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Trial registered on ANZCTR


Registration number
ACTRN12617001335381
Ethics application status
Approved
Date submitted
17/07/2017
Date registered
20/09/2017
Date last updated
20/09/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of phosphatidylcholine lycosomes on metabolic parameters of liver
function after single intake of moderate amount of alcohol.
Scientific title
The effect of phosphatidylcholine lycosomes on metabolic parameters of liver
function after single intake of moderate amount of alcohol in healthy volunteers.
Secondary ID [1] 292318 0
None
Universal Trial Number (UTN)
U1111-1198-5601
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
acute liver injury 303868 0
metabolic liver functions 303870 0
Condition category
Condition code
Oral and Gastrointestinal 303224 303224 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Diet and Nutrition 303225 303225 0 0
Other diet and nutrition disorders
Injuries and Accidents 303226 303226 0 0
Poisoning

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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).

Intervention code [1] 298500 0
Prevention
Comparator / control treatment
Ingestion of placebo pill with simultaneous intake of moderate amount of alcohol (challenge 1 and 4) will serve as comparators for challenges 2,3 and 5,6 respectively.
Control group
Placebo

Outcomes
Primary outcome [1] 302610 0
Changes in blood levels of liver-specific enzymes (ALT, AST, LDH) after single intake of moderate amount of alcohol
Timepoint [1] 302610 0
before and 1, 2.5 and 5 hours after single intake of moderate amount of alcohol
Primary outcome [2] 302611 0
changes in the blood levels of ethanol after single intake of moderate amount of alcohol
Timepoint [2] 302611 0
before and 1, 2,5 and 5 hours after single intake of moderate amount of alcohol
Primary outcome [3] 303070 0
changes in the blood levels of acetaldehyde after single intake of moderate amount of alcohol
Timepoint [3] 303070 0
before and 1, 2,5 and 5 hours after single intake of moderate amount of alcohol
Secondary outcome [1] 336491 0
changes in blood bilirubin level after single intake of moderate amount of alcohol
Timepoint [1] 336491 0
before and 1, 2,5 and 5 hours after single intake of moderate amount of alcohol
Secondary outcome [2] 336492 0
changes in serum C-reactive protein levels after single intake of moderate amount of alcohol
Timepoint [2] 336492 0
before and 1, 2,5 and 5 hours after single intake of moderate amount of alcohol
Secondary outcome [3] 336493 0
changes in the malonic dialdehyde level in blood after single intake of moderate amount of alcohol
Timepoint [3] 336493 0
before and 1, 2,5 and 5 hours after single intake of moderate amount of alcohol
Secondary outcome [4] 337819 0
changes in oxidized LDL level in blood after single intake of moderate amount of alcohol
Timepoint [4] 337819 0
before and 1, 2,5 and 5 hours after single intake of moderate amount of alcohol
Secondary outcome [5] 337820 0
changes in blood glucose level after single intake of moderate amount of alcohol
Timepoint [5] 337820 0
before and 1, 2,5 and 5 hours after single intake of moderate amount of alcohol

Eligibility
Key inclusion criteria
Healthy volunteers aged 30-60 years of both genders with no outstanding health problems, acute or chronic diseases
Minimum age
30 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Consented volunteers with will be selected and coded with individual codes containing three numerical numbers and three letters.
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerized sequence generation will be used in the study
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample size was determined based on preliminary results obtained in a pilot clinical trial. Sample size was calculated based on the standard deviation values. Major statistical requirement were as follows: significance of probability in one-tailed test was taken as 2.5%; the statistical power level was chosen as 90%. The enrollment goal was set at 30 volunteers due to possible drop-outs.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2017
Actual
Date of last participant enrolment
Anticipated
1/10/2017
Actual
Date of last data collection
Anticipated
1/12/2017
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 9032 0
Russian Federation
State/province [1] 9032 0
Saratov

Funding & Sponsors
Funding source category [1] 296863 0
Commercial sector/Industry
Name [1] 296863 0
Lycotec Ltd
Country [1] 296863 0
United Kingdom
Primary sponsor type
Commercial sector/Industry
Name
Lycotec Ltd
Address
Platinum Building, Granta Park Campus, Cambridge, Cambridgeshire, CB21 6GP.
Country
United Kingdom
Secondary sponsor category [1] 295867 0
University
Name [1] 295867 0
Saratov State University, Institute of Cardiology
Address [1] 295867 0
Saratov State University
Institute of Cardiology
Chernushevskogo Str 14,
Saratov 321037
Country [1] 295867 0
Russian Federation

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298090 0
Ethical Committee, Institute of Cardiology
Ethics committee address [1] 298090 0
Institute of Cardiology
Chernushevskogo Str 14,
Saratov 321037
Ethics committee country [1] 298090 0
Russian Federation
Date submitted for ethics approval [1] 298090 0
01/06/2017
Approval date [1] 298090 0
15/06/2017
Ethics approval number [1] 298090 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75954 0
Dr Ivan M Petyaev MD, PhD
Address 75954 0
Lycotec Ltd,
Platinum Building, Granta Park Campus,
Cambridge, Cambridgeshire, CB21 6GP.
Country 75954 0
United Kingdom
Phone 75954 0
+447921363740
Fax 75954 0
Email 75954 0
ykb75035@aol.com
Contact person for public queries
Name 75955 0
Yuriy K Bashmakov
Address 75955 0
Lycotec Ltd,
Platinum Building, Granta Park Campus,
Cambridge, Cambridgeshire, CB21 6GP.
Country 75955 0
United Kingdom
Phone 75955 0
+447921363740
Fax 75955 0
Email 75955 0
ykb75035@aol.com
Contact person for scientific queries
Name 75956 0
Yuriy K Bashmakov MD, PhD
Address 75956 0
Lycotec Ltd,
Platinum Building, Granta Park Campus, Cambridge,
Cambridgeshire, CB21 6GP.
Country 75956 0
United Kingdom
Phone 75956 0
+447921363740
Fax 75956 0
Email 75956 0
ykb75035@aol.com

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