The Effect of an RBAC Supplement (BRM4) on NAFLD

Not Applicable

Completed

• Conditions: Non-Alcoholic Fatty Liver Disease
• Interventions: Dietary Supplement: rice bran arabinoxylan compound (RBAC); Dietary Supplement: Placebo

• Registration Number: NCT02568787
• Lead Sponsor: 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-10-01
• Study First Submitted QC: 2015-10-05
• Study First Posted: 2015-10-06
• Study Start: 2016-05
• Status Verified: 2017-06
• Primary Completion: 2017-06-10
• Study Completion: 2017-06-10
• Last Update Submitted: 2017-06-10
• Last Update Posted: 2017-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rice bran arabinoxylan compound (RBAC)	rice bran arabinoxylan compound (RBAC)	Take 2 tablets 1 time (1 gram) per day for the 3-month intervention period.
Placebo	Placebo	Take 2 tablets 1 time (1 gram) per day for the 3-month intervention period.

Primary Outcome Measures

Name	Time	Method
Change from baseline in liver function test	Baseline, 45 days and 90 days	Liver function tests as defined by serum ALT, AST and ALP
Change from baseline in immunological markers	Baseline,45 days and, 3 months	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.
Change from baseline in metabolic markers	Baseline,45 days and 90 days	Metabolic markers as defined by lipid profile

Secondary Outcome Measures

Name	Time	Method
Change from baseline in systolic blood pressure	Baseline,45 days and 3 months	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	45 days and 90 days	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	Baseline,45 days and 3 months	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	Baseline,45 days and 3 months	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.

Trial Locations

Locations (1)

University of Miami Miller School of Medicine, Soffer Clinical Research Center, Department of Psychiatry & Behavioral Sciences; 🇺🇸 Miami, Florida, United States