The Effect of an RBAC Supplement (BRM4) on NAFLD

Completed · Not applicable · Has a placebo group

Conditions studied: Non-Alcoholic Fatty Liver Disease

In brief

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.

Key facts

Study ID

NCT02568787

Run by

University of Miami

People needed

23

Starts

2016-05-01

Expected to finish

2017-06-10

Last updated by the study team

2017-06-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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
• Any implanted electronic device

Where it is running

• University of Miami Miller School of Medicine, Soffer Clinical Research Center, Department of Psychiatry & Behavioral Sciences — Miami, Florida, United States

Full record on ClinicalTrials.gov

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