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Trial registered on ANZCTR


Registration number
ACTRN12615000386538
Ethics application status
Approved
Date submitted
15/01/2015
Date registered
28/04/2015
Date last updated
28/04/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of lycopene chaperoned with phosphatidylcholine on progression and outcomes of nonalcoholic steatohepatitis.
Scientific title
The effect of lycopene chaperoned with phosphatidylcholine on progression and outcomes of nonalcoholic steatohepatitis.
Secondary ID [1] 285947 0
none
Universal Trial Number (UTN)
U1111-1165-9370
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
steatohepatitis 293878 0
Condition category
Condition code
Alternative and Complementary Medicine 294677 294677 0 0
Herbal remedies
Oral and Gastrointestinal 295148 295148 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Metabolic and Endocrine 295149 295149 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The patients with steatohepatitis will divided into two groups (40 patients each):
Arm 1 (Group One). Ingestion of phosphatidylcholine (PC) chaperone formulation containing 450 mg of PC.
Arm 2. Ingestion of lycopene (7mg) fused with phosphatidylcholine (PC) chaperone (450 mg of PC).
Both formulations will be taken orally twice a day after meals during 6 month period.
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] 290922 0
Treatment: Other
Comparator / control treatment
Intake of phosphatidylcholine chaperone formulation without lycopene will serve as a comparator for the lycopene PC-chaperone study group.
Control group
Active

Outcomes
Primary outcome [1] 293971 0
Liver size changes registered by computed tomography
Timepoint [1] 293971 0
end of the 6th months of interventional period
Secondary outcome [1] 312257 0
changes in plasma levels of liver-specific enzymes (ALT, AST and other)
Timepoint [1] 312257 0
end of the 6th month of interventional period
Secondary outcome [2] 312258 0
changes in plasma levels of pro-inflammatory markers (CRP, adiponectin, IL-6 and IL-10)
Timepoint [2] 312258 0
end of the 6th month of interventional period

Eligibility
Key inclusion criteria
Patients with the definite or probable nonalcoholic steatohepatitis based on the results of computed tomography and laboratory tests.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Current alcohol use for a period of 3 consecutive months.
2. Patients with heart failure.
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
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Consented patients with confirmed steatohepatitis will be selected and coded with individual codes containing three numerical numbers and three letters. At the end of the recruitment period each patients will be allocated to the one of the group study using computerized simple randomization model. Patients from the first arm of the study will receive a phosphatidylcholine (PC) chaperon alone, while patients from the second arm of the study will be given PC-chaperone fused with lycopene.
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization program Biostat-2 will be used for computerized randomization of the consented patients.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
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%. Twenty five patients are required for each arm of the study. The enrollment goal was set at 40 patients per group due to possible drop-outs. Values for standard deviation in the previously conducted pilot clinical trial were as follows: control group (n=10, ALT - 5.5 U/l, AST - 3,7 U/l). nonalcoholic steatohepatitis (n=10, ALT- 12.5 U/l, AST - 7,3 U/l).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/01/2015
Actual
19/02/2015
Date of last participant enrolment
Anticipated
4/05/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 6586 0
Uzbekistan
State/province [1] 6586 0

Funding & Sponsors
Funding source category [1] 290530 0
Commercial sector/Industry
Name [1] 290530 0
Lycotec Ltd
Country [1] 290530 0
United Kingdom
Primary sponsor type
Commercial sector/Industry
Name
Lycotec Ltd, Cambridge, UK
Address
Platinum Building, Granta Park Campus, Cambridge, Cambridgeshire, CB21 6GP.
Country
United Kingdom
Secondary sponsor category [1] 289224 0
Charities/Societies/Foundations
Name [1] 289224 0
NUTRA Sp. Z.o.o.
Address [1] 289224 0
Ul. Rydygiera 8 building 3A
01-791 Warsaw, Poland
Country [1] 289224 0
Poland
Secondary sponsor category [2] 289242 0
Government body
Name [2] 289242 0
Institute of Immunology UzAS
Address [2] 289242 0
Y.Gulomov str. 74, Tashkent, Uzbekistan, 127004
Country [2] 289242 0
Uzbekistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292179 0
Institutional Review Board, Institute of Immunology UzAS
Ethics committee address [1] 292179 0
74 Gulomov Str, Tashkent, Uzbekistan, 127004
Ethics committee country [1] 292179 0
Uzbekistan
Date submitted for ethics approval [1] 292179 0
22/10/2014
Approval date [1] 292179 0
20/11/2014
Ethics approval number [1] 292179 0
122-74/32

Summary
Brief summary
Steatohepatitis treatment is a challenging task in the modern internal medicine. Diet, exercise and antiglycemic drugs are among pharmacological options in the NASH treatment. There is a recent piece of evidence that vitamin and possibly other antioxidants therapy may attenuate steatohepatitis development. That is why use of antioxidants, including lycopene, may represent a novel strategy in management of steatohepatitis. We hypothesize that ingestion of highly bio-available lycopene chaperoned with phosphatidylcholine may improve hepatic functions and inflammatory status in patients with non-alcoholic steatohepatitis.
Trial website
Lycotec.com
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42238 0
Dr Malika R Ruzibakieva, MD, PhD
Address 42238 0
Institute of Immunology UzAS, Y.Gulomov str. 74, Tashkent, Uzbekistan 111004
Country 42238 0
Uzbekistan
Phone 42238 0
tel/fax:+998712330855
Fax 42238 0
tel/fax:+998712330855
Email 42238 0
[email protected]
Contact person for public queries
Name 42239 0
Dr Ivan Petyaev
Address 42239 0
Lycotec Ltd, Platinum Building, Granta Park Campus, Cambridge, CB21 6GP, Cambridgeshire
Country 42239 0
United Kingdom
Phone 42239 0
+447921363740
Fax 42239 0
Email 42239 0
[email protected]
Contact person for scientific queries
Name 42240 0
Dr Yuriy Bashmakov
Address 42240 0
Lycotec Ltd, Platinum Building, Granta Park Campus, Cambridge, CB21 6GP, Cambridgeshire
Country 42240 0
United Kingdom
Phone 42240 0
+447921363740
Fax 42240 0
+447921363740
Email 42240 0
[email protected]

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