Non-Alcoholic Fatty Liver Disease Clinical Trial
Official title:
The Effect of an Enhanced Rice Bran Nutritional Supplement on Non-Alcoholic Fatty Liver Disease (NAFLD)
The purpose of this study is to investigate the effects of Rice Bran Arabinoxylan Compound (RBAC) on outcome variables in persons with non-alcoholic fatty liver disease (NAFLD). This nutritional supplement is made from a water soluble extract of rice bran that has been partially hydrolyzed by the action of a natural enzyme complex extracted from Shiitake mushroom.
The purpose of this study is to investigate the effects of Rice Bran Arabinoxylan Compound
(RBAC) on outcome variables in persons with non-alcoholic fatty liver disease (NAFLD). This
nutritional supplement is made from a water soluble extract of rice bran that has been
partially hydrolyzed by the action of a natural enzyme complex extracted from Shiitake
mushroom. Given that these micronutrients may be important for regulating the immune system,
investigators will investigate the impact of RBAC on the following variables among 20 adults
(18+ years of age and over) diagnosed with NAFLD:
1. albumin
2. 4-hydroxynonenal
3. lipids
4. liver enzymes (alanine aminotransferase (ALT), aspartate aminotransferase (AST), and
alkaline phosphatase (ALP)
5. malondialdehyde
6. γ-glutamyltransferase
7. cytokines (TNF-α, LT-α, IL-1α, IL-1β, IL-6, TNF-RI, TNF-RII, IFN-γ, IL-12, IL-2, IL-15,
IL-8, IL-4, IL-5, IL-17, IL-23, IL-10, IL-13, and IL-18)
8. lymphocytes
9. platelets
Specifically, subjects will participate in a 3-month, two-group, randomized intervention,
where one group (n=10) will take 1 gram/day RBAC and the other group (n=10) will take a
placebo to compare differences in outcomes between the two groups. The results of the study
are intended to address the multi-faceted physiological problems of NAFLD patients by
testing the efficacy of a nutritional supplement intervention on multiple outcomes in this
population.
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