Use of reservatrol for the treatment of non-alcoholic fatty liver disease (NAFLD)

11234,943

16/327708

August 25, 2017

Micronized trans-resveratrol is provided in 50-200 mg unit dosage form for use as a single unit dose daily for administration to human patients the treatment or prevention of non-alcoholic fatty liver disease and/or for the treatment, prevention or reversal of non-alcoholic hepatic steatosis, e.g. for administration to patients exhibiting evidence of fatty liver on ultrasonography. A reported study shows the effects of resveratrol micronized formulation in reducing the liver fat, decreasing hepatic enzymes, serum glutamate pyruvic transaminase (SGPT) and gamma-glutamyl transpeptidase (g-GT) and decreasing insulin resistance. At the end of the study, statistical analysis showed a strongly statistically significant reduction in the liver fat, which in some patients continued for an extended period after treatment was discontinued. These results demonstrate that use of resveratrol in micronized formulation improves features of NAFLD, prevents liver damage and that resveratrol micronized formulation can be an effective treatment for NAFLD.

Theodotou, Marios Andreou (Limassol, CY)

1. A method of treating a human patient exhibiting non-alcoholic hepatic steatosis associated with fatty liver disease by administering over a period of at least 6 months a micronized trans-resveratrol composition to give a daily dosage of 50-200 mg, said composition consisting essentially of the micronized trans-resveratrol, one or more dry pharmaceutically acceptable excipients selected from soybean powder, starch, colloidal silicon dioxide, microcrystalline cellulose and sodium starch glycolate and also comprising lactose which acts as a filler, at least 90% of the micronized trans-resveratrol particles having a diameter of less than 25 μm, at least 50% of the micronized trans-resveratrol particles having a diameter of less than 5 μm and at least 10% of the micronized trans-resveratrol particles having a diameter of less than 2 μm, said composition being in unit dosage form in the form of capsules, wherein administration reverses the non-alcoholic hepatic steatosis giving a reduction in liver fat observable by ultrasound measurements and said reversal persists for at least 6 months after the end of the treatment period.

2. The method of claim 1 , wherein it has been prior ascertained that the patient exhibits evidence of fatty liver on ultrasonography.

3. The method of claim 2 , wherein it has been prior ascertained that the patient exhibits one or more of: (a) diffuse enhancement of near field echo in the hepatic region (stronger than in the kidney and in the spleen region) and gradual attenuation of the far field echo, (b) unclear display of intra-hepatic lacuna structure, (c) mild to moderate hepatomegaly with a round and blunt border and/or (d) unclear display of envelope of right liver lobe and diaphragm.

4. The method of claim 1 , wherein the period of persistence after the end of the treatment period is at least 2.5 years.

5. A method of treating a human patient exhibiting non-alcoholic hepatic steatosis associated with fatty liver disease by administering over a period of at least 6 months a micronized trans-resveratrol composition to give a daily dosage of 50-200 mg, said composition consisting essentially of the micronized trans-resveratrol, one or more dry pharmaceutically acceptable excipients and a filler, at least 90% of the micronized trans-resveratrol particles having a diameter of less than 25 μm, at least 50% of the micronized trans-resveratrol particles having a diameter of less than 5 μm and at least 10% of the micronized trans-resveratrol particles having a diameter of less than 2 μm, said composition being in unit dosage form in the form of capsules, wherein administration reverses the non-alcoholic hepatic steatosis giving a reduction in liver fat observable by ultrasound measurements and said reversal persists for at least 6 months after the end of the treatment period.

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