Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Miami, Florida 33136


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT02568787


Primary Contact:

Principal Investigator
John E Lewis, Ph.D.
University of Miami


Backup Contact:

N/A


Location Contact:

Miami, Florida 33136
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.