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NCT Number: NCT05275608

Effects of VLCKD in Metabolic Syndrome

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).

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Key information

Conditions

Diabetes Mellitus, Type 2 Body Weight Diabetes Mellitus Digestive System Diseases Endocrine System Diseases Fatty Liver Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Liver Diseases Metabolic Diseases Metabolic Syndrome Non-Alcoholic Fatty Liver Disease Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

: 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

Location status: Recruiting

Location contact

Flavia Prodam, Prof. MD

CONTACT

[email protected]

+39 0321 660 693

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  1. Change in weight

    Time frame: Change 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)

  2. Change in body circumferences

    Time frame: Change from Baseline circumferences at 15 days, 30 days, 60 days, 90 days

    Variation of body circumferences (waist, hips)

  3. Change in metabolic control

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

    Variation of blood glucose

  4. Change in metabolic control

    Time frame: Change from Baseline lipid profile at 15 days, 30 days, 60 days, 90 days

    Change of cardio-metabolic risk factors: lipid profile

Secondary outcomes

  1. Change in Metabolic control

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

    Change of cardio-metabolic risk factors: insulin resistance (HOMA-IR)

  2. Change in kidney profile

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

    Variation of serum creatinin

  3. Change in liver profile

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

    Variation of liver profile (AST, ALT, GGT, bilirubin)

  4. Change in uric acid

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

    Variation of uric acid in blood

  5. Change in blood pressure

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

    Variation of blood pressure (diastolic and sistolic)

  6. Change in body composition

    Time frame: Change from Baseline fat mass% at 15 days, 30 days, 60 days, 90 days

    Change of body composition (fat mass %) (BIVA)

  7. Change in body composition

    Time frame: Change from Baseline fat mass% at 90 days

    Change of body composition (fat mass %) (DXA)

  8. Change in muscolar functionality

    Time frame: Change from Baseline scores at 30, 90 days

    Changes observed from functional tests (handgrip strenght)

  9. Change in muscolar functionality

    Time frame: Change from Baseline scores at 30, 90 days

    Changes observed from functional tests (short physical portable battery score)

  10. Change in muscolar functionality

    Time frame: Change from Baseline scores at 30, 90 days

    Changes observed from functional tests (time up and go test)

  11. Change in hormones

    Time frame: Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days

    Variation of hormones in blood (ghrelin, leptin, adiponectin)

  12. Change in hormones

    Time frame: Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days

    Variation of hormones in blood (irisin)

  13. Change in hormones

    Time frame: Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days

    Variation of hormones in blood (zonulin)

  14. Change in hormones

    Time frame: Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days

    Variation of hormones in blood (asprosin)

  15. Change in hormones

    Time frame: Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days

    Variation of hormones in blood (TSH)

  16. Change in hormones

    Time frame: Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days

    Variation of hormones in blood (FT4)

  17. Change in hormones

    Time frame: Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days

    Variation of hormones in blood (PTH)

  18. Change in hormones

    Time frame: Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days

    Variation of hormones in blood (25OH vitamin D)

  19. Change in hormones

    Time frame: Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days

    Variation of hormones in blood (PYY)

  20. Change in hormones

    Time frame: Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days

    Variation of hormones in blood (IGF-1)

  21. Change in blood ketones

    Time frame: Change from Baseline blood ketones at 15, 30 days, 60 days, 90 days

    Variation of ketones in blood

  22. Change in basal metabolic rate

    Time frame: Change from Baseline basal metabolic rate at 90 days

    Variation of basal metabolic rate through indirect calorimetry

  23. Change in urine ketones

    Time frame: Change from Baseline urine ketones at 15, 30 days, 60 days, 90 days

    Variation of urine excretion in terms of ketones

  24. Change in urine nitrogen excretion

    Time frame: Change from Baseline urine nitrogen at 15, 30 days, 60 days, 90 days

    Variation of urine excretion in terms of nitrogen

  25. Change in omics profile

    Time frame: Change from Baseline omic profile of stools at 15, 30 days, 60 days, 90 days

    Variation of metabolomic profile of stools through liquid and gas chromatography

  26. Change in omics profile

    Time frame: Change from Baseline omic profile of stools at 15, 30 days, 60 days, 90 days

    Variation of lipidomic profile of stools through liquid and gas chromatography

  27. Change in omics profile

    Time frame: Change from Baseline omic profile of stools at 15, 30 days, 60 days, 90 days

    Variation of proteomic profile of stools through liquid and gas chromatography

  28. Change in microbiota

    Time frame: Change from Baseline of prevalence of microbiota phyla at 15, 30 days, 60 days, 90 days

    Variation of prevalence of microbiota phyla through DNA sequencing of stools

  29. Change in inflammatory status

    Time frame: Change from Baseline CRP and cytokines at 15, 30 days, 60 days, 90 days

    Variation of inflammatory status in blood (C-reactive protein CRP)

  30. Change in inflammatory status

    Time frame: Change from Baseline cytokines at 15, 30 days, 60 days, 90 days

    Variation of inflammatory status in blood (cytokines count)

Study contacts

Contact information is provided by the study sponsor or research team.

Flavia Prdoam, Prof. MD

CONTACT

[email protected]

+39 0321 660 693

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero Universitaria Maggiore della Carita

Other

Collaborators

  • Laboratoire THERASCIENCE

Registry information

Official study title

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

Acronym: KETO-MI

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 11, 2022
Registry last updated
Oct 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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