NCT07321184

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: University of Milan · Academic / Other
• Sex: All
• Age: 8 Years – 14 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Polysaccharide-based complex	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).

Timeline

• Start date: 2022-02-01
• Primary completion: 2023-11-30
• Completion: 2024-11-30
• First posted: 2026-01-06
• Last updated: 2026-01-06

Locations

1 site across 1 country: Italy