The Effect of an Enhanced Rice Bran Nutritional Supplement in HIV

Completed · Not applicable · Has a placebo group

Conditions studied: Human Immunodeficiency Virus Infection

In brief

The purpose of this study is to investigate the effects of the nutritional supplement rice bran arabinoxylan compound (RBAC) on metabolic syndrome variables in persons living with HIV. The hypothesis is that there will be a significant improvement in metabolic syndrome and immune variables in HIV-positive participants in the intervention group compared to the control group.

Key facts

Study ID

NCT02214173

Run by

University of Miami

People needed

47

Starts

2015-01-01

Expected to finish

2016-06-01

Last updated by the study team

2016-07-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 or older
• Confirmed HIV infection
• CD4 T cell counts > 50/µl and < 250/µl
• On a stable ART regimen (e.g., Kaletra-based) before (≤6 months) and during the intervention
• Planning to maintain current medication during the course of the intervention
• Not on any lipid-lowering agents for a minimum of 3 months before the enrollment
• 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 resorption of the study supplement
• Other medical complications that might preclude one from participating in the study, i.e., recent heart attack or stroke or chronic kidney disease
• Currently taking immunomodulatory medication, i.e., interferon
• Currently taking chemotherapeutic agents
• Multiple drug resistance
• Current smoker
• 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

Where it is running

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

Full record on ClinicalTrials.gov

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