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Non Alcoholic Fatty Liver Disease / Obesity / Hypocaloric mediterranean Diet · Interventional Study
ClinicalTrials.gov · September 10, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registry record for an ongoing or recently completed pilot interventional study comparing very-low-carbohydrate ketogenic diet (VLCKD) to a hypocaloric Mediterranean diet in patients with concurrent type 2 diabetes, obesity, and non-alcoholic fatty liver disease. No results are posted to the registry, so efficacy, safety, or any clinical benefit cannot be assessed from this record alone.
Interventional, Randomized, Parallel, Open label, Treatment purpose. Diabetes Mellitus, Type 2, Non-alcoholic Fatty Liver Disease, Obesity, Metabolic Syndrome; age from 25 Years; to 65 Years. Intervention: VLCKD. Compared with: Hypocaloric Mediterranean Diet — Active Comparator. n = 40. 1 site: Italy.
This is a registry record for an ongoing or recently completed pilot interventional study comparing very-low-carbohydrate ketogenic diet (VLCKD) to a hypocaloric Mediterranean diet in patients with concurrent type 2 diabetes, obesity, and non-alcoholic fatty liver disease. No results are posted to the registry, so efficacy, safety, or any clinical benefit cannot be assessed from this record alone.
Results not yet posted to registry; no efficacy, safety, or outcome data available.
No clinical impact can be inferred from this registry record, as results have not been posted. Clinicians should await peer-reviewed publication of results before drawing conclusions about the comparative effectiveness of VLCKD versus Mediterranean diet in this population.
This is a clinical trial registry record with no reported results; enrollment is active but not recruiting, making this an ongoing or recently completed study with outcomes not yet posted to the registry.
As stated by the source record.
Quoted from the source exactly as published.
No clinical impact can be inferred from this registry record, as results have not been posted. Clinicians should await peer-reviewed publication of results before drawing conclusions about the comparative effectiveness of VLCKD versus Mediterranean diet in this population.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT05275608). This is a study registration, not published results. Lead sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 40 participants (ESTIMATED). Conditions: Diabetes Mellitus, Type 2, Non-alcoholic Fatty Liver Disease, Obesity, Metabolic Syndrome. Interventions: DIETARY_SUPPLEMENT: VLCKD diet with replacing meals; BEHAVIORAL: Hypocaloric mediterranean Diet. Primary outcome measures: Change in weight , Change from Baseline BMI at 15 days, 30 days, 60 days, 90 days; Change in body circumferences , Change from Baseline circumferences at 15 days, 30 days, 60 days, 90 days; Change in metabolic control , Change from Baseline blood glucose at 15 days, 30 days, 60 days, 90 days; Change in metabolic control , Change from Baseline lipid profile at 15 days, 30 days, 60 days, 90 days. 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).
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.