NCT05275608Active, not recruiting
Effects of VLCKD in Metabolic Syndrome
Effects of Very Low Calorie Ketogenic Diet on Microbiota, Adipose Tissue and Immunitary Regulation: Pilot Study on Patients With Metabolic Syndrome
Source: ClinicalTrials.gov · Last updated 10 Sept 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 21 Feb 2022
- Start date
- 7 Nov 2022
- Primary completion date
- 31 Jan 2026
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della Carita
- NCT number
- NCT05275608
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 7 Nov 2022 to the primary completion date, 31 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- antibiotics use less than 3 months before the first visit
Other illness
- ipopituitarism or adrenal insufficiency
Lab values
- renal disease with eGFR \< 45 mL/min/1.73m2 or macroalbuminuria or calculosis
- insulin basal + bolus or HbA1c% \>10.0%
Other
- Secondary obesity due to genetic or endocrinologic causes.
- Other types of DM
Who the study is looking for
- 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 %.
Age in the registry: 25 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| : Italy Pediatric Endocrine Service of AOU Maggiore della Carità of Novara; SCDU of Pediatrics, Department of Health Sciences, University of Eastern Piedmont Coordinator of this site? Confirm its status | Novara | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.