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

University of Milan

Status and phase: Completed; Phase 4

Conditions: Childhood Obesity

Treatments: Device: Polysaccharide-based complex

Study type: Interventional

Funder types: Other

Identifiers

NCT07321184

2021/ST/260

Ethical Committe (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 8 to 14 years old

Volunteers: No Healthy Volunteers

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:

  1. 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];
  2. 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Single-arm Pre-Post Treatment

Experimental group

Description:

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.

Treatment:

Device: Polysaccharide-based complex