Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science


Related Conditions & MeSH terms


NCT number NCT02214173
Study type Interventional
Source University of Miami
Contact
Status Completed
Phase N/A
Start date January 2015
Completion date June 2016

See also
  Status Clinical Trial Phase
Not yet recruiting NCT05981807 - HPV Infection, Sexually Transmitted Infections and Anal Dysplasia in the Transgender Population
Completed NCT01490359 - Men Together Making a Difference: Reducing HIV/STD Risk Behavior Among South African Men N/A
Completed NCT03143205 - Gene Expression Outcomes in Interventions for Substance Using HIV+ Minority Men N/A
Completed NCT02738138 - A Study to Evaluate the Efficacy and Safety of Experimental Drugs ABT- 493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1-6 Infection and Human Immunodeficiency Virus -1 Coinfection (EXPEDITION-2) Phase 3
Completed NCT01791465 - Pilot Study of Bydureon to Treat Diabetes in HIV-infected Adults Phase 4
Completed NCT01869634 - Mechanisms of Immune Reconstitution & Reduced Immune Activation Following Darunavir-based ART Phase 4
Completed NCT01662336 - Real-life Effectiveness of the Kaletra Adherence Support Assistance (KASA) Program N/A
Completed NCT01383005 - Treatment Perception of QD (Once a Day) Dosed Kaletra (Tablets) N/A
Completed NCT01328158 - Drug Use Investigation of Kaletra Tablets (Once Daily Administration) on Patients With HIV-infection N/A
Completed NCT00711009 - Study Comparing Lopinavir/Ritonavir (LPV/r) + Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) With a Nucleoside Sparing Regimen Consisting of Lopinavir/Ritonavir + Raltegravir (RAL) Phase 3
Completed NCT02817451 - DTaP-IPV-HB-PRP-T Combined Vaccine as a Primary Series and a Second Year of Life Booster in HIV-Exposed Infected and Uninfected Infants Phase 3
Completed NCT03284645 - Viral and Antiretroviral Dynamics in HIV-1 Mother-to-Child Transmission Fluids
Terminated NCT01737359 - A Safety and Efficacy Study of Amdoxovir in HIV-1 Treatment-experienced Subjects. Phase 2
Active, not recruiting NCT05141422 - A Drug-drug Interaction Study of SHR2150 on Healthy Chinese Volunteers Phase 1
Completed NCT01939197 - A Multipart, Open-label Study to Evaluate the Safety and Efficacy of ABT-450/r/ABT-267 With and Without ABT-333 Coadministered With and Without Ribavirin in Adult With Genotype 1 or 4 Hepatitis C Virus (HCV) Infection and Human Immunodeficiency Virus, Type 1 Coinfection Phase 2/Phase 3
Completed NCT01447680 - Comparison of Plasma & SMARTplasma for Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV) Antibody Testing N/A
Not yet recruiting NCT05769413 - Awareness of Osteoporosis in HIV Patients
Withdrawn NCT01738555 - A Safety and Efficacy Study of Amdoxovir in HIV-1 Treatment-experienced Subjects Phase 2