Status:
COMPLETED
The Effect of an Enhanced Rice Bran Nutritional Supplement in HIV
Lead Sponsor:
University of Miami
Collaborating Sponsors:
Daiwa Health Development
Conditions:
Human Immunodeficiency Virus Infection
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
The purpose of this study is to investigate the effects of Rice Bran Arabinoxylan Compound (RBAC) on metabolic syndrome variables in persons living with HIV (PLWH). This nutritional supplement is made...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT02214173
Start Date
January 1 2015
End Date
June 1 2016
Last Update
July 18 2016
Active Locations (1)
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1
University of Miami Miller School of Medicine, Clinical Research Building, Department of Psychiatry & Behavioral Sciences
Miami, Florida, United States, 33136