The Effect of an RBAC Supplement (BRM4) on 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. 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.

Inclusion Criteria:

1. Age 18 or older

2. Confirmed NAFLD diagnosis

3. On a stable medication regimen during the intervention

4. Planning to maintain current medication during the course of the intervention

5. Willing to have blood drawn

6. Previous nutritional supplement usage of similar polysaccharide formula permitted,
but current use must be stopped 2 weeks before and during trial

7. Interested in participating in a dietary supplement study

8. Willing to follow recommendations for participating in the study

9. Willing to not consume food, alcohol, caffeine, or stimulants (amphetamines) 12 hours
before each assessment

10. Able to provide informed consent

Exclusion Criteria:

1. Currently enrolled in another research trial for similar investigative nutritional
therapies

2. Known allergy to rice, rice bran, mushrooms, or related food products

3. Any gastrointestinal disorders that could lead to uncertain absorption of the study
supplement

4. Taking any lipid-lowering agent for the prior 3 months before study enrollment

5. Currently taking immunomodulatory medication, i.e., interferon

6. Currently taking chemotherapeutic agents

7. Severe anemia or other medical condition that will not permit a safe blood draw

8. A bleeding disorder

9. A terminal illness

10. Women who are pregnant or are attempting conception, especially in the presence of a
history of recurrent spontaneous abortion

11. Currently undergoing internal defibrillation, like with an implantable heart device

12. Erratic, accelerated, or mechanically controlled irregular heart rhythms

13. Atrial fibrillation/flutter

14. Atrioventricular block

15. Recently had dyes introduced into the bloodstream, such as methylene blue,
indocyanine green, indigo carmine, and fluorescein

16. Any implanted electronic device