Evaluation of the possible effect of DHA supplementation, combined with interventions aimed at improving diet and lifestyle, on gut microbiota composition and metabolite production.
Differences in gut microbiota composition and function will be evaluated in obese children before starting the DHA supplementation and dietary-lifestyle intervention, at the end of DHA supplementation (4 months) e after 4 months of dietary dietary-lifestyle intervention without DHA supplementation. The investigators will identify the role of DHA on the intestinal microbiota and indicative species related to insulin resistance (IR). The investigators will determine whether DHA supplementation, combined with interventions to improve diet and lifestyle, reduces adverse metabolic consequences together with their co-morbidities. 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 for detection of fatty liver disease
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Docosahexaenoic Acid (DHA) will be given at the dose of 500 mg/day (2 ml per day DHA RICH OIL 25% aroma mandorla FoodAR Limbiate, Italy;50% DHA oil obtained from Schyzochitrium sp ; Martek Biosciences Corporation, Columbia, Maryland, USA) to all participants of the study. DHA 2 ml will provide about 16 kcal of energy.
All participants will underwent a visit at t0, t1 and t2 in which physical activity will be promoted according to Italian dietary guidelines for childhood obesity.
All participants will underwent a visit at t0, t1 and t2 in which healthy food habits will be promoted according to Italian dietary guidelines for childhood obesity.
Ospedale San Paolo
Milan, Italy
RECRUITINGChanges in gut microbiota composition.
Interventions aimed at improving diet and lifestyle, on gut microbiota composition and metabolite production. Differences in gut microbiota composition and function will be evaluated in obese children's stools before starting the DHA supplementation (t0) and dietary-lifestyle intervention, at the end of DHA supplementation (t1: +4 months) and after 4 months of dietary dietary-lifestyle intervention without DHA supplementation (t2: +8 months). Study of the microbiota biodiversity will be performed by high-throughput sequencing techniques (16S rRNA gene sequencing) in order to establish whether postbiotics could modulate the microbial composition in obese children
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in short-chain fatty acid production by gut microbiota
Interventions aimed at improving diet and lifestyle, on gut microbiota composition and metabolite production. Differences in gut microbiota composition and function will be evaluated in obese children's stools before starting the DHA supplementation (t0) and dietary-lifestyle intervention, at the end of DHA supplementation (t1: +4 months) and after 4 months of dietary dietary-lifestyle intervention without DHA supplementation (t2: +8 months). Analysis of short chain fatty acids concentration by gas-chromatography (GC-FID) will be performed in order to monitor the effect of postbiotics intake modulating microbial metabolite production
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in total cholesterol levels
Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile before starting the DHA supplementation (t0) and dietary-lifestyle intervention, at the end of DHA supplementation (t1: +4 months) and after 4 months of dietary dietary-lifestyle intervention without DHA supplementation (t2: +8 months).
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in LDL cholesterol levels
Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile before starting the DHA supplementation (t0) and dietary-lifestyle intervention, at the end of DHA supplementation (t1: +4 months) and after 4 months of dietary dietary-lifestyle intervention without DHA supplementation (t2: +8 months).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in HDL cholesterol levels
Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile before starting the DHA supplementation (t0) and dietary-lifestyle intervention, at the end of DHA supplementation (t1: +4 months) and after 4 months of dietary dietary-lifestyle intervention without DHA supplementation (t2: +8 months).
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in triglycerides levels
Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile before starting the DHA supplementation (t0) and dietary-lifestyle intervention, at the end of DHA supplementation (t1: +4 months) and after 4 months of dietary dietary-lifestyle intervention without DHA supplementation (t2: +8 months).
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in fasting glucose levels
Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile before starting the DHA supplementation (t0) and dietary-lifestyle intervention, at the end of DHA supplementation (t1: +4 months) and after 4 months of dietary dietary-lifestyle intervention without DHA supplementation (t2: +8 months).
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in fasting insulin levels
Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile before starting the DHA supplementation (t0) and dietary-lifestyle intervention, at the end of DHA supplementation (t1: +4 months) and after 4 months of dietary dietary-lifestyle intervention without DHA supplementation (t2: +8 months).
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in HOMA index (Homeostasis Model Assessment)
Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile before starting the DHA supplementation (t0) and dietary-lifestyle intervention, at the end of DHA supplementation (t1: +4 months) and after 4 months of dietary dietary-lifestyle intervention without DHA supplementation (t2: +8 months).
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in QUICKI (Quantitative Insulin-Sensitivity Check Index)
Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile before starting the DHA supplementation (t0) and dietary-lifestyle intervention, at the end of DHA supplementation (t1: +4 months) and after 4 months of dietary dietary-lifestyle intervention without DHA supplementation (t2: +8 months).
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in alanine aminotransferase (ALT) levels
Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile before starting the DHA supplementation (t0) and dietary-lifestyle intervention, at the end of DHA supplementation (t1: +4 months) and after 4 months of dietary dietary-lifestyle intervention without DHA supplementation (t2: +8 months).
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in aspartate aminotransferase (ALT) levels
Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile before starting the DHA supplementation (t0) and dietary-lifestyle intervention, at the end of DHA supplementation (t1: +4 months) and after 4 months of dietary dietary-lifestyle intervention without DHA supplementation (t2: +8 months).
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in gamma glutamyl transferase (GGT) levels
Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile before starting the DHA supplementation (t0) and dietary-lifestyle intervention, at the end of DHA supplementation (t1: +4 months) and after 4 months of dietary dietary-lifestyle intervention without DHA supplementation (t2: +8 months).
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in body mass index
Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile before starting the DHA supplementation (t0) and dietary-lifestyle intervention, at the end of DHA supplementation (t1: +4 months) and after 4 months of dietary dietary-lifestyle intervention without DHA supplementation (t2: +8 months).
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in waist circumference
Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile before starting the DHA supplementation (t0) and dietary-lifestyle intervention, at the end of DHA supplementation (t1: +4 months) and after 4 months of dietary dietary-lifestyle intervention without DHA supplementation (t2: +8 months).
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in triceps skinfold
Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile before starting the DHA supplementation (t0) and dietary-lifestyle intervention, at the end of DHA supplementation (t1: +4 months) and after 4 months of dietary dietary-lifestyle intervention without DHA supplementation (t2: +8 months).
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in systemic arterial blood pressure
Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile before starting the DHA supplementation (t0) and dietary-lifestyle intervention, at the end of DHA supplementation (t1: +4 months) and after 4 months of dietary dietary-lifestyle intervention without DHA supplementation (t2: +8 months).
Time frame: t0: 0 t1: +4 months t2: +8 months
Complete cell blood count
Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile before starting the DHA supplementation (t0) and dietary-lifestyle intervention, at the end of DHA supplementation (t1: +4 months) and after 4 months of dietary dietary-lifestyle intervention without DHA supplementation (t2: +8 months).
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in C-reactive protein (CRP) levels
Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile before starting the DHA supplementation (t0) and dietary-lifestyle intervention, at the end of DHA supplementation (t1: +4 months) and after 4 months of dietary dietary-lifestyle intervention without DHA supplementation (t2: +8 months).
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in erythrocyte sedimentation rate (ESR)
Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile before starting the DHA supplementation (t0) and dietary-lifestyle intervention, at the end of DHA supplementation (t1: +4 months) and after 4 months of dietary dietary-lifestyle intervention without DHA supplementation (t2: +8 months).
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in fecal calprotectin levels
Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile before starting the DHA supplementation (t0) and dietary-lifestyle intervention, at the end of DHA supplementation (t1: +4 months) and after 4 months of dietary dietary-lifestyle intervention without DHA supplementation (t2: +8 months).
Time frame: t0: 0 t1: +4 months t2: +8 months
Changes in body mass composition
Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile before starting the DHA supplementation (t0) and dietary-lifestyle intervention, at the end of DHA supplementation (t1: +4 months) and after 4 months of dietary dietary-lifestyle intervention without DHA supplementation (t2: +8 months). body mass composition will be assessed using an air displacement plethysmography system (BOD POD COSMED-USA)
Time frame: t0: 0 t1: +4 months t2: +8 months
Oral glucose tolerance test (OGTT) result
Fasting glucose and glucose levels after 2 hours from ingestion of a glucose-containing solution.
Time frame: t0
Degree of fatty liver disease evaluated by echosonography of the liver
Interventions aimed at improving diet and lifestyle, on anthropometrics data and glucose and lipid profile before starting the DHA supplementation (t0) and dietary-lifestyle intervention, at the end of DHA supplementation (t1: +4 months) and after 4 months of dietary dietary-lifestyle intervention without DHA supplementation (t2: +8 months). body mass composition will be assessed using an air displacement plethysmography system (BOD POD COSMED-USA)
Time frame: t0: 0 t1: +4 months t2: +8 months