The Effect of an RBAC Supplement (BRM4) on NAFLD

June 10, 2017 updated by: John E. Lewis, University of Miami

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136-2107
        • University of Miami Miller School of Medicine, Soffer Clinical Research Center, Department of Psychiatry & Behavioral Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in systolic blood pressure
Time Frame: 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.
Baseline,45 days and 3 months
Change from baseline in Diastolic blood pressure
Time Frame: 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.
45 days and 90 days
Pulse
Time Frame: 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.
Baseline,45 days and 3 months
Change from Baseline in Quality of Life
Time Frame: 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.
Baseline,45 days and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

Daiwa Health Development

Investigators

  • Principal Investigator: John E Lewis, Ph.D., University of Miami

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

June 10, 2017

Study Completion (Actual)

June 10, 2017

Study Registration Dates

First Submitted

October 1, 2015

First Submitted That Met QC Criteria

October 5, 2015

First Posted (Estimate)

October 6, 2015

Study Record Updates

Last Update Posted (Actual)

June 14, 2017

Last Update Submitted That Met QC Criteria

June 10, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20150512

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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