The Effect of an Enhanced Rice Bran Nutritional Supplement in HIV

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.

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