Human Immunodeficiency Virus Infection Clinical Trial
— BRM4Official title:
The Effect of an Enhanced Rice Bran Nutritional Supplement on Metabolic Syndrome Variables in HIV
Verified date | July 2016 |
Source | University of Miami |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 47 |
Est. completion date | June 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Age 18 or older 2. Confirmed HIV infection 3. CD4 T cell counts > 50/µl and < 250/µl 4. On a stable ART regimen (e.g., Kaletra-based) before (=6 months) and during the intervention 5. Planning to maintain current medication during the course of the intervention 6. Not on any lipid-lowering agents for a minimum of 3 months before the enrollment 7. Previous nutritional supplement usage of similar polysaccharide formula permitted, but current use must be stopped 2 weeks before and during trial 8. Interested in participating in a dietary supplement study 9. Willing to follow recommendations for participating in the study 10. Willing to not consume food, alcohol, caffeine, or stimulants (amphetamines) 12 hours before each assessment 11. 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 resorption of the study supplement 4. Other medical complications that might preclude one from participating in the study, i.e., recent heart attack or stroke or chronic kidney disease 5. Currently taking immunomodulatory medication, i.e., interferon 6. Currently taking chemotherapeutic agents 7. Multiple drug resistance 8. Current smoker 9. Severe anemia or other medical condition that will not permit a safe blood draw 10. A bleeding disorder 11. A terminal illness 12. Women who are pregnant or are attempting conception, especially in the presence of a history of recurrent spontaneous abortion |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United States | University of Miami Miller School of Medicine, Clinical Research Building, Department of Psychiatry & Behavioral Sciences | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Miami | Daiwa Health Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improvement in Metabolic Syndrome Markers | Improvement in glucose, lipid profile, blood pressure, cluster of differentiation 4 (CD4), and cluster of differentiation 8 (CD8) values. | 3 months and 6 months | No |
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