Clinical trial

Effects of VLCKD in Metabolic Syndrome

Recruiting now · Not applicable · 1 countries · Registry ID NCT05275608

Recruiting nowNot applicableInterventional

What this study is about

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).

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age25 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionDiabetes Mellitus, Type 2, Non-alcoholic Fatty Liver Disease, Obesity, Metabolic Syndrome

Full registry criteria

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

Treatments and study arms

VLCKD diet with replacing meals

Dietary Supplement

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.

Hypocaloric mediterranean Diet

Behavioral

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).

Primary outcomes

Change in weightChange from Baseline BMI at 15 days, 30 days, 60 days, 90 days

Variation of body weight assessed through body mass index change (BMI)(kg/m2)

Change in body circumferencesChange from Baseline circumferences at 15 days, 30 days, 60 days, 90 days

Variation of body circumferences (waist, hips)

Change in metabolic controlChange from Baseline blood glucose at 15 days, 30 days, 60 days, 90 days

Variation of blood glucose

Change in metabolic controlChange from Baseline lipid profile at 15 days, 30 days, 60 days, 90 days

Change of cardio-metabolic risk factors: lipid profile

Study locations

1 locations were listed when this page was built. The first 40 are shown.

: 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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Flavia Prodam, Prof. MDContact

Email · Call +39 0321 660 693