NASHKETONASHNCT06308757
Role of the Very Low Calorie Ketogenic Diet (VLCKD) in Patients With Non-Alcoholic Steatohepatitis (NASH) With Fibrosis
A study testing Very-low-calorie ketogenic diet (VLCKD) with meal replacements and Mediterranean low-calorie diet (LCD) in people with NASH and NAFLD, run by University of Bologna at 1 site in Italy.
Trial summary
The purpose of the KETONASH study is to evaluate, in patients with metabolic-associated fatty liver disease (MAFLD) with non-alcoholic steatohepatitis (NASH) and significant liver fibrosis, the effect of a very low-calorie ketogenic diet (VLCKD) compared to that of a standard low-calorie diet (standard Mediterranean… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Very-low-calorie ketogenic diet (VLCKD) with meal replacements and Mediterranean low-calorie diet (LCD)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteItaly
- Study dates
- 29 Sep 2021to 12 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged ≥18 years with histological diagnosis of NASH with evidence of fibrosis (defined according to NASH CRN) obtained no more than 6 months before enrollment;
- Stable weight for more than 6 months with BMI between 30-40 kg/m2;
- Patients in whom it is safe and feasible to proceed with liver biopsy and who consent to undergo liver biopsy after 12 months of enrollment to assess the effect of dietary treatment;
- Obtained informed consent.
Who cannot join
- BMI <30 or BMI >40
- Presence of evolved chronic liver disease into cirrhosis (histological F4 or elastometric LSM >14 kPa)
- Type 1 diabetes mellitus
- Model for End-stage Liver Disease (MELD) score >12, AST or ALT ≥5× ULN, HbA1c >9.5%, INR ≥1.4, creatinine >1.5 mg/dl, platelets <100,000/mm3, and total bilirubin >1.5 mg/dl.
- Concurrent presence of any other known chronic liver disease beyond MAFLD/NAFLD, such as alcoholic liver disease, viral (HCV/HBV), cholestatic-autoimmune (PBC/PSC/AIH), Wilson's disease, hemochromatosis, drug-induced liver injury (DILI), or the presence or suspicion of hepatocellular carcinoma (HCC);
- Average alcohol consumption exceeding 4/2 units/day (males/females) in the preceding 6 months and a history of excessive alcohol consumption in the last 5 years;
Show all 12Show fewer
- Previous or planned liver transplant, bariatric surgery, ileal resection, or biliary diversion;
- History of acute cholecystitis and biliary obstructions (cholangitis);
- Recent (in the last 12 months) or concurrent use of agents known to cause hepatic steatosis (long-term systemic corticosteroids [>10 days], amiodarone, methotrexate, tamoxifen, tetracyclines, high-dose estrogens, valproic acid);
- Recent (in the last 3 months) change in the dose/regimen or introduction of Vitamin E (at doses ≥400 IU/day), ursodeoxycholic acid (UDCA), betaine, S-adenosyl methionine, silymarin, or pentoxifylline;
- Presence of psychiatric disorders and/or diagnosis of any eating disorder;
- Life expectancy <6 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138
Federico Ravaioli, +393333176759, f.ravaioli@unibo.it
Sofia Penazza, 0512142477, sofia.penazza2@unibo.it
About this study
Official title: The Role of Very Low Calorie Ketogenic Diet (VLCKD) in Patients Affected by Non-Alcoholic Steatohepatitis (NASH) With Significant Fibrosis (KETONASH)
The purpose of the KETONASH study is to evaluate, in patients with metabolic-associated fatty liver disease (MAFLD) with non-alcoholic steatohepatitis (NASH) and significant liver fibrosis, the effect of a very low-calorie ketogenic diet (VLCKD) compared to that of a standard low-calorie diet (standard Mediterranean LCD - in accordance with the European Association for the Study of the Liver/European Society for Clinical Nutrition and Metabolism guidelines on MAFLD/NAFLD).
Read the detailed description
The KETONASH study is a multicenter, open-label, randomised, controlled clinical trial that will be consecutively proposed to all patients with histological diagnosis of non-alcoholic steatohepatitis (NASH) and significant hepatic fibrosis in the context of chronic metabolic liver disease (MAFLD/NAFLD).
Once the inclusion criteria are confirmed and the exclusion criteria are ruled out, patients will be subsequently randomly assigned (randomisation) with a 2:1 ratio to one of the two study arms:
- VLCKD Study Arm → will receive experimental diet therapy with very low-calorie ketogenic meals (VLCKD) consisting of 5 successive phases (600 - 1500 kcal/day).
- LCD Control Arm → will receive standard low-calorie diet therapy, a Mediterranean-type diet in accordance with the most recent guidelines on MAFLD/NAFLD (1200-1500 kcal/day).
The KETONASH study consists of an initial 4-month diet intervention phase (Visits 1-8), followed by a second 8-month weight maintenance phase (Visits 9-15). In both study arms, the intervention will be conducted through a standardised multidisciplinary approach (Physician/Dietitian/Nurse/Psychologist) aimed at weight loss through changes in dietary regimen, exercise program, and emotional support techniques.
The two study arms differ in nutritional composition, types of foods, and caloric intake.
- Conditions
- NASH, NAFLD, Obesity, Liver Fibrosis
- Being tested
- Very-low-calorie ketogenic diet (VLCKD) with meal replacements, Mediterranean low-calorie diet (LCD)
- Keywords
- vlckd, diet, ketogenic diet
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Obesity, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Very-low-calorie ketogenic diet (VLCKD) with meal replacementsDietary supplement
The VLCKD study arm will receive an experimental diet therapy with very-low-calorie ketogenic meal replacements (VLCKD) consisting of 5 successive phases (600 - 1500 kcal/day).
Mediterranean low-calorie diet (LCD)Dietary supplement
The Control arm LCD will receive standard Mediterranean type low-calorie diet (LCD) therapy by the most recent guidelines on MAFLD/NAFLD (1200-1500 kcal/day).
| Study group | Role | What they receive |
|---|---|---|
| VLCKD arm | Experimental | The VLCKD dietary intervention consists of five phases:
Ketogenic Low-Calorie Period (2 months):
* Phase 1 (30 days - Visits 1-3): Ketogenic diet with low-fat content, 600 kcal/day.
* Phase 2 (15 days - Visit 5): 660 kcal/day.
* Phase 3 (15 days - Visit 5): 730 kcal/day
Low-Calorie Period (2 months):
Phase 4 (30 days - Visits 6-7): Hypocaloric diet with the reintroduction of different foods, 1,050 kcal/day.
- Phase 5 (30 days - Visits 7-8): 1,400 kcal/day.
During these phases, the patient will receive nutritional supplementation with vitamins, trace elements, and omega-3 fatty acids. Throughout the very low-calorie ketogenic period, the patient will have three interim dietetic consultations (Visits 2-4) and a medical visit (Visit 5). During the low-calorie period, the patient will receive alternating two dietetic consultations (Visits 6 and 7) and one medical visit every 30 days (Visit 8). Receives: Dietary Supplement: Very-low-calorie ketogenic diet (VLCKD) with meal replacements |
| Control LCD arm | Active comparator | The control LCD arm consists of a diet with natural low-calorie foods (1200-1500 kcal/day or a reduction of 500-1000 kcal/day compared to baseline) and a low glycemic index based on the "Mediterranean Diet" model, following the most recent guidelines on MAFLD/NAFLD. Similar to the VLCKD arm, for the entire duration of the dietetic treatment, the patient will alternately receive dietetic consultations and medical visits.
At the end of the dietary intervention, patients from both study arms will continue with a controlled, low glycemic index diet tailored to the patient's basal metabolic rate (BMR) (estimated with bioimpedance assessment) for an additional six months.
Both study arms will follow a physical activity schedule and will have psychological-motivational support. Receives: Dietary Supplement: Mediterranean low-calorie diet (LCD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of at least one grade of liver fibrosis
Histological change of liver fibrosis without worsening of NASH
Measured: 12 months
Change of histological features of NASH
NASH parameters variation. Improvement in disease activity is defined as decrease in NAFLD Activity Score (NAS) ≥1 points. The worsening of fibrosis is defined as any numerical increase in the stage.
Measured: 12 months
Secondary outcomes (29)
Histological NIH NASH CRN Score
Assessment of individual histological components that make up the NIH NASH CRN (NASH Clinical Research Network) Score. NAS (NAFLD Activity Score) is the unweighted sum of steatosis, lobular inflammation, and hepatocellular ballooning scores. NAS of ≥5 correlated with a diagnosis of NASH, and biopsies with scores of less than 3 were diagnosed as not NASH.
Measured: 12 months
Histological FLIP/SAF changes
Assessment of individual histological components that make up the FLIP (fatty liver inhibition of progression) SAF (steatosis activity fibrosis) score (based on steatosis, ballooning, lobular inflammation, fibrosis, etc.). The score ranges from 0 (not NAFLD) to 3 (NASH).
Measured: 12 months
Biochemical test changes 1
Evaluation of variation of the biochemical tests panel based on normal ranges provided by the local laboratory. Multiple parameters are included in biochemical panel: aspartate transaminase (AST). Normal range: <50 U/L
Measured: 12 months
Biochemical test changes 2
Evaluation of variation of the biochemical tests panel based on normal ranges provided by the local laboratory. Multiple parameters are included in biochemical panel: alanine aminotransferase (ALT). Normal range: <45 U/L
Measured: 12 months
Biochemical test changes 3
Evaluation of variation of the biochemical tests panel based on normal ranges provided by the local laboratory. Multiple parameters are included in biochemical panel: Alkaline Phosphatase (range variable according to age and sex)
Normal range:
Females: 30 - 120 U/L Males: 30 - 120 U/L
Measured: 12 months
Biochemical test changes 4
Evaluation of variation of the biochemical tests panel based on normal ranges provided by the local laboratory. Multiple parameters are included in biochemical panel: Gamma-glutamyltransferase
Normal range:
Females: < 38 U/L Males: < 55 U/L
Measured: 12 months
Biochemical test changes 5
Evaluation of variation of the biochemical tests panel based on normal ranges provided by the local laboratory. Multiple parameters are included in biochemical panel: bilirubin Normal range: < 1.60 mg/dL
Measured: 12 months
Biochemical test changes 6
Evaluation of variation of the biochemical tests panel based on normal ranges provided by the local laboratory. Multiple parameters are included in biochemical panel: glycemia (glucose) Normal range: 70 - 105 mg/dL
Measured: 12 months
Biochemical test changes 7
Evaluation of variation of the biochemical tests panel based on normal ranges provided by the local laboratory. Multiple parameters are included in biochemical panel: HDL cholesterol
Normal range:
Females > 45 mg/dL Males > 35 mg/dL
Measured: 12 months
Biochemical test changes 8
Evaluation of variation of the biochemical tests panel based on normal ranges provided by the local laboratory. Multiple parameters are included in biochemical panel: LDL cholesterol
Normal range:
Very high risk: objective < 55 high risk: < 70 moderate risk: < 100 low risk: < 116
Measured: 12 months
Biochemical test changes 9
Evaluation of variation of the biochemical tests panel based on normal ranges provided by the local laboratory. Multiple parameters are included in biochemical panel: albumin Normal range: 35.0 - 50.0 g/L
Measured: 12 months
Biochemical test changes 10
Evaluation of variation of the biochemical tests panel based on normal ranges provided by the local laboratory. Multiple parameters are included in biochemical panel: total proteins Normal range: 6.6 - 8.3 g/dL
Measured: 12 months
Biochemical test changes 11
Evaluation of variation of the biochemical tests panel based on normal ranges provided by the local laboratory. Multiple parameters are included in biochemical panel: glicate hemoglobin Normal range: 20 - 42 mmol/mol
Measured: 12 months
Biochemical test changes 12
Evaluation of variation of the biochemical tests panel based on normal ranges provided by the local laboratory. Multiple parameters are included in biochemical panel: Vitamin D Normal range: 15.2 - 90.1 pg/mL
Measured: 12 months
Biochemical test changes 13
Evaluation of variation of the biochemical tests panel based on normal ranges provided by the local laboratory. Multiple parameters are included in biochemical panel: uric acid
Normal range:
Females 2.4 - 5.7 Males 3.4 - 7.0 mg/dL
Measured: 12 months
Fibrosis-4 test (FIB-4 ) variation
Liver biochemical biomarker (FIB4) variation
Measured: 12 months
NAFLD Fibrosis Score (NFS) change
Liver biochemical biomarker (NAFLD Fibrosis Score, NFS) change
Measured: 12 months
FAST (FibroScan-AST) score variation
Liver biochemical biomarker (FibroScan-AST) variation
Measured: 12 months
Fatty Liver Index (FLI) modification
Liver biochemical biomarker (Fatty Liver Index (FLI) modification
Measured: 12 months
Changes in LSM
Changes in physical liver biomarkers of fibrosis with Transient Elastometry (Fibroscan, Echosens, France) by reducing the kPa after treatment.
Measured: 12 months
Variation of steatosis by CAP
Changes in biomarker of fatty liver disease evaluated with the controlled attenuation parameter (CAP, Echosens, France) by the reduction of decibel/sec (dB/sec) after treatment
Measured: 12 months
Body Mass Index (BMI) improvement
Anthropometric parameters (BMI) improvement
Measured: 12 months
Side effects evaluation for VLCKD therapy by VAS (Visual Analogue Scale)
The tolerability measured by a VAS (Visual Analogue Scale) that assesses the occurrence of side effects in patients undergoing diet therapy with VLCKD. The lowest value (0) indicates the best result, while the highest value (10) indicates absence of tolerability.
Measured: 3 months
Compliance to VLCKD evaluated by VAS (Visual Analogue Scale)
The tolerability measured by a VAS (Visual Analogue Scale) that assesses the compliance of patients undergoing diet therapy with VLCKD. The lowest value (0) indicates the best result, while the highest value (10) indicates absence of tolerability.
Measured: 3 months
Variation of steatosis by ultrasound assessment
Physical biomarkers of hepatic steatosis evaluated by qualitative method (mild, moderate, severe) hepatic ultrasound.
Measured: 12 months
Questionnaires 1
Questionnaires on quality of life (Health-related quality of life, HRQoL). The answers follow this scheme: 1 ["best outcome"] to 3 ["worst outcome"].
Measured: 12 months
Questionnaires 2
Questionnaires on lifestyle (physical exercise/sedentary habits). A score is not provided.
Measured: 12 months
Questionnaires 3
Questionnaires on liver disease-related events (NASH-CHECK). 0=no pain, 10=worst pain.
Measured: 12 months
Questionnaires 4
Questionnaires on liver disease-related events (CLDQ). 1=always, 7=never.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start29 Sep 2021
- Primary completion24 Nov 2024 (estimated)
- Study completion12 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NASHStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentric, Prospective, Open, Randomized, Controlled, and Interventional, with no medicinal use
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabio Piscaglia, University of Bologna
- Investigators
- Fabio Piscaglia, Principal investigator, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06308757
- Sponsor's protocol ID
- 495/2021/Sper/AOUBo
- Acronym
- KETONASH
- Status last verified
- Mar 2024
- First submitted
- 19 Feb 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Very Low Calorie Ketogenic Diet (VLCKD) in Patients Affected by Non-Alcoholic Steatohepatitis (NASH) With Significant Fibrosis (KETONASH)
- ClinicalTrials.gov ID
- NCT06308757
- Acronym / sponsor ID
- KETONASH / 495/2021/Sper/AOUBo
- Conditions
- NASH, NAFLD, Obesity, Liver Fibrosis
- Keywords
- vlckd, diet, ketogenic diet
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- 29 Sep 2021 (actual)
- Primary completion
- 24 Nov 2024 (estimated)
- Study completion
- 12 Dec 2026 (estimated)
- First posted
- 13 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the KETONASH study is to evaluate, in patients with metabolic-associated fatty liver disease (MAFLD) with non-alcoholic steatohepatitis (NASH) and significant liver fibrosis, the effect of a very low-calorie ketogenic diet (VLCKD) compared to that of a standard low-calorie diet (standard Mediterranean LCD - in accordance with the European Association for the Study of the Liver/European Society for Clinical Nutrition and Metabolism guidelines on MAFLD/NAFLD).
Detailed description
The KETONASH study is a multicenter, open-label, randomised, controlled clinical trial that will be consecutively proposed to all patients with histological diagnosis of non-alcoholic steatohepatitis (NASH) and significant hepatic fibrosis in the context of chronic metabolic liver disease (MAFLD/NAFLD).
Once the inclusion criteria are confirmed and the exclusion criteria are ruled out, patients will be subsequently randomly assigned (randomisation) with a 2:1 ratio to one of the two study arms:
- VLCKD Study Arm → will receive experimental diet therapy with very low-calorie ketogenic meals (VLCKD) consisting of 5 successive phases (600 - 1500 kcal/day).
- LCD Control Arm → will receive standard low-calorie diet therapy, a Mediterranean-type diet in accordance with the most recent guidelines on MAFLD/NAFLD (1200-1500 kcal/day).
The KETONASH study consists of an initial 4-month diet intervention phase (Visits 1-8), followed by a second 8-month weight maintenance phase (Visits 9-15). In both study arms, the intervention will be conducted through a standardised multidisciplinary approach (Physician/Dietitian/Nurse/Psychologist) aimed at weight loss through changes in dietary regimen, exercise program, and emotional support techniques.
The two study arms differ in nutritional composition, types of foods, and caloric intake.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicentric, Prospective, Open, Randomized, Controlled, and Interventional, with no medicinal use
| Arm | Type | Receives |
|---|---|---|
| VLCKD arm | Experimental | Dietary Supplement: Very-low-calorie ketogenic diet (VLCKD) with meal replacementsThe VLCKD dietary intervention consists of five phases: Ketogenic Low-Calorie Period (2 months): * Phase 1 (30 days - Visits 1-3): Ketogenic diet with low-fat content, 600 kcal/day. * Phase 2 (15 days - Visit 5): 660 kcal/day. * Phase 3 (15 days - Visit 5): 730 kcal/day Low-Calorie Period (2 months): Phase 4 (30 days - Visits 6-7): Hypocaloric diet with the reintroduction of different foods, 1,050 kcal/day. - Phase 5 (30 days - Visits 7-8): 1,400 kcal/day. During these phases, the patient will receive nutritional supplementation with vitamins, trace elements, and omega-3 fatty acids. Throughout the very low-calorie ketogenic period, the patient will have three interim dietetic consultations (Visits 2-4) and a medical visit (Visit 5). During the low-calorie period, the patient will receive alternating two dietetic consultations (Visits 6 and 7) and one medical visit every 30 days (Visit 8). |
| Control LCD arm | Active comparator | Dietary Supplement: Mediterranean low-calorie diet (LCD)The control LCD arm consists of a diet with natural low-calorie foods (1200-1500 kcal/day or a reduction of 500-1000 kcal/day compared to baseline) and a low glycemic index based on the "Mediterranean Diet" model, following the most recent guidelines on MAFLD/NAFLD. Similar to the VLCKD arm, for the entire duration of the dietetic treatment, the patient will alternately receive dietetic consultations and medical visits. At the end of the dietary intervention, patients from both study arms will continue with a controlled, low glycemic index diet tailored to the patient's basal metabolic rate (BMR) (estimated with bioimpedance assessment) for an additional six months. Both study arms will follow a physical activity schedule and will have psychological-motivational support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged ≥18 years with histological diagnosis of NASH with evidence of fibrosis (defined according to NASH CRN) obtained no more than 6 months before enrollment;
- Stable weight for more than 6 months with BMI between 30-40 kg/m2;
- Patients in whom it is safe and feasible to proceed with liver biopsy and who consent to undergo liver biopsy after 12 months of enrollment to assess the effect of dietary treatment;
- Obtained informed consent.
Key exclusion criteria (12 listed)
- BMI <30 or BMI >40
- Presence of evolved chronic liver disease into cirrhosis (histological F4 or elastometric LSM >14 kPa)
- Type 1 diabetes mellitus
- Model for End-stage Liver Disease (MELD) score >12, AST or ALT ≥5× ULN, HbA1c >9.5%, INR ≥1.4, creatinine >1.5 mg/dl, platelets <100,000/mm3, and total bilirubin >1.5 mg/dl.
- Concurrent presence of any other known chronic liver disease beyond MAFLD/NAFLD, such as alcoholic liver disease, viral (HCV/HBV), cholestatic-autoimmune (PBC/PSC/AIH), Wilson's disease, hemochromatosis, drug-induced liver injury (DILI), or the presence or suspicion of hepatocellular carcinoma (HCC);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Very-low-calorie ketogenic diet (VLCKD) with meal replacementsThe VLCKD study arm will receive an experimental diet therapy with very-low-calorie ketogenic meal replacements (VLCKD) consisting of 5 successive phases (600 - 1500 kcal/day). | Dietary supplement | VLCKD arm |
| Mediterranean low-calorie diet (LCD)The Control arm LCD will receive standard Mediterranean type low-calorie diet (LCD) therapy by the most recent guidelines on MAFLD/NAFLD (1200-1500 kcal/day). | Dietary supplement | Control LCD arm |
Primary outcome
Change of at least one grade of liver fibrosis
Time frame: 12 months
Histological change of liver fibrosis without worsening of NASH
Change of histological features of NASH
Time frame: 12 months
NASH parameters variation. Improvement in disease activity is defined as decrease in NAFLD Activity Score (NAS) ≥1 points. The worsening of fibrosis is defined as any numerical increase in the stage.
29 secondary outcomes
Histological NIH NASH CRN Score
Time frame: 12 months
Histological FLIP/SAF changes
Time frame: 12 months
Biochemical test changes 1
Time frame: 12 months
Biochemical test changes 2
Time frame: 12 months
Biochemical test changes 3
Time frame: 12 months
Biochemical test changes 4
Time frame: 12 months
Biochemical test changes 5
Time frame: 12 months
Biochemical test changes 6
Time frame: 12 months
Biochemical test changes 7
Time frame: 12 months
Biochemical test changes 8
Time frame: 12 months
Biochemical test changes 9
Time frame: 12 months
Biochemical test changes 10
Time frame: 12 months
Biochemical test changes 11
Time frame: 12 months
Biochemical test changes 12
Time frame: 12 months
Biochemical test changes 13
Time frame: 12 months
Fibrosis-4 test (FIB-4 ) variation
Time frame: 12 months
NAFLD Fibrosis Score (NFS) change
Time frame: 12 months
FAST (FibroScan-AST) score variation
Time frame: 12 months
Fatty Liver Index (FLI) modification
Time frame: 12 months
Changes in LSM
Time frame: 12 months
Variation of steatosis by CAP
Time frame: 12 months
Body Mass Index (BMI) improvement
Time frame: 12 months
Side effects evaluation for VLCKD therapy by VAS (Visual Analogue Scale)
Time frame: 3 months
Compliance to VLCKD evaluated by VAS (Visual Analogue Scale)
Time frame: 3 months
Variation of steatosis by ultrasound assessment
Time frame: 12 months
Questionnaires 1
Time frame: 12 months
Questionnaires 2
Time frame: 12 months
Questionnaires 3
Time frame: 12 months
Questionnaires 4
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fabio Piscaglia principal investigator
University of Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Very-low-calorie ketogenic diet (VLCKD) with meal replacements and Mediterranean low-calorie diet (LCD) in people with NASH and NAFLD, run by University of Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fabio Piscaglia, MD, PhD, Professor (0512142214, fabio.piscaglia@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of at least one grade of liver fibrosis (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.