The Effect of an Enhanced Rice Bran Nutritional Supplement on Non-Alcoholic Fatty Liver Disease (NAFLD)

Investigator: John Lewis

Institutional Protocol #: 20150512

National Clinical Trials Identifier: NCT02568787

Funding Agency/Sponsor: Daiwa Health Development

Division: Psychiatry

Therapeutic Area: Other

Phase: N/A

Enrolling Sites: University of Miami Medical Group

Enrolling Since: 6/17/2016


Purpose/Abstract:


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.




Eligibility Criteria:


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


Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Accepts healthy volunteers: Accepts Healthy Volunteers

Please note that this is written for scientific review, and if there are any questions or clarifications needed, please contact

John Lewis, Research Assoc. Professor
(305) 243 6227
jlewis2@miami.edu

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