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The Effect of an Enhanced Rice Bran Nutritional Supplement in HIV (BRM4)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02214173
Recruitment Status : Completed
First Posted : August 12, 2014
Last Update Posted : July 18, 2016
Sponsor:
Collaborator:
Daiwa Health Development
Information provided by (Responsible Party):
John E. Lewis, University of Miami

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 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.

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus Infection Dietary Supplement: rice bran arabinoxylan compound (RBAC) Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effect of an Enhanced Rice Bran Nutritional Supplement on Metabolic Syndrome Variables in HIV
Study Start Date : January 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: rice bran arabinoxylan compound (RBAC)
2 capsules with 6 to 8 ounces of water 3 times per day (6 tablets total per day) for 6 months.
Dietary Supplement: rice bran arabinoxylan compound (RBAC)
2 capsules with 6 to 8 ounces of water 3 times per day (6 tablets total per day) for 6 months.

Placebo Comparator: placebo
2 capsules with 6 to 8 ounces of water 3 times per day (6 tablets total per day) for 6 months.
Dietary Supplement: Placebo
2 capsules with 6 to 8 ounces of water 3 times per day (6 tablets total per day) for 6 months.




Primary Outcome Measures :
  1. Improvement in Metabolic Syndrome Markers [ Time Frame: 3 months and 6 months ]
    Improvement in glucose, lipid profile, blood pressure, cluster of differentiation 4 (CD4), and cluster of differentiation 8 (CD8) values.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02214173


Locations
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United States, Florida
University of Miami Miller School of Medicine, Clinical Research Building, Department of Psychiatry & Behavioral Sciences
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Daiwa Health Development
Investigators
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Principal Investigator: John E Lewis, Ph.D. University of Miami
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Responsible Party: John E. Lewis, Principal Investigator, University of Miami
ClinicalTrials.gov Identifier: NCT02214173    
Other Study ID Numbers: 20130279
First Posted: August 12, 2014    Key Record Dates
Last Update Posted: July 18, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by John E. Lewis, University of Miami:
HIV, BRM4, hydrolyzed rice bran, metabolic syndrome
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Virus Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases