Effect of lycopene chaperoned with phosphatidylcholine on progression and outcomes of nonalcoholic steatohepatitis.

The effect of lycopene chaperoned with phosphatidylcholine on progression and outcomes of nonalcoholic steatohepatitis.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615000386538

Enrollment

Registered

2015-04-28

Start date

2015-02-19

Completion date

2015-05-04

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

Patients with the definite or probable nonalcoholic steatohepatitis based on the results of computed tomography and laboratory tests.

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

Outcome results