Skip to main content
OpenTrials
Completed

NCT Number: NCT02568787

The Effect of an RBAC Supplement (BRM4) on 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Non-Alcoholic Fatty Liver Disease Digestive System Diseases Fatty Liver Liver Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Miami, Florida, 33136-2107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rice bran arabinoxylan compound (RBAC)

Dietary Supplement

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

Placebo

Dietary Supplement

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

Primary outcomes

  1. 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

  2. Change from baseline in metabolic markers

    Time frame: Baseline,45 days and 90 days

    Metabolic markers as defined by lipid profile

  3. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Daiwa Health Development

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 6, 2015
Registry last updated
Jun 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.