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Ketogenic Diet in MASLD-related cACLD

ConditionsSteatohepatitis, NonalcoholicSteatosis of LiverCirrhosis, Liver
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Palermo

About this trial

The investigators hypothesize that very low ketogenic diet could represent a new therapeutic option in the management of patients with MASLD and cACLD. Therefore, the investigator propose a randomized controlled study that evaluates the impact of two dietary protocols -Mediterranean diet, and very low ketogenic diet- the MD and the VLCKD, in individuals with cACLD secondary to MASLD.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients older than 18 years

Pattients with cACLD secondary MASLD. Specifically cACLD is defined as liver stiffness ≥10 KPa by Transient Elastography and/or fibrosis F3 or F4 at liver biopsy by Kleiner scoring system; MASLD is defined by the presence of steatosis and at least one of five cardiometabolic risk factor.

Informed consent form obtained before any trial-related ac.vity.

Disqualifiers

Concomitance of any other chronic liver disease: Wilson's disease (normal serum ceruloplasmin); alpha-1-an.trypsin deficiency (normal serum alpha-1-an.trypsin); viral hepatitis (anti-HCV and HBsAg negativity); primary biliary cirrhosis (ANA<1:160 and AMA negativity); autoimmune hepatitis (ANA, SMA and LKM <1:160), . .

MetALD: patients with metabolic dysfunc.on-associated steato.c liver disease, who consume amounts of alcohol per week (140-350 g/wk and 210-420 g/wk for females and males, respectively.

History of or planned gastrointestinal bypass or any additional bariatric surgery/intervention.

Recent significant weight loss ( > 5 % within previous 6 months)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mediterranean diet

    Dietary supplement

    This equilibrated diet has a caloric value 10% below the total metabolic expenditure of each individual. The total metabolic expenditure is calculated from the basal metabolic expenditure (based on the formula FAO/WHO/UN) multiplied by the coefficient of activity, which is calculated according to the physical activity of each participant. The calories provide to this group range between 1,400 and 1,800 kcal/day. The ration of macronutrients provided is 45-55 % arbohydrates,15-25 % proteins, and 25-35 % fat, in addition to a recommended intake of 20-40 g/day of fiber in the form of vegetables and fruits.

  • Very Low Ketogenic Diet

    Dietary supplement

    The VLCKD ketogenic protocol entails: a caloric intake \< 800 calories, a protein intake calculated based on individual needs: 1.2 + 0.2 g/kg/ideal body weight, low carbohydrate content (approximately 45-55 g of carbohydrates per day), and low lipids (10-15g/day). Vitamins and minerals, Unlimited vegetables.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Mediterranean DietActive comparator 1 intervention
Group B: Very Low Ketogenic DietExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

weight loss≥10% compared to the initial weight in individuals with cACLD secondary to MASLD

Weight in Kg

Time frame
48 weeks

Secondary outcomes

1

▪ changes in liver stiffness by Magnetic Resonance Elastography (MRE)

MRE in KPa

Time frame
48 weeks
2

▪ changes in liver fat by Magnetic Resonance Imaging-proton density fat fraction (MRI-PDFF)

MRI-PDFF in %

Time frame
48 weeks
3

▪ changes in liver stiffness by transient elastography

Liver Stiffness in KPa

Time frame
48 weeks
4

▪ changes in liver fat by controlled attenuation parameter (CAP)

CAP in dB/m

Time frame
48 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Palermo

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: