The main aim of the study is to determine if an oral supplementation of the LCS has a beneficial effect by itself or even enhances the beneficial effects of a moderate life-style intervention on the progression of NAFLD in humans.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Nutritional counseling by a trained nutritionist for 12 weeks.
The dietary supplement LCS (Yakult plus) will be given 2 times a day for 12 weeks in addition to dietary counseling every 3 weeks.
Nutritional counseling by a trained nutritionist in addition to the dietary supplement LCS (2 times a day) for 12 weeks.
Institut für Ernährungswissenschaften, University Jena
Jena, Germany
University Medical Center of the Johannes Gutenber Univeristy
Mainz, Germany
Reduction of the M30 antigen in the serum
Reduction of the M30 antigen as a validated measure of the degree of hepatocellular inflammation and injury
Time frame: 12 and 24 weeks
Change in indicators of hepatocellular injury and fibrosis
Change in indicators of hepatocellular injury (ALT, gammaGT, M30/M60 antigen ratio, ELF score), proinflammatory cytokines (hsCRP, ferritin, plasminogen activator-1, endotoxin), surrogate parameters of liver fibrosis (fibrosis marker panels, Fibrotest, ELF score) and relative liver stiffness (assessed by Fibro Scan)
Time frame: 12 and 24 weeks
Change in metabolic risk factors
Changes in metabolic risk factors (BMI, waist circumference, Homeostasis Model Assessment/Matsuda Score, serum lipids), changes in oral glucose tolerance and changes in hepatic steatosis will be assessed.
Time frame: 12 and 24 weeks
Saftey and tolerability
Safety is assessed by (1) clinical examination, (2) clinical chemistries including serum electrolytes, renal, liver function tests and markers of pancreatic injury.
Time frame: 12 and 24 weeks
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