Non-Alcoholic Fatty Liver Disease
Conditions
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)
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.
Interventions
DIETARY_SUPPLEMENTrice bran arabinoxylan compound (RBAC)
Take 2 tablets 1 time (1 gram) per day for the 3-month intervention period.
DIETARY_SUPPLEMENTPlacebo
Take 2 tablets 1 time (1 gram) per day for the 3-month intervention period.
Sponsors
Daiwa Health Development
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in liver function test | Baseline, 45 days and 90 days | Liver function tests as defined by serum ALT, AST and ALP |
| Change from baseline in metabolic markers | Baseline,45 days and 90 days | Metabolic markers as defined by lipid profile |
| Change from baseline in immunological markers | 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
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in systolic blood pressure | 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 Quality of Life | 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. |
| Change from baseline in Diastolic blood pressure | 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 | 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. |
Countries
United States
Outcome results
None listed