Effects of VLCKD in Metabolic Syndrome

Obesity Clinical Trial

— KETO-MI  

Official title:

Effects of Very Low Calorie Ketogenic Diet on Microbiota, Adipose Tissue and Immunitary Regulation: Pilot Study on Patients With Metabolic Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05275608
• Other study ID #: CE 296/21
• Status: Recruiting
• Phase: N/A
• Start date: November 7, 2022
• Est. completion date: December 2024

Study information

• Verified date: September 2023
• Source: Azienda Ospedaliero Universitaria Maggiore della Carita
• Contact: Flavia Prdoam, Prof. MD
• Phone: +39 0321 660 693
• Email: flavia.prodam[@]med.uniupo.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age 25-65

• BMI 30-40 mg/m2

• NAFLD

• DM2 drug-treated (metformin, SGLT2 inhibitors, GLP-1 analogues, DPPIV inhibitors, basal insulin) and HbA1c > 7 and < 10 %.

Exclusion Criteria:

• Secondary obesity due to genetic or endocrinologic causes.

• renal disease with eGFR < 45 mL/min/1.73m2 or macroalbuminuria or calculosis

• insulin basal + bolus or HbA1c% >10.0%

• Other types of DM

• ipopituitarism or adrenal insufficiency

• antibiotics use less than 3 months before the first visit

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Fatty Liver
• Liver Diseases
• Metabolic Syndrome
• Non-alcoholic Fatty Liver Disease
• Obesity
• Syndrome

Intervention

Dietary Supplement:
• VLCKD diet with replacing meals
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.

Behavioral:
• Hypocaloric mediterranean Diet
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).

Locations

Country	Name	City	State
Italy	: Italy Pediatric Endocrine Service of AOU Maggiore della Carità of Novara; SCDU of Pediatrics, Department of Health Sciences, University of Eastern Piedmont	Novara

Sponsors (2)

Lead Sponsor	Collaborator
Azienda Ospedaliero Universitaria Maggiore della Carita	Laboratoire THERASCIENCE

Country where clinical trial is conducted

Italy, 

References & Publications (56)

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* Note: There are 56 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in weight	Variation of body weight assessed through body mass index change (BMI)(kg/m2)	Change from Baseline BMI at 15 days, 30 days, 60 days, 90 days
Primary	Change in body circumferences	Variation of body circumferences (waist, hips)	Change from Baseline circumferences at 15 days, 30 days, 60 days, 90 days
Primary	Change in metabolic control	Variation of blood glucose	Change from Baseline blood glucose at 15 days, 30 days, 60 days, 90 days
Primary	Change in metabolic control	Change of cardio-metabolic risk factors: lipid profile	Change from Baseline lipid profile at 15 days, 30 days, 60 days, 90 days
Secondary	Change in Metabolic control	Change of cardio-metabolic risk factors: insulin resistance (HOMA-IR)	Change from Baseline HOMA-IR at 15 days, 30 days, 60 days, 90 days
Secondary	Change in kidney profile	Variation of serum creatinin	Change from Baseline Serum Creatinin at 15 days, 30 days, 60 days, 90 days
Secondary	Change in liver profile	Variation of liver profile (AST, ALT, GGT, bilirubin)	Change from Baseline liver profile at 15 days, 30 days, 60 days, 90 days
Secondary	Change in uric acid	Variation of uric acid in blood	Change from Baseline uric acid at 15 days, 30 days, 60 days, 90 days
Secondary	Change in blood pressure	Variation of blood pressure (diastolic and sistolic)	Change from Baseline blood pressure at 15 days, 30 days, 60 days, 90 days
Secondary	Change in body composition	Change of body composition (fat mass %) (BIVA)	Change from Baseline fat mass% at 15 days, 30 days, 60 days, 90 days
Secondary	Change in body composition	Change of body composition (fat mass %) (DXA)	Change from Baseline fat mass% at 90 days
Secondary	Change in muscolar functionality	Changes observed from functional tests (handgrip strenght)	Change from Baseline scores at 30, 90 days
Secondary	Change in muscolar functionality	Changes observed from functional tests (short physical portable battery score)	Change from Baseline scores at 30, 90 days
Secondary	Change in muscolar functionality	Changes observed from functional tests (time up and go test)	Change from Baseline scores at 30, 90 days
Secondary	Change in hormones	Variation of hormones in blood (ghrelin, leptin, adiponectin)	Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days
Secondary	Change in hormones	Variation of hormones in blood (irisin)	Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days
Secondary	Change in hormones	Variation of hormones in blood (zonulin)	Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days
Secondary	Change in hormones	Variation of hormones in blood (asprosin)	Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days
Secondary	Change in hormones	Variation of hormones in blood (TSH)	Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days
Secondary	Change in hormones	Variation of hormones in blood (FT4)	Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days
Secondary	Change in hormones	Variation of hormones in blood (PTH)	Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days
Secondary	Change in hormones	Variation of hormones in blood (25OH vitamin D)	Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days
Secondary	Change in hormones	Variation of hormones in blood (PYY)	Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days
Secondary	Change in hormones	Variation of hormones in blood (IGF-1)	Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days
Secondary	Change in blood ketones	Variation of ketones in blood	Change from Baseline blood ketones at 15, 30 days, 60 days, 90 days
Secondary	Change in basal metabolic rate	Variation of basal metabolic rate through indirect calorimetry	Change from Baseline basal metabolic rate at 90 days
Secondary	Change in urine ketones	Variation of urine excretion in terms of ketones	Change from Baseline urine ketones at 15, 30 days, 60 days, 90 days
Secondary	Change in urine nitrogen excretion	Variation of urine excretion in terms of nitrogen	Change from Baseline urine nitrogen at 15, 30 days, 60 days, 90 days
Secondary	Change in omics profile	Variation of metabolomic profile of stools through liquid and gas chromatography	Change from Baseline omic profile of stools at 15, 30 days, 60 days, 90 days
Secondary	Change in omics profile	Variation of lipidomic profile of stools through liquid and gas chromatography	Change from Baseline omic profile of stools at 15, 30 days, 60 days, 90 days
Secondary	Change in omics profile	Variation of proteomic profile of stools through liquid and gas chromatography	Change from Baseline omic profile of stools at 15, 30 days, 60 days, 90 days
Secondary	Change in microbiota	Variation of prevalence of microbiota phyla through DNA sequencing of stools	Change from Baseline of prevalence of microbiota phyla at 15, 30 days, 60 days, 90 days
Secondary	Change in inflammatory status	Variation of inflammatory status in blood (C-reactive protein CRP)	Change from Baseline CRP and cytokines at 15, 30 days, 60 days, 90 days
Secondary	Change in inflammatory status	Variation of inflammatory status in blood (cytokines count)	Change from Baseline cytokines at 15, 30 days, 60 days, 90 days