The Effect of an RBAC Supplement (BRM4) on NAFLD

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02568787
• Other study ID #: 20150512
• Status: Completed
• Phase: N/A
• First received: October 1, 2015
• Last updated: June 10, 2017
• Start date: May 2016
• Est. completion date: June 10, 2017

Study information

• Verified date: June 2017
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: June 10, 2017
• Est. primary completion date: June 10, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-Alcoholic Fatty Liver Disease

Intervention

Dietary Supplement:
• rice bran arabinoxylan compound (RBAC)
Take 2 tablets 1 time (1 gram) per day for the 3-month intervention period.
• Placebo
Take 2 tablets 1 time (1 gram) per day for the 3-month intervention period.

Locations

Country	Name	City	State
United States	University of Miami Miller School of Medicine, Soffer Clinical Research Center, Department of Psychiatry & Behavioral Sciences	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Daiwa Health Development

Country where clinical trial is conducted

United States, 

References & Publications (15)

Ali K, Melillo A, Leonard S, Asthana D, Woolger J, Wolfson A, et al. An open-label, randomized clinical trial to assess the immunomodulatory activity of a novel oligosaccharide compound in healthy adults. Functional Foods in Health and Disease 2012;2(7):265-79.

Browning 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. — View Citation

Byrne 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. Review. — View Citation

Dowman 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. Review. — View Citation

Ghoneum M, Matsuura M. Augmentation of macrophage phagocytosis by modified arabinoxylan rice bran (MGN-3/biobran). Int J Immunopathol Pharmacol. 2004 Sep-Dec;17(3):283-92. — View Citation

Ghoneum M. Enhancement of human natural killer cell activity by modified Arabinoxylan from rice bran (MGN-3). Int J Immunotherapy 1998;14(2):89-99.

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. — View Citation

Neuschwander-Tetri BA, Caldwell SH. Nonalcoholic steatohepatitis: summary of an AASLD Single Topic Conference. Hepatology. 2003 May;37(5):1202-19. Review. Erratum in: Hepatology. 2003 Aug;38(2):536. — View Citation

Parnell 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. Review. — View Citation

Patel 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. Review. — View Citation

Preiss 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. Review. — View Citation

Tazawa K, Namikawa H, Oida N, Masada M, Maeda H. Scavenging activity of modified arabinoxylane from rice bran (biobran/mgn-3) with natural killer cell activity on free radicals. Biotherapy 2000;14:493-5.

Ware J, Kosinski M, Dewey J. How to score version two of the SF-36 health survey. Lincoln, RI: QualityMetric, Incorporated; 2000. ISBN 1891810057

Zheng S, Sanada H, Dohi H, Hirai S, Egashira Y. Suppressive effect of modified arabinoxylan from rice bran (MGN-3) on D-galactosamine-induced IL-18 expression and hepatitis in rats. Biosci Biotechnol Biochem. 2012;76(5):942-6. Epub 2012 May 7. — View Citation

Zheng S, Sugita S, Hirai S, Egashira Y. Protective effect of low molecular fraction of MGN-3, a modified arabinoxylan from rice bran, on acute liver injury by inhibition of NF-?B and JNK/MAPK expression. Int Immunopharmacol. 2012 Dec;14(4):764-9. doi: 10.1016/j.intimp.2012.10.012. Epub 2012 Oct 29. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in liver function test	Liver function tests as defined by serum ALT, AST and ALP	Baseline, 45 days and 90 days
Primary	Change from baseline in metabolic markers	Metabolic markers as defined by lipid profile	Baseline,45 days and 90 days
Primary	Change from baseline in immunological markers	Immunological markers as defined by TNF-a, LT-a, IL-1a, IL-1ß, IL-6, TNF RI, IFN-?, IL-12, IL-2, IL-15, IL-8, TNF RII, IL-4, IL-5, IL-17, IL-23, IL-10, IL-13, and IL-18.	Baseline,45 days and, 3 months
Secondary	Change from baseline in systolic blood pressure	Systolic blood pressure will be measured to the nearest even digit by use of the Microlife Deluxe upper arm blood pressure monitor. Three readings will be made with the subjects seated after they have rested for five minutes. The average of the three readings will be used in the analysis.	Baseline,45 days and 3 months
Secondary	Change from baseline in Diastolic blood pressure	Diastolic blood pressure will be measured to the nearest even digit by use of the Microlife Deluxe upper arm blood pressure monitor. Three readings will be made with the subjects seated after they have rested for five minutes. The average of the three readings will be used in the analysis.	45 days and 90 days
Secondary	Pulse	Pulse will be measured to the nearest even digit by use of the Microlife Deluxe upper arm blood pressure monitor. Three readings will be made with the subjects seated after they have rested for five minutes. The average of the three readings will be used in the analysis.	Baseline,45 days and 3 months
Secondary	Change from Baseline in Quality of Life	The SF-36v2™ Health Survey (15) provides psychometrically-based physical and mental health summary measures and a preference-based health utility index. It is a generic measure that does not target a specific age, disease, or treatment group.	Baseline,45 days and 3 months