None listed
Conditions
Brief summary
Acute alcoholic injury liver is a substantial medical problem originating from accumulation in the blood and tissues ethanol and acetaldehyde. Even single intake of ethanol-containing beverages is accompanied by poorly reversible abnormalities of hepatic and neurological functions. Systematic consumption of ethanol-containing drinks leads to the development of alcoholic steatohepatitis, portal hypertension, and results in higher mortality of drinkers. Besides direct toxic effect of alcohol and its metabolites on hepatocytes and other cells, there is well acknowledged role of free radicals and lipid peroxidation products in alcoholic injury. Therefore, use of antioxidants, such as lycopene, , as well as use of membrane-stabilizing agents, such as phosphatidylcholine, may have a substantial preventive impact on acute alcoholic injury of the liver. A combined, highly bioavailable nutraceutical formulation of lycopene and phosphatidylcholine, in which lycopene is chaperoned by phospholipid, is in the scope of the present clinical trial which is aimed at the prevention of acute hepatic injury after single alcohol intake.
Interventions
Healthy volunteers aged 30-60 years will go through 6 different intervention challenges performed by oral intake of alcohol-containing beverage consumed sententiously with an oral capsule of tested product (placebo or PC lycosome formulation).
The order in which each participant completes the challenges will be randomized.
First three challenges will be conducted with one-week intervals.
After one-month rest three other challenges will be performed with the similar one week interval.
Chall
Healthy volunteers aged 30-60 years will go through 6 different intervention challenges performed by oral intake of alcohol-containing beverage consumed sententiously with an oral capsule of tested product (placebo or PC lycosome formulation). The order in which each participant completes the challenges will be randomized. First three challenges will be conducted with one-week intervals. After one-month rest three other challenges will be performed with the similar one week interval. Challenge 1. Ingestion of a placebo pill with simultaneous intake of the first dose of moderate amount of alcohol (0.5 g/kg). Challenge 2. Ingestion of unmodified phosphatidylcholine (PC) formulation containing 450 mg of PC with a simultaneous intake of moderate amount of alcohol (0.5 g/kg). Challenge 3. Ingestion of phosphatidylcholine lycosomes PC-L 450 mg and lycopene 7mg with simultaneous intake of moderate amount of alcohol (0.5 g/kg). One month rest period will take place. Challenge 4. Ingestion of a placebo pill with simultaneous intake of the second dose of alcohol (1.0 g/kg). Challenge 5. Ingestion of unmodified phosphatidylcholine (PC) formulation containing 450 mg of PC with a simultaneous intake of second dose of alcohol (1.0 g/kg). Challenge 6. Ingestion of phosphatidylcholine lycosomes PC-L 450 mg and lycopene 7mg with simultaneous intake with the second dose of alcohol (1.0 g/kg). All formulations will be taken once during iso-caloric breakfast 1 hour before moderate alcohol intake. Adherence to the protocol will be verified by questioning the patients and laboratory tests (measurements of phosphatidylcholine and/or lycopene metabolites in blood).
Sponsors
Lycotec Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
30 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy volunteers aged 30-60 years of both genders with no outstanding health problems, acute or chronic diseases
Exclusion criteria
1. Current alcohol use exceeding 2 drinks per week,. 2. Patients with any heart, liver or neurological disease. 3. Anamnestic indication of long-term alcohol use in the past. 4. Patients with acute kidney injury at the time of enrollment 5. Patients with CKD (Chronic Kidney Disease) or with Creatinine level > 1 mg/dL. 5. Patient with platelet count <100.000/mm3
Outcome results
None listed