VLCKD has showed to be an impactful diet on several metabolism aspects and has proven to be useful for preventing and treating diabetes mellitus type 2, overweight, chronic inflammation and fatty liver. For this reason, the aim of this pilot study is to examinate the potential effect of a VLCKD on a group of patients that contemporarily have DM2, obesity and Non alcholic fatty liver disease (NAFLD), comparing the results with an ipocaloric diet based on Mediterranean Principles and Italian LARN (SINU 2014). This study will consider several interrelated outcomes such as anthropometric data, hematochemical and hormonal parameters, questionnaires, stool microbiota and omics, blood microvescicles, urine tests, instrumental tests (DXA, BIVA, ecographies), biopses and functional tests. 40 subjects will be evaluated and divided in two groups of 20 (VLCKD) and 20 (MedDiet).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Patients will receive an accurate teaching + brochure on VLCKD diet from an expert dietician and freely receive the correct amount of supplements provided from Labotaoire Therascience (4 or 5 meals). The supplements contain (in total) between 600 and 800 kcal, mainly fats, 1,2/1,5 g/body weight of proteins, very low amount of charbohydrates (\<30/40g/die), 10-20g fibers, + minerals and vitamins covering the needings of patients. After 6-8 weeks, 1 meal will be replaced with a natural dish rich in proteins.
Patients will receive an accurate teaching + brochure on an hypocaloric Mediterranean style diet (LARN 2014) from an expert dietician. Patients will follow the istructions on grams and foods to eat. The calories will be around minus 400-500 kcal from energy requirement (measured by indirect calorimetry \* physical activity score).
: Italy Pediatric Endocrine Service of AOU Maggiore della Carità of Novara; SCDU of Pediatrics, Department of Health Sciences, University of Eastern Piedmont
Novara, Italy, Italy
RECRUITINGChange in weight
Variation of body weight assessed through body mass index change (BMI)(kg/m2)
Time frame: Change from Baseline BMI at 15 days, 30 days, 60 days, 90 days
Change in body circumferences
Variation of body circumferences (waist, hips)
Time frame: Change from Baseline circumferences at 15 days, 30 days, 60 days, 90 days
Change in metabolic control
Variation of blood glucose
Time frame: Change from Baseline blood glucose at 15 days, 30 days, 60 days, 90 days
Change in metabolic control
Change of cardio-metabolic risk factors: lipid profile
Time frame: Change from Baseline lipid profile at 15 days, 30 days, 60 days, 90 days
Change in Metabolic control
Change of cardio-metabolic risk factors: insulin resistance (HOMA-IR)
Time frame: Change from Baseline HOMA-IR at 15 days, 30 days, 60 days, 90 days
Change in kidney profile
Variation of serum creatinin
Time frame: Change from Baseline Serum Creatinin at 15 days, 30 days, 60 days, 90 days
Change in liver profile
Variation of liver profile (AST, ALT, GGT, bilirubin)
Time frame: Change from Baseline liver profile at 15 days, 30 days, 60 days, 90 days
Change in uric acid
Variation of uric acid in blood
Time frame: Change from Baseline uric acid at 15 days, 30 days, 60 days, 90 days
Change in blood pressure
Variation of blood pressure (diastolic and sistolic)
Time frame: Change from Baseline blood pressure at 15 days, 30 days, 60 days, 90 days
Change in body composition
Change of body composition (fat mass %) (BIVA)
Time frame: Change from Baseline fat mass% at 15 days, 30 days, 60 days, 90 days
Change in body composition
Change of body composition (fat mass %) (DXA)
Time frame: Change from Baseline fat mass% at 90 days
Change in muscolar functionality
Changes observed from functional tests (handgrip strenght)
Time frame: Change from Baseline scores at 30, 90 days
Change in muscolar functionality
Changes observed from functional tests (short physical portable battery score)
Time frame: Change from Baseline scores at 30, 90 days
Change in muscolar functionality
Changes observed from functional tests (time up and go test)
Time frame: Change from Baseline scores at 30, 90 days
Change in hormones
Variation of hormones in blood (ghrelin, leptin, adiponectin)
Time frame: Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days
Change in hormones
Variation of hormones in blood (irisin)
Time frame: Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days
Change in hormones
Variation of hormones in blood (zonulin)
Time frame: Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days
Change in hormones
Variation of hormones in blood (asprosin)
Time frame: Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days
Change in hormones
Variation of hormones in blood (TSH)
Time frame: Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days
Change in hormones
Variation of hormones in blood (FT4)
Time frame: Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days
Change in hormones
Variation of hormones in blood (PTH)
Time frame: Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days
Change in hormones
Variation of hormones in blood (25OH vitamin D)
Time frame: Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days
Change in hormones
Variation of hormones in blood (PYY)
Time frame: Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days
Change in hormones
Variation of hormones in blood (IGF-1)
Time frame: Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days
Change in blood ketones
Variation of ketones in blood
Time frame: Change from Baseline blood ketones at 15, 30 days, 60 days, 90 days
Change in basal metabolic rate
Variation of basal metabolic rate through indirect calorimetry
Time frame: Change from Baseline basal metabolic rate at 90 days
Change in urine ketones
Variation of urine excretion in terms of ketones
Time frame: Change from Baseline urine ketones at 15, 30 days, 60 days, 90 days
Change in urine nitrogen excretion
Variation of urine excretion in terms of nitrogen
Time frame: Change from Baseline urine nitrogen at 15, 30 days, 60 days, 90 days
Change in omics profile
Variation of metabolomic profile of stools through liquid and gas chromatography
Time frame: Change from Baseline omic profile of stools at 15, 30 days, 60 days, 90 days
Change in omics profile
Variation of lipidomic profile of stools through liquid and gas chromatography
Time frame: Change from Baseline omic profile of stools at 15, 30 days, 60 days, 90 days
Change in omics profile
Variation of proteomic profile of stools through liquid and gas chromatography
Time frame: Change from Baseline omic profile of stools at 15, 30 days, 60 days, 90 days
Change in microbiota
Variation of prevalence of microbiota phyla through DNA sequencing of stools
Time frame: Change from Baseline of prevalence of microbiota phyla at 15, 30 days, 60 days, 90 days
Change in inflammatory status
Variation of inflammatory status in blood (C-reactive protein CRP)
Time frame: Change from Baseline CRP and cytokines at 15, 30 days, 60 days, 90 days
Change in inflammatory status
Variation of inflammatory status in blood (cytokines count)
Time frame: Change from Baseline cytokines at 15, 30 days, 60 days, 90 days
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