Clinical trial NCT02568787: The Effect of an RBAC Supplement (BRM4) on NAFLD
Official title: The Effect of an Enhanced Rice Bran Nutritional Supplement on Non-Alcoholic Fatty Liver Disease (NAFLD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease
Keywords: 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)
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Daiwa Health Development
First posted: 2015-10-06
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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

Primary outcomes:
measure: Change from baseline in liver function test
timeFrame: Baseline, 45 days and 90 days
measure: Change from baseline in metabolic markers
timeFrame: Baseline,45 days and 90 days
measure: Change from baseline in immunological markers
timeFrame: Baseline,45 days and, 3 months
Secondary outcomes:
measure: Change from baseline in systolic blood pressure
timeFrame: Baseline,45 days and 3 months
measure: Change from baseline in Diastolic blood pressure
timeFrame: 45 days and 90 days
measure: Pulse
timeFrame: Baseline,45 days and 3 months
measure: Change from Baseline in Quality of Life
timeFrame: Baseline,45 days and 3 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Miller School of Medicine, Soffer Clinical Research Center, Department of Psychiatry & Behavioral Sciences
state: Florida
Study officials:
affiliation: University of Miami
name: John E Lewis, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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