Effect of Polysaccharide-based Complex Administration on the Gut Microbiome and Cardio-Metabolic Profile in Children With Obesity and Metabolic Syndrome.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- gut microbiota composition
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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]
排除标准
- •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
结局指标
主要结局
gut microbiota composition
时间窗: 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
次要结局
- 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))
- Waist circumference(At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2))
- Waist-to-height ratio(At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2))
- Fat mass (kg)(At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2))
- Fat mass (%)(At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2))
- Fat free mass (kg)(At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2))
- Fat free mass (%)(At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2))
- Systolic blood pressure(At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2))
- Diastolic blood pressure(At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2))
- Fasting glucose(At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2))
- Fasting insulin(At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2))
- Glycated hemoglobin (HbA1c)(At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2))
- Lipid profile(At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2))
- Liver enzymes(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)(At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2))
- Quantitative Insulin Sensitivity Check Index (QUICKI)(At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2))
- Triglyceride-Glucose (TyG) index(At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2))
- Atherogenic Index of Plasma (AIP)(At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2))
- Energy Intake(At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2))
- Macronutrient intake (grams/day)(At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2))
- Macronutrient intake (% of energy)(At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2))
- Micronutrients (µg/day)(At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2))
- Micronutrients (mg/day)(At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2))
- KIDMED score(At enrollment (T0), after 4 months (T1), at the end of the study at 8 months (T2))
研究者
Elvira Verduci
Full Professor, Medical Doctor
University of Milan