Back to results

The Effect of an RBAC Supplement (BRM4) on NAFLD

Primary Purpose

Non-Alcoholic Fatty Liver Disease

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

rice bran arabinoxylan compound (RBAC)

Placebo

About this trial

This is an interventional basic science trial for Non-Alcoholic Fatty Liver Disease focused on measuring NAFLD, cytokines, interleukin (IL), interferon (IFN), liver function test (LFTS), nutrition, bran arabinoxylan compound (RBAC), tumor necrosis factor -- type I receptor (TNF-RI), TNF-RII (tumor necrosis factor -- type II receptor (TNF-RII)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Age 18 or older
Confirmed NAFLD diagnosis
On a stable medication regimen during the intervention
Planning to maintain current medication during the course of the intervention
Willing to have blood drawn
Previous nutritional supplement usage of similar polysaccharide formula permitted, but current use must be stopped 2 weeks before and during trial
Interested in participating in a dietary supplement study
Willing to follow recommendations for participating in the study
Willing to not consume food, alcohol, caffeine, or stimulants (amphetamines) 12 hours before each assessment
Able to provide informed consent

Exclusion Criteria:

Currently enrolled in another research trial for similar investigative nutritional therapies
Known allergy to rice, rice bran, mushrooms, or related food products
Any gastrointestinal disorders that could lead to uncertain absorption of the study supplement
Taking any lipid-lowering agent for the prior 3 months before study enrollment
Currently taking immunomodulatory medication, i.e., interferon
Currently taking chemotherapeutic agents
Severe anemia or other medical condition that will not permit a safe blood draw
A bleeding disorder
A terminal illness
Women who are pregnant or are attempting conception, especially in the presence of a history of recurrent spontaneous abortion
Currently undergoing internal defibrillation, like with an implantable heart device
Erratic, accelerated, or mechanically controlled irregular heart rhythms
Atrial fibrillation/flutter
Atrioventricular block
Recently had dyes introduced into the bloodstream, such as methylene blue, indocyanine green, indigo carmine, and fluorescein
Any implanted electronic device

Sites / Locations

University of Miami Miller School of Medicine, Soffer Clinical Research Center, Department of Psychiatry & Behavioral Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Rice bran arabinoxylan compound (RBAC)

Placebo

Arm Description

Take 2 tablets 1 time (1 gram) per day for the 3-month intervention period.

Outcomes

Primary Outcome Measures

Change from baseline in liver function test

Liver function tests as defined by serum ALT, AST and ALP

Change from baseline in metabolic markers

Metabolic markers as defined by lipid profile

Change from baseline in immunological markers

Immunological markers as defined by TNF-α, LT-α, IL-1α, IL-1β, IL-6, TNF RI, IFN-γ, 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.

Secondary Outcome Measures

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.

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.

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.

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.

Full Information

NCT ID

NCT02568787

First Posted

October 1, 2015

Last Updated

June 10, 2017

Sponsor

University of Miami

Collaborators

Daiwa Health Development

1. Study Identification

Unique Protocol Identification Number

NCT02568787

Brief Title

The Effect of an RBAC Supplement (BRM4) on NAFLD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

May 2016 (Actual)

Primary Completion Date

June 10, 2017 (Actual)

Study Completion Date

June 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Miami

Collaborators

Daiwa Health Development

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Detailed 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: albumin 4-hydroxynonenal lipids liver enzymes (alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) malondialdehyde γ-glutamyltransferase 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) lymphocytes 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-Alcoholic Fatty Liver Disease

Keywords

NAFLD, cytokines, interleukin (IL), interferon (IFN), liver function test (LFTS), nutrition, bran arabinoxylan compound (RBAC), tumor necrosis factor -- type I receptor (TNF-RI), TNF-RII (tumor necrosis factor -- type II receptor (TNF-RII)

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Rice bran arabinoxylan compound (RBAC)

Arm Type

Experimental

Arm Description

Take 2 tablets 1 time (1 gram) per day for the 3-month intervention period.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Take 2 tablets 1 time (1 gram) per day for the 3-month intervention period.

Intervention Type

Dietary Supplement

Intervention Name(s)

rice bran arabinoxylan compound (RBAC)

Intervention Description

Take 2 tablets 1 time (1 gram) per day for the 3-month intervention period.

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

Take 2 tablets 1 time (1 gram) per day for the 3-month intervention period.

Primary Outcome Measure Information:

Title

Change from baseline in liver function test

Description

Liver function tests as defined by serum ALT, AST and ALP

Time Frame

Baseline, 45 days and 90 days

Title

Change from baseline in metabolic markers

Description

Metabolic markers as defined by lipid profile

Time Frame

Baseline,45 days and 90 days

Title

Change from baseline in immunological markers

Description

Immunological markers as defined by TNF-α, LT-α, IL-1α, IL-1β, IL-6, TNF RI, IFN-γ, 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.

Time Frame

Baseline,45 days and, 3 months

Secondary Outcome Measure Information:

Title

Change from baseline in systolic blood pressure

Description

Time Frame

Baseline,45 days and 3 months

Title

Change from baseline in Diastolic blood pressure

Description

Time Frame

45 days and 90 days

Title

Pulse

Description

Time Frame

Baseline,45 days and 3 months

Title

Change from Baseline in Quality of Life

Description

Time Frame

Baseline,45 days and 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18 or older Confirmed NAFLD diagnosis On a stable medication regimen during the intervention Planning to maintain current medication during the course of the intervention Willing to have blood drawn Previous nutritional supplement usage of similar polysaccharide formula permitted, but current use must be stopped 2 weeks before and during trial Interested in participating in a dietary supplement study Willing to follow recommendations for participating in the study Willing to not consume food, alcohol, caffeine, or stimulants (amphetamines) 12 hours before each assessment Able to provide informed consent Exclusion Criteria: Currently enrolled in another research trial for similar investigative nutritional therapies Known allergy to rice, rice bran, mushrooms, or related food products Any gastrointestinal disorders that could lead to uncertain absorption of the study supplement Taking any lipid-lowering agent for the prior 3 months before study enrollment Currently taking immunomodulatory medication, i.e., interferon Currently taking chemotherapeutic agents Severe anemia or other medical condition that will not permit a safe blood draw A bleeding disorder A terminal illness Women who are pregnant or are attempting conception, especially in the presence of a history of recurrent spontaneous abortion Currently undergoing internal defibrillation, like with an implantable heart device Erratic, accelerated, or mechanically controlled irregular heart rhythms Atrial fibrillation/flutter Atrioventricular block Recently had dyes introduced into the bloodstream, such as methylene blue, indocyanine green, indigo carmine, and fluorescein Any implanted electronic device

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John E Lewis, Ph.D.

Organizational Affiliation

University of Miami

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Miami Miller School of Medicine, Soffer Clinical Research Center, Department of Psychiatry & Behavioral Sciences

City

Miami

State/Province

Florida

ZIP/Postal Code

33136-2107

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

22221818

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.

Results Reference

background

PubMed Identifier

19243311

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.

Results Reference

background

PubMed Identifier

15565570

Citation

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. doi: 10.1002/hep.20466.

Results Reference

background

PubMed Identifier

18662168

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.

Results Reference

background

PubMed Identifier

12717402

Citation

Neuschwander-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. Erratum In: Hepatology. 2003 Aug;38(2):536.

Results Reference

background

PubMed Identifier

21449949

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.

Results Reference

background

PubMed Identifier

19727004

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.

Results Reference

background

PubMed Identifier

20578268

Citation

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.

Results Reference

background

PubMed Identifier

22738964

Citation

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. doi: 10.1271/bbb.110968. Epub 2012 May 7.

Results Reference

background

PubMed Identifier

23116638

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-kappaB and JNK/MAPK expression. Int Immunopharmacol. 2012 Dec;14(4):764-9. doi: 10.1016/j.intimp.2012.10.012. Epub 2012 Oct 29.

Results Reference

background

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.

Results Reference

background

PubMed Identifier

15461862

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. doi: 10.1177/039463200401700308.

Results Reference

background

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.

Results Reference

background

Citation

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.

Results Reference

background

Citation

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

Results Reference

background

Learn more about this trial

The Effect of an RBAC Supplement (BRM4) on NAFLD

We'll reach out to this number within 24 hrs