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)

Sponsors

Lead Sponsor: University of Miami

Collaborator: Daiwa Health Development

Source University of Miami
Brief 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.

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:

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.

Overall Status Completed
Start Date May 2016
Completion Date June 10, 2017
Primary Completion Date June 10, 2017
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change from baseline in liver function test Baseline, 45 days and 90 days
Change from baseline in metabolic markers Baseline,45 days and 90 days
Change from baseline in immunological markers Baseline,45 days and, 3 months
Secondary Outcome
Measure Time Frame
Change from baseline in systolic blood pressure Baseline,45 days and 3 months
Change from baseline in Diastolic blood pressure 45 days and 90 days
Pulse Baseline,45 days and 3 months
Change from Baseline in Quality of Life Baseline,45 days and 3 months
Enrollment 23
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: rice bran arabinoxylan compound (RBAC)

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

Arm Group Label: Rice bran arabinoxylan compound (RBAC)

Intervention Type: Dietary Supplement

Intervention Name: Placebo

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

Arm Group Label: Placebo

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

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
John E Lewis, Ph.D. Principal Investigator University of Miami
Location
Facility: University of Miami Miller School of Medicine, Soffer Clinical Research Center, Department of Psychiatry & Behavioral Sciences
Location Countries

United States

Verification Date

June 2017

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Miami

Investigator Full Name: John E. Lewis

Investigator Title: Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Rice bran arabinoxylan compound (RBAC)

Type: Experimental

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

Label: Placebo

Type: Placebo Comparator

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

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Basic Science

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov