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Recruiting NCT05275608

Effects of VLCKD in Metabolic Syndrome

No phase Interventional Diabetes Mellitus, Type 2 Non-alcoholic Fatty Liver Disease Obesity Metabolic Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: VLCKD diet with replacing meals, Hypocaloric mediterranean Diet.
Who it may be relevant to
Registry conditions: Diabetes Mellitus, Type 2, Non-alcoholic Fatty Liver Disease, Obesity, Metabolic Syndrome. Basic parameters: 25 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

  • Dietary supplement 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 i
  • Behavioral 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).

Primary outcome measures

  • Change in weight [Time frame: Change from Baseline BMI at 15 days, 30 days, 60 days, 90 days]
  • Change in body circumferences [Time frame: Change from Baseline circumferences at 15 days, 30 days, 60 days, 90 days]
  • Change in metabolic control [Time frame: Change from Baseline blood glucose at 15 days, 30 days, 60 days, 90 days]
  • Change in metabolic control [Time frame: Change from Baseline lipid profile at 15 days, 30 days, 60 days, 90 days]
Secondary outcome measures (12)
  • Change in Metabolic control [Time frame: Change from Baseline HOMA-IR at 15 days, 30 days, 60 days, 90 days]
  • Change in kidney profile [Time frame: Change from Baseline Serum Creatinin at 15 days, 30 days, 60 days, 90 days]
  • Change in liver profile [Time frame: Change from Baseline liver profile at 15 days, 30 days, 60 days, 90 days]
  • Change in uric acid [Time frame: Change from Baseline uric acid at 15 days, 30 days, 60 days, 90 days]
  • Change in blood pressure [Time frame: Change from Baseline blood pressure at 15 days, 30 days, 60 days, 90 days]
  • Change in body composition [Time frame: Change from Baseline fat mass% at 15 days, 30 days, 60 days, 90 days]
  • Change in body composition [Time frame: Change from Baseline fat mass% at 90 days]
  • Change in muscolar functionality [Time frame: Change from Baseline scores at 30, 90 days]
  • Change in muscolar functionality [Time frame: Change from Baseline scores at 30, 90 days]
  • Change in muscolar functionality [Time frame: Change from Baseline scores at 30, 90 days]
  • Change in hormones [Time frame: Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days]
  • Change in hormones [Time frame: Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Italy · 1 center
  • : Italy Pediatric Endocrine Service of AOU Maggiore della Carità of Novara; SCDU of Pediat — Novara

Publications

  • Abbasi J. Interest in the Ketogenic Diet Grows for Weight Loss and Type 2 Diabetes. JAMA. 2018 Jan 16;319(3):215-217. doi: 10.1001/jama.2017.20639. No abstract available. PMID 29340675
  • American Diabetes Association. 5. Lifestyle Management: Standards of Medical Care in Diabetes-2019. Diabetes Care. 2019 Jan;42(Suppl 1):S46-S60. doi: 10.2337/dc19-S005. PMID 30559231
  • American Diabetes Association. 8. Obesity Management for the Treatment of Type 2 Diabetes: Standards of Medical Care in Diabetes-2019. Diabetes Care. 2019 Jan;42(Suppl 1):S81-S89. doi: 10.2337/dc19-S008. PMID 30559234
  • Ang QY, Alexander M, Newman JC, Tian Y, Cai J, Upadhyay V, Turnbaugh JA, Verdin E, Hall KD, Leibel RL, Ravussin E, Rosenbaum M, Patterson AD, Turnbaugh PJ. Ketogenic Diets Alter the Gut Microbiome Resulting in Decreased Intestinal Th17 Cells. Cell. 2020 Jun 11;181(6):1263-1275.e16. doi: 10.1016/j.cell.2020.04.027. Epub 2020 May 20. PMID 32437658
  • Very low-calorie diets. National Task Force on the Prevention and Treatment of Obesity, National Institutes of Health. JAMA. 1993 Aug 25;270(8):967-74. PMID 8345648
  • ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available. PMID 12091180
  • Baker ST, Jerums G, Prendergast LA, Panagiotopoulos S, Strauss BJ, Proietto J. Less fat reduction per unit weight loss in type 2 diabetic compared with nondiabetic obese individuals completing a very-low-calorie diet program. Metabolism. 2012 Jun;61(6):873-82. doi: 10.1016/j.metabol.2011.10.017. Epub 2011 Dec 5. PMID 22146094
  • Barengolts E. GUT MICROBIOTA, PREBIOTICS, PROBIOTICS, AND SYNBIOTICS IN MANAGEMENT OF OBESITY AND PREDIABETES: REVIEW OF RANDOMIZED CONTROLLED TRIALS. Endocr Pract. 2016 Oct;22(10):1224-1234. doi: 10.4158/EP151157.RA. Epub 2016 Jul 13. PMID 27409822

Identifiers

NCT: NCT05275608 · CE 296/21

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗