Effects of VLCKD in Metabolic Syndrome

NCT05275608 | Recruiting

• 1 other identifier: CE 296/21
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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

• Change in body circumferences

  Variation of body circumferences (waist, hips)

  Change from Baseline circumferences at 15 days, 30 days, 60 days, 90 days

• Change in metabolic control

  Variation of blood glucose

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

• 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 Outcomes (30)

• Change in Metabolic control

  Change from Baseline HOMA-IR at 15 days, 30 days, 60 days, 90 days

• Change in kidney profile

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

• Change in liver profile

  Change from Baseline liver profile at 15 days, 30 days, 60 days, 90 days

• Change in uric acid

  Change from Baseline uric acid at 15 days, 30 days, 60 days, 90 days

• Change in blood pressure

  Change from Baseline blood pressure at 15 days, 30 days, 60 days, 90 days

Study Arms (2)

VLCKD

EXPERIMENTAL

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 %.

Dietary Supplement: VLCKD diet with replacing meals

Hypocaloric Mediterranean Diet

ACTIVE COMPARATOR

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 %.

Behavioral: Hypocaloric mediterranean Diet

Interventions

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.

VLCKD

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).

Hypocaloric Mediterranean Diet

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 %.

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliero Universitaria Maggiore della Carita: lead
• Laboratoire THERASCIENCE: collaborator

Study Sites (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, 28100, Italy

RECRUITING

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MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism

Central Study Contacts

Flavia Prdoam, Prof. MD

CONTACT

+39 0321 660 693; flavia.prodam@med.uniupo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Prof. in Clinical Nutrition and MD

Study Record Dates

• First Submitted: February 21, 2022
• First Posted: March 11, 2022
• Study Start: November 7, 2022
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 28, 2024

Record last verified: 2024-10

Locations

IT (1)