RecruitingNot ApplicableNCT05275608

Effects of VLCKD in Metabolic Syndrome

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

Sponsor

Azienda Ospedaliero Universitaria Maggiore della Carita

Enrollment

40 participants

Start Date

Nov 7, 2022

Study Type

INTERVENTIONAL

Conditions

Obesity Metabolic Syndrome Non-Alcoholic Fatty Liver Disease Diabetes Mellitus, Type 2

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).

Eligibility

Min Age: 25 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests a very low-carbohydrate ketogenic diet (VLCKD) in people who have both fatty liver disease (NAFLD) and type 2 diabetes with metabolic syndrome, to see if it improves metabolic health. **You may be eligible if...** - You are 25–65 years old with a BMI of 30–40 - You have been diagnosed with fatty liver disease (NAFLD) - You have type 2 diabetes being managed with metformin, SGLT2 inhibitors, GLP-1 analogs, DPP4 inhibitors, or basal insulin - Your HbA1c (blood sugar marker) is between 7% and 10% **You may NOT be eligible if...** - Your obesity is caused by a genetic or hormonal condition - You have kidney disease (eGFR below 45 or significant protein in urine) - You use a full insulin regimen (basal + mealtime insulin) or your HbA1c is above 10% - You have pituitary or adrenal insufficiency - You have used antibiotics in the 3 months before enrollment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTVLCKD 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.

BEHAVIORALHypocaloric 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(1)

: 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

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NCT05275608

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