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The Effect of an RBAC Supplement (BRM4) on NAFLD

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02568787
First Posted: October 6, 2015
Last Update Posted: June 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Daiwa Health Development
Information provided by (Responsible Party):
John E. Lewis, University of Miami
  Purpose
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.

Condition Intervention
Non-Alcoholic Fatty Liver Disease Dietary Supplement: rice bran arabinoxylan compound (RBAC) Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effect of an Enhanced Rice Bran Nutritional Supplement on Non-Alcoholic Fatty Liver Disease (NAFLD)

Resource links provided by NLM:


Further study details as provided by John E. Lewis, University of Miami:

Primary Outcome Measures:
  • 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

  • Change from baseline in metabolic markers [ Time Frame: Baseline,45 days and 90 days ]
    Metabolic markers as defined by lipid profile

  • 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.


Secondary Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.


Enrollment: 23
Actual Study Start Date: May 2016
Study Completion Date: June 10, 2017
Primary Completion Date: June 10, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02568787


Locations
United States, Florida
University of Miami Miller School of Medicine, Soffer Clinical Research Center, Department of Psychiatry & Behavioral Sciences
Miami, Florida, United States, 33136-2107
Sponsors and Collaborators
University of Miami
Daiwa Health Development
Investigators
Principal Investigator: John E Lewis, Ph.D. University of Miami
  More Information

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

Responsible Party: John E. Lewis, Principal Investigator, University of Miami
ClinicalTrials.gov Identifier: NCT02568787     History of Changes
Other Study ID Numbers: 20150512
First Submitted: October 1, 2015
First Posted: October 6, 2015
Last Update Posted: June 14, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by John E. Lewis, University of Miami:
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)

Additional relevant MeSH terms:
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases