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Completed

NCT Number: NCT07321184

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

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.

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Key information

Conditions

Childhood Obesity Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

8 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Pediatrics, Vittore Buzzi Children's Hospital

Milan, 20154, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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]

Exclusion criteria

  • 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

Treatment and study plan

Polysaccharide-based complex

Device

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).

Other names: Neo-Policaptil Gel Retard

Primary outcomes

  1. gut microbiota composition

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

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

Secondary outcomes

  1. Body Weight

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

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

  2. Height

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

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

  3. Height z-score

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

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

    Unit of Measure: z-score

  4. Body Mass Index

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

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

  5. Body Mass Index z-score

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

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

  6. Waist circumference

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

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

  7. Waist-to-height ratio

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

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

  8. Fat mass (kg)

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

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

  9. Fat mass (%)

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

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

    Unit of Measure: %

  10. Fat free mass (kg)

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

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

  11. Fat free mass (%)

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

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

    Unit of Measure: %

  12. Systolic blood pressure

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

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

    Unit of Measure: mmHg

  13. Diastolic blood pressure

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

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

    Unit of Measure: mmHg

  14. Fasting glucose

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

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

  15. Fasting insulin

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

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

  16. Glycated hemoglobin (HbA1c)

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

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

    Unit of Measure: mmol/mol

  17. Lipid profile

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

    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

  18. Liver enzymes

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

    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

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

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

    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

  20. Quantitative Insulin Sensitivity Check Index (QUICKI)

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

    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

  21. Triglyceride-Glucose (TyG) index

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

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

    Unit of Measure: index value

  22. Atherogenic Index of Plasma (AIP)

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

    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

  23. Energy Intake

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

    Energy intake Unit: kcal/day

  24. Macronutrient intake (grams/day)

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

    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

  25. Macronutrient intake (% of energy)

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

    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)

  26. Micronutrients (µg/day)

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

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

  27. Micronutrients (mg/day)

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

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

    Unit of Measure: mg/day

  28. KIDMED score

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

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

    Unit of Measure: score

Other outcomes

  1. Mid-upper arm circumference (MUAC)

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

    Mid-upper arm circumference (MUAC) Description: : Mid-upper arm circumference measured in centimeters using a non-elastic measuring tape. Unit of Measure: cm

  2. Mid-upper arm circumference (MUAC) z-score

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

    Mid-upper arm circumference (MUAC) z-score Description: Mid-upper arm circumference-for-age z-score calculated according to reference growth standards. Unit of Measure: z-score

  3. Triceps skinfold thickness

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

    Triceps skinfold thickness measured in millimeters using a calibrated skinfold caliper.. Unit of Measure: mm

  4. Triceps skinfold thickness z-score

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

    Triceps skinfold thickness-for-age z-score calculated according to reference growth standards. Unit of Measure: z-score

  5. Presence of MASLD

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

    Description: Presence of metabolic dysfunction-associated steatotic liver disease (MASLD) assessed by abdominal ultrasound.

    Measure Type: Dichotomous (Yes/No)

Sponsors and collaborators

Lead sponsor

University of Milan

Other

Collaborators

  • ASST Fatebenefratelli Sacco

Registry information

Acronym: Polymets

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Jan 6, 2026
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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