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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
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).
Department of Pediatrics, Vittore Buzzi Children's Hospital
Milan, Italy
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
Time frame: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)
Body Weight
Body weight Description: Body weight measured in kilograms using a calibrated scale. Unit of Measure: kg
Time frame: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)
Height
Height Description: Standing height measured using a stadiometer. Unit of Measure: cm
Time frame: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)
Height z-score
Height z-score Description: Height-for-age z-score calculated according to reference growth charts. Unit of Measure: z-score
Time frame: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)
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
Time frame: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)
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
Time frame: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)
Waist circumference
Waist circumference Description: : Waist circumference measured in centimeters using a non-elastic measuring tape. Unit of Measure: cm
Time frame: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)
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
Time frame: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)
Fat mass (kg)
Total body fat mass expressed in kilograms, assessed using air plethysmography. Unit of Measure: kg
Time frame: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)
Fat mass (%)
Percentage of total body fat relative to body weight, assessed using air plethysmography. Unit of Measure: %
Time frame: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)
Fat free mass (kg)
Total fat-free mass expressed in kilograms, assessed using air plethysmography. Unit of Measure: kg
Time frame: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)
Fat free mass (%)
Percentage of fat-free mass relative to body weight, assessed using air plethysmography. Unit of Measure: %
Time frame: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)
Systolic blood pressure
Systolic blood pressure measured in millimeters of mercury using a calibrated sphygmomanometer. Unit of Measure: mmHg
Time frame: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)
Diastolic blood pressure
Diastolic blood pressure measured in millimeters of mercury using a calibrated sphygmomanometer. Unit of Measure: mmHg
Time frame: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)
Fasting glucose
Fasting plasma glucose concentration measured in venous blood samples. Unit of Measure: mg/dL
Time frame: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)
Fasting insulin
Fasting plasma insulin concentration measured in venous blood samples. Unit of Measure: µU/mL
Time frame: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)
Glycated hemoglobin (HbA1c)
Glycated hemoglobin (HbA1c) concentration measured in whole blood as an indicator of long-term glycemic control. Unit of Measure: mmol/mol
Time frame: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)
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
Time frame: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)
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
Time frame: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)
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
Time frame: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)
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
Time frame: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)
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
Time frame: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)
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
Time frame: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)
Energy Intake
Energy intake Unit: kcal/day
Time frame: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)
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
Time frame: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)
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)
Time frame: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)
Micronutrients (µg/day)
Daily intake of vitamin B12 and folic acid expressed in micrograms per day. Unit of Measure: µg/day
Time frame: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)
Micronutrients (mg/day)
Daily intake of calcium, iron, zinc, and magnesium expressed in milligrams per day. Unit of Measure: mg/day
Time frame: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)
KIDMED score
Adherence to the Mediterranean diet assessed using the KIDMED questionnaire (score range 0-12). Unit of Measure: score
Time frame: At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2)
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