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

NCT07321184 | Completed Phase 4

• 2 other identifiers: 2021/ST/260Ethical Committe
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Childhood Obesity

Keywords

childhood obesity; gut microbiota; metabolic syndrome; mediterranean diet; fiber

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (28)

• Body Weight

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

• Height

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

• Height z-score

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

• Body Mass Index

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

• Body Mass Index z-score

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

Other Outcomes (5)

• Mid-upper arm circumference (MUAC)

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

• Mid-upper arm circumference (MUAC) z-score

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

• Triceps skinfold thickness

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

Study Arms (1)

Single-arm Pre-Post Treatment

EXPERIMENTAL

At 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.

Device: Polysaccharide-based complex

Interventions

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).

Also known as: Neo-Policaptil Gel Retard

Single-arm Pre-Post Treatment

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 \[WC ≥ 90th percentile and ≥1 of the followings TG ≥ 150 mg/Dl, HDL ≤ 40 mg/dL, SBP ≥ 130 mmHg, DBP ≥ 85 mmHg and fasting blood glucose ≥ 100 mg/dl or known Type 2 Diabetes\]

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Milan: lead
• ASST Fatebenefratelli Sacco: collaborator

Study Sites (1)

Department of Pediatrics, Vittore Buzzi Children's Hospital

Milan, 20154, Italy

Location

Related Publications (6)

• 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.

  PMID: 15482620 RESULT

• 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.

  PMID: 31146796 RESULT

• 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.

  PMID: 25774705 RESULT

• 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.

  PMID: 17850473 RESULT

• 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.

  PMID: 25376220 RESULT

• 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.

  PMID: 30156016 RESULT

MeSH Terms

Conditions

Pediatric Obesity; Metabolic Syndrome

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor, Medical Doctor

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: January 6, 2026
• Study Start: February 1, 2022
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2024
• Last Updated: January 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)