Effect of POSTbiotics Supplementation on Microbiome in OBese Children: the POST-OB Study

Summary

Participation Requirements

Description

25-30 Caucasian obese children will be enrolled at the Pediatric Department of San Paolo Hospital - University of Milan. Stool samples from all enrolled patients at the different time points (t0, before supplementation and diet-lifestyle intervention, t1, four months after supplementation and diet-l...

25-30 Caucasian obese children will be enrolled at the Pediatric Department of San Paolo Hospital - University of Milan. Stool samples from all enrolled patients at the different time points (t0, before supplementation and diet-lifestyle intervention, t1, four months after supplementation and diet-lifestyle intervention and t2 four months after the end of supplementation and after the alone diet-lifestyle intervention) will be collected and stored at -80°C until the following investigation: study of the microbiota biodiversity by high-throughput sequencing techniques (16S rRNA gene sequencing) in order to establish whether postbiotics could modulate the microbial composition in obese children; analysis of short chain fatty acids concentration by gas-chromatography (GC-FID) in order to monitor the effect of postbiotics intake modulating microbial metabolite production. The following tasks will be also performed at t0, t1 and t2: Clinical examination including: physical examination, Tanner score evaluation; Bristol Stool Chart Blood pressure will be checked in all children by using oscillometric devices validated in the pediatric age group. Anthropometry including body circumferences and skinfolds, calculation of BMI z scores and body composition. Body composition will be assessed using an air displacement plethysmography system (BOD POD COSMED-USA). Dietary assessment: Food intakes will be recorded by prospective 3-d weighed food records obtained with food scales. Parents will be advised on how to record all food and beverages consumed during 2 weekdays and 1 weekend day. Quantification and analysis of the energy intake and nutrient composition will be performed with an ad hoc PC software (MètaDieta®, Me.Te.Da S.r.l., San Benedetto del Tronto, Italy). Mediterranean Diet Quality Index (KIDMED) questionnaire for Mediterranean Diet assessment. The KIDMED index ranges from 0 to 12, and is based on a 16-question test that can be self-administered. The sums of the values from the administered test will be classified into three levels: 8 or more: optimal Mediterranean diet; 4-7: improvement needed to adjust intake to Mediterranean patterns. 3 or less: very low diet quality. Hematological and biochemical status including: Complete cell blood count; Metabolic and nutritional parameters according to local routines for childhood obesity (fasting glucose, fasting insulin, LDL, HDL, total cholesterol, triglycerides, Apolipoprotein A and Apolipoprotein B levels, transaminases and amma-glutamyl transferase). Oral Glucose Tolerance Test (OGTT) will be performed. The insulin sensitivity and insulin resistance was assessed by calculating HOMA index (Homeostasis Model Assessment) and QUICKI (Quantitative Insulin-Sensitivity Check Index), using the following formulas: HOMA: fasting plasma insulin in mU/l x FPG in mmol/l/22.5 QUICKI: 1/(log10 fasting plasma insulin in mU/l + log10 glucose in mg/dl) Inflammatory index (VES, high-sensitive CRP, including fecal calprotectin) Liver ultrasonography will be performed by a single evaluator. All participants will follow a behavior (promotion of physical activity) and dietary treatment according to Italian dietary guidelines for childhood obesity. Postbiotics will be given at the dose of 80 mg/day (2 ml per day SMART D3 MATRIX Smartfarma S.r.l. Via San Vittore 40 - 20123 MILAN; fermented fructooligosaccharides from Lactobacillus paracasei strain CNCM I-5220). 2 mk of product will give 1600 UI/die of VIT D3.

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