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Effects of VLCKD in Metabolic Syndrome

ConditionsDiabetes Mellitus, Type 2Non-alcoholic Fatty Liver DiseaseObesityMetabolic Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-65
SponsorAzienda Ospedaliero Universitaria Maggiore della Carita

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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 %.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: VLCKDExperimental treatment 1 intervention
Group B: Hypocaloric Mediterranean DietActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change 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
2

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
3

Change in metabolic control

Variation of blood glucose

Time frame
Change from Baseline blood glucose at 15 days, 30 days, 60 days, 90 days
4

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

Secondary outcomes

1

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
2

Change in kidney profile

Variation of serum creatinin

Time frame
Change from Baseline Serum Creatinin at 15 days, 30 days, 60 days, 90 days
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Azienda Ospedaliero Universitaria Maggiore della Carita

Lead sponsor

Laboratoire THERASCIENCE

Collaborator

Source ClinicalTrials.gov
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