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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

Tracking Information
First Submitted Date  ICMJE August 1, 2014
First Posted Date  ICMJE August 12, 2014
Last Update Posted Date July 18, 2016
Study Start Date  ICMJE January 2015
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of an Enhanced Rice Bran Nutritional Supplement in HIV
Official Title  ICMJE The Effect of an Enhanced Rice Bran Nutritional Supplement on Metabolic Syndrome Variables in HIV
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.
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 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. Given that these micronutrients may be important for regulating the immune system and metabolizing glucose, the investigators will explore the impact of RBAC on metabolic syndrome (MetSyn) variables according to the National Cholesterol Education Program (NCEP) Adult Treatment Panel III guidelines (1) (fasting plasma glucose, waist circumference, high-density lipoprotein [HDL] cholesterol, triglycerides, and blood pressure), secondarily on additional atherogenic variables (total cholesterol, low-density lipoprotein [LDL] cholesterol, hip circumference, and body mass index) and immune functioning (CD4+ and CD8+) among 40 HIV+ adult (18+ years of age and over) patients on stable antiretroviral therapy (ART). Specifically, subjects will participate in a 6-month, two-group, randomized intervention, where one group (n=20) will take 3 gram/day RBAC and the other group (n=20) will take a placebo to compare differences in outcomes between the two groups. The results of the study are intended to address the multi-faceted physiological problems of HIV+ patients by testing the efficacy of a nutritional supplement intervention on multiple outcomes in this population.

No substantial psychological, medical, or social risks exist to the participants, other than minor discomfort associated with the venipuncture. Although all measures to protect confidentiality will be put in place, the possibility exists that electronic data could be jeopardized. In the remote case that such event occurs, it will be immediately reported to the Institutional Review Board.

The components of RBAC should be harmless without significant food allergies. No serious, untoward side effects have been reported to the company by consumers nor observed during previous human studies. Potential adverse effects will be explained to each participant when informed consent is obtained. Whole foods supplements are virtually no different than consuming food, because of how they are manufactured. The investigators prior study on RBAC showed no adverse effects. If any side effect does occur, the remedy is to discontinue until asymptomatic, and then reintroduce at 1/4 dosage, increasing by the same amount every 2 days, if uneventful, until full dosage is achieved. Study staff will provide additional follow-up and consultation with any subject who experiences an untoward side effect.

Other potential risks include:

  1. Randomization. A potential risk for the placebo group is no improvement in the investigators outcomes of interest.
  2. Data collection. The investigators foresee minimal risks associated with the testing, other than discomfort or fatigue.

A toxicology search for each component reveals no unique toxicity characteristic of the materials. As reported by Daiwa Health Development, the manufacturer of the product, thousands of people currently use RBAC (under the trade names BRM4 and PeakImmune 4), and Daiwa is unaware of significant toxicities. Daiwa applies the latest scientific methods to ensure the value and safety of their raw materials. Daiwa products are manufactured in state-of-the-art facilities, under strict quality control and environmental protection standards.

Participants will incur no additional appreciable psychological or social risks by participating in this study, although they may undergo psychological and physical discomfort sometimes. The process of interviewing during the assessment may cause discomfort. Discomfort or fatigue may also be experienced in completing the assessment battery.

Alternatives to this study for these MetSyn and immune functioning variables include prescription medications, exercise, dietary modification, and other nutritional supplements. The risks of medications can be very significant, including life-threatening, but the risk of taking nutritional supplements is not totally understood, since they are not regulated by the US Food and Drug Administration. Medications and nutritional supplements, as part of a change in lifestyle behaviors, may also prove to be beneficial for MetSyn variables and immune system functioning, but their long-term use has unknown consequences.

The information obtained in this study will help in determining the efficacy of using RBAC on MetSyn and metabolic variables and immune system functioning. By participating in the study, subjects may experience improved health status. The risk of participating in this study is reasonable because of the potential enhancements in metabolic and immune system functioning with improved nutritional status.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Human Immunodeficiency Virus Infection
Intervention  ICMJE
  • 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.
  • Dietary Supplement: Placebo
    2 capsules with 6 to 8 ounces of water 3 times per day (6 tablets total per day) for 6 months.
Study Arms  ICMJE
  • 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.
    Intervention: Dietary Supplement: rice bran arabinoxylan compound (RBAC)
  • Placebo Comparator: placebo
    2 capsules with 6 to 8 ounces of water 3 times per day (6 tablets total per day) for 6 months.
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 15, 2016)
47
Original Estimated Enrollment  ICMJE
 (submitted: August 7, 2014)
40
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02214173
Other Study ID Numbers  ICMJE 20130279
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party John E. Lewis, University of Miami
Study Sponsor  ICMJE University of Miami
Collaborators  ICMJE Daiwa Health Development
Investigators  ICMJE
Principal Investigator: John E Lewis, Ph.D. University of Miami
PRS Account University of Miami
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP