Effect of LIVOGEN, a nutraceutical containing natural bioactive components bergamot extract, artichoke leaf extract, Nigella sativa, EPA, DHA and silybin, on individuals affected by liver steatosis (fatty liver disease)

LIVOGEN in liver steatosis

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN70887063

Enrollment

140

Registered

2021-09-02

Start date

2021-07-12

Completion date

Unknown

Last updated

2022-09-05

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

Conditions

Liver steatosis Digestive System Nonalcoholic fatty liver disease [NAFLD]

Interventions

Participants will be enrolled after a written informed consent will be obtained and will be randomly assigned (by computer-generated random numbers) in a 1:1 ratio to receive either the nutraceutical

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. NAFLD defined by a CAP score value =247 dB/m 2. Age 30 - 75 years

Exclusion criteria

Exclusion criteria: 1. Taking nutraceuticals, supplements or functional food 2. Past and current alcohol abuse 3. Clinical and laboratory signs of chronic hepatitis B and/or C virus infection 4. Allergies to nutraceuticals components 5. Diabetes 6. Autoimmune or cholestatic liver disease, liver cirrhosis, 7. Pregnancy 8. Nephrotic syndrome, chronic renal failure 9. Gastroesophageal reflux 10. Cancer 11. Taking amiodarone, antiretroviral agents, corticosteroids, methotrexate, tamoxifen, valproate 12. Starting lipid-lowering drugs in the past month

Design outcomes

Primary

Measure	Time frame
1. CAP score value will be measured by Fibroscan at baseline and after 12 weeks of treatment 2. Serum lipid (cholesterol, HDL-cholesterol, and triglycerides) profile will be assessed by chemiluminescent immunoassay at baseline and after 12 weeks of treatment 3. AST, ALT, and GGT will be measured by chemiluminescent immunoassay at baseline and after 12 weeks of treatment Insulin will be determined by chemiluminescent immunoassay at baseline and after 12 weeks of treatment 4. C-reactive protein (CRP) will be measured by chemiluminescent immunoassay at baseline and after 12 weeks of treatment. 5. Serum interleukin-1ß (IL-1ß), interleukin-6 (IL-6), and tumor necrosis factor a (TNF-a) will be determined by sandwich enzyme-linked immunosorbent assay (ELISA) at baseline and after 12 weeks of treatment at baseline and after 12 weeks of treatment.	—

Measure

Time frame

1. CAP score value will be measured by Fibroscan at baseline and after 12 weeks of treatment 2. Serum lipid (cholesterol, HDL-cholesterol, and triglycerides) profile will be assessed by chemiluminescent immunoassay at baseline and after 12 weeks of treatment 3. AST, ALT, and GGT will be measured by chemiluminescent immunoassay at baseline and after 12 weeks of treatment Insulin will be determined by chemiluminescent immunoassay at baseline and after 12 weeks of treatment 4. C-reactive protein (CRP) will be measured by chemiluminescent immunoassay at baseline and after 12 weeks of treatment. 5. Serum interleukin-1ß (IL-1ß), interleukin-6 (IL-6), and tumor necrosis factor a (TNF-a) will be determined by sandwich enzyme-linked immunosorbent assay (ELISA) at baseline and after 12 weeks of treatment at baseline and after 12 weeks of treatment.

—

Secondary

Measure	Time frame
There are no secondary outcome measures	—

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 11, 2026