Clinical trial · Interventional
The Effect of an RBAC Supplement (BRM4) on NAFLD
The Effect of an Enhanced Rice Bran Nutritional Supplement on Non-Alcoholic Fatty Liver Disease (NAFLD)
NCT02568787CI-TRIAL-00028095completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Alcoholic Fatty Liver Disease | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Dietary Supplement | — | UNRESOLVED |
| rice bran arabinoxylan compound (RBAC) | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Rice bran arabinoxylan compound (RBAC)
- description
- Take 2 tablets 1 time (1 gram) per day for the 3-month intervention period.
- interventionNames
- Dietary Supplement: rice bran arabinoxylan compound (RBAC)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Take 2 tablets 1 time (1 gram) per day for the 3-month intervention period.
- interventionNames
- Dietary Supplement: Placebo
Primary outcomes (3)
- measure
- Change from baseline in liver function test
- timeFrame
- Baseline, 45 days and 90 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (15)
- BACKGROUNDParnell JA, Raman M, Rioux KP, Reimer RA. The potential role of prebiotic fibre for treatment and management of non-alcoholic fatty liver disease and associated obesity and insulin resistance. Liver Int. 2012 May;32(5):701-11. doi: 10.1111/j.1478-3231.2011.02730.x. Epub 2011 Dec 30. PMID 22221818
- BACKGROUNDByrne CD, Olufadi R, Bruce KD, Cagampang FR, Ahmed MH. Metabolic disturbances in non-alcoholic fatty liver disease. Clin Sci (Lond). 2009 Apr;116(7):539-64. doi: 10.1042/CS20080253. PMID 19243311
- BACKGROUNDBrowning JD, Szczepaniak LS, Dobbins R, Nuremberg P, Horton JD, Cohen JC, Grundy SM, Hobbs HH. Prevalence of hepatic steatosis in an urban population in the United States: impact of ethnicity. Hepatology. 2004 Dec;40(6):1387-95. doi: 10.1002/hep.20466. PMID 15565570
- BACKGROUNDPreiss D, Sattar N. Non-alcoholic fatty liver disease: an overview of prevalence, diagnosis, pathogenesis and treatment considerations. Clin Sci (Lond). 2008 Sep;115(5):141-50. doi: 10.1042/CS20070402. PMID 18662168
- BACKGROUNDNeuschwander-Tetri BA, Caldwell SH. Nonalcoholic steatohepatitis: summary of an AASLD Single Topic Conference. Hepatology. 2003 May;37(5):1202-19. doi: 10.1053/jhep.2003.50193. PMID 12717402
- BACKGROUNDDowman JK, Armstrong MJ, Tomlinson JW, Newsome PN. Current therapeutic strategies in non-alcoholic fatty liver disease. Diabetes Obes Metab. 2011 Aug;13(8):692-702. doi: 10.1111/j.1463-1326.2011.01403.x. PMID 21449949
- BACKGROUNDPatel AA, Torres DM, Harrison SA. Effect of weight loss on nonalcoholic fatty liver disease. J Clin Gastroenterol. 2009 Nov-Dec;43(10):970-4. doi: 10.1097/MCG.0b013e3181b57475. PMID 19727004
- Musso G, Gambino R, Cassader M, Pagano G. A meta-analysis of randomized trials for the treatment of nonalcoholic fatty liver disease. Hepatology. 2010 Jul;52(1):79-104. doi: 10.1002/hep.23623.