Effects of VLCKD in Metabolic Syndrome

NCT ID: NCT05275608

Last Updated: 2024-10-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-07
• Study Completion Date: 2025-12-31

Brief 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).

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VLCKD

20 Patients recruited from our endocrinology department that will keep the same medical visits frequency and drugs and accept to be randomized to one of the two groups.

Inclusion criteria:

• Age 25-65
• BMI 30-40 mg/m2
• NAFLD
• DM2 drug-treated (metformin, SGLT2 inhibitors, GLP-1 analogues, DPPIV inhibitors, insulin) and HbA1c > 7 and < 10 %.

Group Type: EXPERIMENTAL

VLCKD diet with replacing meals

Intervention Type: 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

20 Patients recruited from our endocrinology department that will keep the same medical visits frequency and drugs and accept to be randomized to one of the two groups.

Inclusion criteria:

• Age 25-65
• BMI 30-40 mg/m2
• NAFLD
• DM2 drug-treated (metformin, SGLT2 inhibitors, GLP-1 analogues, DPPIV inhibitors, insulin) and HbA1c > 7 and < 10 %.

Group Type: ACTIVE_COMPARATOR

Hypocaloric mediterranean Diet

Intervention Type: 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).

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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).

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laboratoire THERASCIENCE

UNKNOWN

Sponsor Role: collaborator

Azienda Ospedaliero Universitaria Maggiore della Carita

OTHER

Sponsor Role: lead

Responsible Party

Flavia Prodam

Associated Prof. in Clinical Nutrition and MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

: 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

Site Status: RECRUITING

Countries

Italy

Central Contacts

Flavia Prdoam, Prof. MD

Role: CONTACT

flavia.prodam@med.uniupo.it

+39 0321 660 693

Facility Contacts

Flavia Prodam, Prof. MD

Role: primary

flavia.prodam@med.uniupo.it

+39 0321 660 693

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Other Identifiers

CE 296/21

Identifier Type: -

Identifier Source: org_study_id