This arm will receive a supplementation with Zinc and Myo-inositol once a day.

This arm will receive a supplementation with a same product equal to the active product but without Zinc and Myo-inositol inside.

Obesity, Childhood

Insulin Resistance

Zinc Deficiency

Inositol

In this active Group there will be a supplementation with Zinc (5 mg), Myo-inositol (2000 mg) and GOS (Galacto-oligosaccharides) of Pisum sativum (1000 mg)

Zinc

In this placebo Group there will be a supplementation with a product placebo equal to the active product with GOS (Galacto-oligosaccharides) of Pisum sativum(1000 mg) but without Zinc and Myo-inositol.

Placebos

Myoinositol

AOU Maggiore della Carità - Clinica Pediatrica - Ambulatorio di Auxologia ed Endocrinologia Pediatrica

ZIMBA: Clinical Trial in Paediatric Obesity

Effects of a Supplementation With Zinc and Myo-inositol in Paediatric Obesity

Evaluate if after the treatment with Myoinositol and Zinc supplementation there is a variation of HOMA-IR index.
Evaluate if after the treatment with probiotic there is a variation of HOMA-IR index.

Evaluate if after the treatment with Myoinositol and Zinc supplementation there is a reduction of glucose values during the OGTT at time 0' e 120' after oral glucose tolerance test.

Evaluate any variation of serum lipids, leptin, adiponectin, GLP1 and insulin during OGTT.

Evaluate new cytokines and metabolites that regulates hormone metabolism.

Simonetta Bellone

Assoc. Professor

Azienda Ospedaliero Universitaria Maggiore della Carita

The study is a triple blind study in which the treatment or intervention is unknown to the research participant, the individuals who administer the treatment or intervention, and the researchers who assess the outcomes.

This arm will receive a supplementation of probiotic containing Bifidobacterium breve B632 and Bifidobacterium breve BR03, 15 gtt/die (3x108 CFU/die) once a day.

This arm will receive a supplementation with a same product equal to the active product but without bifidobacterium inside.

Bifidobacterium breve BR03 and Bifidobacterium breve B632

BIFI-OBESE: Clinical Trial in Paediatric Obesity

BIFI-OBESE: Effect of Probiotic Bifidobacterium Breve BR03 and Bifidobacterium Breve B632 in Paediatric Obesity

Evaluate if after the treatment with probiotic there is a reduction of glucose values during the OGTT at time 0' e 120' after oral glucose tolerance test.

Evaluate if after the treatment with probiotic there is a variation of HOMA-IR index.

Evaluate any variation of fecal microbiome

Evaluate any variation of short-chain fatty acids in fecal samples

Evaluate new citokines and metabolites that regulates hormone metabolism.

Flavia Prodam

Assoc. Professor in Clinical Nutrition

In the first part of the study (Study 1, V0-V1) patients will be randomized in a open-label, into two groups homogeneous for number and sex of the subjects. One group will receive a supplementation of probiotic containing Bifidobacterium breve B632 and Bifidobacterium breve BR03, 15 gtt/die (3x108 CFU/die) and one group will receive a placebo for a total of 2 months of treatment. For patients who wants to continue the study there will be a cross-over study (study 2, V2-V3) after one month of wash-out.

These subjects will receive a standard diet according to routine clinical practice + a 30 minutes Mediterranean-Style Diet educational training with explanation of Mediterranean pyramid + gamification to Mediterranean diet inside the Hospital and at home throughout "The Mediterranean Goose".

These subjects will receive Standard Diet according to routine care and practice. The standard diet will be distributed with 55-60% of carbohydrates (45-50% complex and no more than 10% refined and processed sugars), 25-30% lipids and 15% proteins, and will be performedin accordance with the calories of an isocaloric balanced diet calculated throughout the Italian LARN Guidelines for age and gender (Società Italiana di Nutrizione Umana, 2014), inspired to Mediterranean pyramid.

The intervention consists in a standard diet according to routine clinical practice + a 30 minutes Mediterranean-Style Diet educational training with explanation of Mediterranean pyramid + gamification to Mediterranean diet inside the Hospital and at home throughout "The Mediterranean Goose".

Mediterranean-Style Diet Educational Training

"Mediterranean diet and enhancement of traditional foodstuff - MedDiet"

Pediatric Endocrine Service of AOU Maggiore della Carità of Novara; SCDU of Pediatrics, Department of Health Sciences, University of Eastern Piedmont

GOOD-DAY Trial in Paediatric Obesity

GOOD-DAY: Efficacy of Gamification of an educatiOnal Training tO meDiterranean Diet on Weight and Metabolic Control in pAediatric obesitY: a Pilot Open-label Randomized Controlled Trial

Improvement of cardio-metabolic risk factors: insulin resistance (HOMA-IR)

Improvement of cardio-metabolic risk factors: lipid profile

Improvement of cardio-metabolic risk factors: arterial hypertension

Adherence to Mediterranean Diet, evaluating food and habits questionnaires

Dipeptidyl-peptidase-4

STEMI

No-reflow

Bleeding

Plasma Dipeptidyl-peptidase-4 Activities With No-reflow and Bleeding

TIMI flow grade of <3 with a myocardial blush grade of 0-1 was defined as angiographic no-reflow

the composite of death, nonfatal MI, or stroke

defined as acute heart failure, atrial fibrillation, chest pain or re-acute myocardial infarction, complete atrioventricular block, cerebrovascular disease, ventricular fibrillation or ventricular tachycardia

defined as absolute hemoglobin drop (baseline to nadir)≥4g/dl, intracranial hemorrhage, retroperitoneal hemorrhage, use of red blood cell transfusion in patients with a baseline hemoglobin ≥9.0 g/dl, and use of red blood cell transfusion among patients with a baseline hemoglobin <9.0 g/dl and a witnessed bleeding event

l alanine/nutukimas

ZIMBA: Clinical Trial in Paediatric Obesity

BIFI-OBESE: Clinical Trial in Paediatric Obesity

GOOD-DAY Trial in Paediatric Obesity

Plasma Dipeptidyl-peptidase-4 Activities With No-reflow and Bleeding

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