The Effect of an RBAC Supplement (BRM4) on NAFLD

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Non-Alcoholic Fatty Liver Disease

Intervention / Treatment
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* Dietary Supplement: rice bran arabinoxylan compound (RBAC)
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rice bran arabinoxylan compound (RBAC)<br>Take 2 tablets 1 time (1 gram) per day for the 3-month intervention period. | Dietary Supplement: rice bran arabinoxylan compound (RBAC)<br>* Take 2 tablets 1 time (1 gram) per day for the 3-month intervention period.<br>|
| Placebo Comparator: Placebo<br>Take 2 tablets 1 time (1 gram) per day for the 3-month intervention period. | Dietary Supplement: Placebo<br>* Take 2 tablets 1 time (1 gram) per day for the 3-month intervention period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in liver function test | Liver function tests as defined by serum ALT, AST and ALP | Baseline, 45 days and 90 days | 
| Change from baseline in metabolic markers | Metabolic markers as defined by lipid profile | Baseline,45 days and 90 days | 
| 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. | Baseline,45 days and, 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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)