Metabolic Effects of Very Low Carbohydrate Ketogenic Diet in Subjects With Severe Obesity

  • End date
    Dec 31, 2022
  • participants needed
  • sponsor
    University Of Perugia
Updated on 4 March 2022
fatty liver
morbid obesity
ketogenic diet
Accepts healthy volunteers


The very low carbohydrates diet (VLCKD) induces liver steatosis amelioration. Lysosomal acid lipase (LAL) deficiency plays a role in fats accumulation in liver. To date, no studies have assessed LAL activity in morbid obesity. The aim of our study is to evaluate VLCKD impact on metabolic/vascular parameters and LAL activity in obese patients.

A VLCKD is administered for 25 days to 52 morbid obese patients (BMI 44.78.3 kg/m, age 4912.5 years); at baseline and after diet we evaluated: BMI, glyco-lipidic pattern, abdominal ultrasonography (liver steatosis and visceral fat area) and flow-mediated dilation (FMD). In a subgroup of 20 patients we also tested lysosomal acid lipase (LAL)-activity. A group of healthy normal weight subjects (age 4313, BMI 22.82.6 kg/m) was also included in the study.

Condition Lysosomal Acid Lipase Deficiency, Obesity, Ketogenic Dieting, Ketosis
Clinical Study IdentifierNCT03564002
SponsorUniversity Of Perugia
Last Modified on4 March 2022


Yes No Not Sure

Inclusion Criteria

BMI > 40 Kg/m2 or > 35 kg/m2 with comorbidities

Exclusion Criteria

Type-2 diabetes
Kidney, heart or liver failure
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