The Effect of an Enhanced Rice Bran Nutritional Supplement on Non-Alcoholic Fatty Liver Disease (NAFLD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Change from baseline in liver function test
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change from baseline in liver function test
时间窗: Baseline, 45 days and 90 days
Liver function tests as defined by serum ALT, AST and ALP
Change from baseline in immunological markers
时间窗: 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.
Change from baseline in metabolic markers
时间窗: Baseline,45 days and 90 days
Metabolic markers as defined by lipid profile
次要结局
- 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)
研究者
John E. Lewis
Principal Investigator
University of Miami