin (HbA1c)

    Glycated hemoglobin (HbA1c) concentration measured in whole blood as an indicator of long-term glycemic control.

    Unit of Measure: mmol/mol

    Measured: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)

  17. Lipid profile

    Fasting serum lipid concentrations including total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides. Each lipid parameter will be analyzed and reported separately.

    Unit of Measure: mg/dL

    Measured: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)

  18. Liver enzymes

    Serum liver enzyme concentrations including aspartate aminotransferase (AST) and alanine aminotransferase (ALT). Each enzyme will be analyzed and reported separately.

    Unit of Measure: U/L

    Measured: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)

  19. Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)

    Insulin resistance assessed using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), calculated from fasting plasma glucose and fasting plasma insulin concentrations.

    Unit of Measure: index value

    Measured: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)

  20. Quantitative Insulin Sensitivity Check Index (QUICKI)

    Insulin sensitivity assessed using the Quantitative Insulin Sensitivity Check Index (QUICKI), calculated from fasting plasma glucose and fasting plasma insulin concentrations.

    Unit of Measure: index value

    Measured: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)

  21. Triglyceride-Glucose (TyG) index

    Insulin resistance assessed using the Triglyceride-Glucose (TyG) index, calculated from fasting triglyceride and fasting plasma glucose concentrations.

    Unit of Measure: index value

    Measured: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)

  22. Atherogenic Index of Plasma (AIP)

    Atherogenic risk assessed using the Atherogenic Index of Plasma (AIP), calculated as the logarithm of the ratio between triglycerides and HDL cholesterol concentrations.

    Unit of Measure: index value

    Measured: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)

  23. Energy Intake

    Energy intake Unit: kcal/day

    Measured: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)

  24. Macronutrient intake (grams/day)

    Daily intake of macronutrients expressed in grams per day, including:

    • carbohydrates,
    • sugars,
    • total dietary fibers,
    • insoluble fibers,
    • soluble fibers,
    • proteins,
    • animal proteins,
    • plant proteins,
    • total lipids,
    • saturated fatty acids,
    • monounsaturated fatty acids,
    • polyunsaturated fatty acids, Each macronutrient will be analyzed and reported separately.

    Unit of Measure: g/day

    Measured: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)

  25. Macronutrient intake (% of energy)

    Contribution of macronutrients to total energy intake expressed as percentage of energy, including:

    • carbohydrates,
    • sugars,
    • proteins,
    • total lipids,
    • saturated fatty acids,
    • monounsaturated fatty acids,
    • polyunsaturated fatty acids,
    • omega-3 fatty acids,
    • omega-6 fatty acids. Each macronutrient will be analyzed and reported separately. Unit of Measure: % of daily energy intake (%En)

    Measured: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)

  26. Micronutrients (µg/day)

    Daily intake of vitamin B12 and folic acid expressed in micrograms per day. Unit of Measure: µg/day

    Measured: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)

  27. Micronutrients (mg/day)

    Daily intake of calcium, iron, zinc, and magnesium expressed in milligrams per day.

    Unit of Measure: mg/day

    Measured: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)

  28. KIDMED score

    Adherence to the Mediterranean diet assessed using the KIDMED questionnaire (score range 0-12).

    Unit of Measure: score

    Measured: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2026
  2. Study start1 Feb 2022
  3. Primary completion30 Nov 2023
  4. Study completion30 Nov 2024

Resources

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07321184
Sponsor's protocol ID
2021/ST/260
Other IDs
Ethical Committe
Acronym
Polymets
Status last verified
Dec 2025
First submitted
25 Nov 2025
Last updated
6 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No individual participant data will be shared because the study involves minors

Publications

  • Serra-Majem L, Ribas L, Ngo J, Ortega RM, Garcia A, Perez-Rodrigo C, Aranceta J. Food, youth and the Mediterranean diet in Spain. Development of KIDMED, Mediterranean Diet Quality Index in children and adolescents. Public Health Nutr. 2004 Oct;7(7):931-5. doi: 10.1079/phn2004556.

    PubMed 15482620

  • Altavilla C, Caballero-Perez P. An update of the KIDMED questionnaire, a Mediterranean Diet Quality Index in children and adolescents. Public Health Nutr. 2019 Oct;22(14):2543-2547. doi: 10.1017/S1368980019001058. Epub 2019 May 31.

    PubMed 31146796

  • Stagi S, Lapi E, Seminara S, Pelosi P, Del Greco P, Capirchio L, Strano M, Giglio S, Chiarelli F, de Martino M. Policaptil Gel Retard significantly reduces body mass index and hyperinsulinism and may decrease the risk of type 2 diabetes mellitus (T2DM) in obese children and adolescents with family history of obesity and T2DM. Ital J Pediatr. 2015 Feb 15;41:10. doi: 10.1186/s13052-015-0109-7.

    PubMed 25774705

  • Zimmet P, Alberti KG, Kaufman F, Tajima N, Silink M, Arslanian S, Wong G, Bennett P, Shaw J, Caprio S; IDF Consensus Group. The metabolic syndrome in children and adolescents - an IDF consensus report. Pediatr Diabetes. 2007 Oct;8(5):299-306. doi: 10.1111/j.1399-5448.2007.00271.x. No abstract available.

    PubMed 17850473

  • Ahrens W, Moreno LA, Marild S, Molnar D, Siani A, De Henauw S, Bohmann J, Gunther K, Hadjigeorgiou C, Iacoviello L, Lissner L, Veidebaum T, Pohlabeln H, Pigeot I; IDEFICS consortium. Metabolic syndrome in young children: definitions and results of the IDEFICS study. Int J Obes (Lond). 2014 Sep;38 Suppl 2:S4-14. doi: 10.1038/ijo.2014.130.

    PubMed 25376220

  • Damanhoury S, Newton AS, Rashid M, Hartling L, Byrne JLS, Ball GDC. Defining metabolically healthy obesity in children: a scoping review. Obes Rev. 2018 Nov;19(11):1476-1491. doi: 10.1111/obr.12721. Epub 2018 Aug 28.

    PubMed 30156016

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Polysaccharide-based complex in people with Childhood Obesity, run by University of Milan at 1 site in Italy.

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 7 inclusion and 4 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: finished, as of the sponsor's last update on 6 Jan 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 Italy. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

gut microbiota composition (time frame: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)). 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 NCT07321184, which also lists 6 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 6 Jan 2026.

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