NCT02568787

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 6, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2017

Completed
Last Updated

June 14, 2017

Status Verified

June 1, 2017

Enrollment Period

1.1 years

First QC Date

October 1, 2015

Last Update Submit

June 10, 2017

Conditions

Non-Alcoholic Fatty Liver Disease

Keywords

NAFLDcytokinesinterleukin (IL)interferon (IFN)liver function test (LFTS)nutritionbran arabinoxylan compound (RBAC)tumor necrosis factor -- type I receptor (TNF-RI)TNF-RII (tumor necrosis factor -- type II receptor (TNF-RII)

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • 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

Study Arms (2)

Rice bran arabinoxylan compound (RBAC)

EXPERIMENTAL

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

Dietary Supplement: rice bran arabinoxylan compound (RBAC)

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

rice bran arabinoxylan compound (RBAC)DIETARY_SUPPLEMENT

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

Rice bran arabinoxylan compound (RBAC)
PlaceboDIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami Miller School of Medicine, Soffer Clinical Research Center, Department of Psychiatry & Behavioral Sciences

Miami, Florida, 33136-2107, United States

Location

Related Publications (15)

  • Parnell JA, Raman M, Rioux KP, Reimer RA. The potential role of prebiotic fibre for treatment and management of non-alcoholic fatty liver disease and associated obesity and insulin resistance. Liver Int. 2012 May;32(5):701-11. doi: 10.1111/j.1478-3231.2011.02730.x. Epub 2011 Dec 30.

    PMID: 22221818BACKGROUND

  • Byrne CD, Olufadi R, Bruce KD, Cagampang FR, Ahmed MH. Metabolic disturbances in non-alcoholic fatty liver disease. Clin Sci (Lond). 2009 Apr;116(7):539-64. doi: 10.1042/CS20080253.

    PMID: 19243311BACKGROUND

  • Browning JD, Szczepaniak LS, Dobbins R, Nuremberg P, Horton JD, Cohen JC, Grundy SM, Hobbs HH. Prevalence of hepatic steatosis in an urban population in the United States: impact of ethnicity. Hepatology. 2004 Dec;40(6):1387-95. doi: 10.1002/hep.20466.

    PMID: 15565570BACKGROUND

  • Preiss D, Sattar N. Non-alcoholic fatty liver disease: an overview of prevalence, diagnosis, pathogenesis and treatment considerations. Clin Sci (Lond). 2008 Sep;115(5):141-50. doi: 10.1042/CS20070402.

    PMID: 18662168BACKGROUND

  • Neuschwander-Tetri BA, Caldwell SH. Nonalcoholic steatohepatitis: summary of an AASLD Single Topic Conference. Hepatology. 2003 May;37(5):1202-19. doi: 10.1053/jhep.2003.50193.

    PMID: 12717402BACKGROUND

  • Dowman JK, Armstrong MJ, Tomlinson JW, Newsome PN. Current therapeutic strategies in non-alcoholic fatty liver disease. Diabetes Obes Metab. 2011 Aug;13(8):692-702. doi: 10.1111/j.1463-1326.2011.01403.x.

    PMID: 21449949BACKGROUND

  • Patel AA, Torres DM, Harrison SA. Effect of weight loss on nonalcoholic fatty liver disease. J Clin Gastroenterol. 2009 Nov-Dec;43(10):970-4. doi: 10.1097/MCG.0b013e3181b57475.

    PMID: 19727004BACKGROUND

  • Musso G, Gambino R, Cassader M, Pagano G. A meta-analysis of randomized trials for the treatment of nonalcoholic fatty liver disease. Hepatology. 2010 Jul;52(1):79-104. doi: 10.1002/hep.23623.

    PMID: 20578268BACKGROUND

  • Zheng S, Sanada H, Dohi H, Hirai S, Egashira Y. Suppressive effect of modified arabinoxylan from rice bran (MGN-3) on D-galactosamine-induced IL-18 expression and hepatitis in rats. Biosci Biotechnol Biochem. 2012;76(5):942-6. doi: 10.1271/bbb.110968. Epub 2012 May 7.

    PMID: 22738964BACKGROUND

  • Zheng S, Sugita S, Hirai S, Egashira Y. Protective effect of low molecular fraction of MGN-3, a modified arabinoxylan from rice bran, on acute liver injury by inhibition of NF-kappaB and JNK/MAPK expression. Int Immunopharmacol. 2012 Dec;14(4):764-9. doi: 10.1016/j.intimp.2012.10.012. Epub 2012 Oct 29.

    PMID: 23116638BACKGROUND

  • 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.

    BACKGROUND

  • Ghoneum M, Matsuura M. Augmentation of macrophage phagocytosis by modified arabinoxylan rice bran (MGN-3/biobran). Int J Immunopathol Pharmacol. 2004 Sep-Dec;17(3):283-92. doi: 10.1177/039463200401700308.

    PMID: 15461862BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

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

    BACKGROUND

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Study Officials

  • John E Lewis, Ph.D.

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 1, 2015

First Posted

October 6, 2015

Study Start

May 1, 2016

Primary Completion

June 10, 2017

Study Completion

June 10, 2017

Last Updated

June 14, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)