Abstract
The primary objective of the study was to evaluate the effects of a hydrolyzed polysaccharide, rice bran arabinoxylan compound (RBAC), on immune, hepatic, and renal function in HIV + individuals. A 6-month randomized double-blind placebo-controlled trial was utilized to conduct the intervention. Forty-seven HIV + individuals on stable antiretroviral therapy were enrolled and randomly assigned to one of the 2 study conditions (n = 22 RBAC and n = 25 placebo) and consumed 3 gram/day of either compound for 6 months. Participants were assessed at baseline and 3 and 6 months follow-up for CD4+ and CD8+, liver enzymes, and kidney function. No side effects were reported, and liver and kidney markers remained nearly completely within normal limits. The percentage change in CD4+ was similar for the placebo (+2.2%) and RBAC (+3.1%) groups at 6 months follow-up. The percentage change in CD8+ count significantly decreased from baseline to 6 months in the RBAC group (−5.2%), whereas it increased in the placebo group (+57.8%; p = 0.04). The CD4+/CD8+ ratio improved clinically in the RBAC group from 0.95 (SD = 0.62) at baseline to 1.07 (SD = 0.11) at 6 months, whereas it declined in the placebo group from 0.96 (SD = 0.80) at baseline to 0.72 (SD = 0.59) at 6 months. Our results showed a statistically significant decrease in CD8+ count and a clinically significant increase in CD4+/CD8+ ratio for the RBAC group compared to the placebo group. Thus, the results of this study suggest that the immunomodulatory and antisenescent activities of RBAC are promising for the HIV population.
Acknowledgments
We are thankful to all of the volunteers who participated in this study. Daiwa Health Development participated in the design of the protocol for the study.
Data availability statement
The data that support the findings of this study are available from the corresponding author (JEL) upon reasonable request.
Declaration of interest
John E. Lewis has been paid by Daiwa Pharmaceutical to speak at international conferences and write articles on health and wellness for their website. Steven E. Atlas, Muhammad H. Abbas, Ammar Rasul, Ashar Farooqi, Laura A. Lantigua, Lucas C. Lages, Frederick Michaud, Sharon Goldberg, Oscar L. Higuera, Andrea Fiallo, Eduard Tiozzo, Judi M. Woolger, Stephanie Ciraula, Armando Mendez, Allan Rodriguez, and Janet Konefal have no conflicts of interest.
About the authors
John E. Lewis, PhD, Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA. His research interests include the effects of nutrition and dietary supplementation on multiple outcomes in clinical trials.
Steven E. Atlas, BSN, Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA. His research interests include the effects of nutrition and dietary supplementation on multiple outcomes in clinical trials.
Muhammad H. Abbas, MD, Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA. His research interests include the effects of nutrition and dietary supplementation on multiple outcomes in clinical trials.
Ammar Rasul, MD, Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA. His research interests include the effects of nutrition and dietary supplementation on multiple outcomes in clinical trials.
Ashar Farooqi, MD, Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA. His research interests include the effects of nutrition and dietary supplementation on multiple outcomes in clinical trials.
Laura A. Lantigua, MBA, Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA. Her research interests include the effects of nutrition and dietary supplementation on multiple outcomes in clinical trials.
Frederick Michaud, BS, Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA. His research interests include the effects of nutrition and dietary supplementation on multiple outcomes in clinical trials.
Sharon Goldberg, MD, Glow Health PA, Bay Harbor Islands, FL, USA. Her research interests include the effects of nutrition and dietary supplementation on multiple outcomes in clinical trials.
Lucas C. Lages, BS, Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA. His research interests include the effects of nutrition and dietary supplementation on multiple outcomes in clinical trials.
Oscar L. Higuera, MD, Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA. His research interests include the effects of nutrition and dietary supplementation on multiple outcomes in clinical trials.
Andrea Fiallo, MD, Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA. Her research interests include the effects of nutrition and dietary supplementation on multiple outcomes in clinical trials.
Eduard Tiozzo, PhD, Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA. His research interests include the effects of nutrition and dietary supplementation on multiple outcomes in clinical trials.
Judi M. Woolger, MD, Department of Medicine, University of Miami Miller School of Medicine, Miami, FL, USA. Her research interests include the effects of nutrition and dietary supplementation on multiple outcomes in clinical trials.
Stephanie Ciraula, BS, Department of Medicine, University of Miami Miller School of Medicine, Miami, FL, USA. Her research interests include the effects of nutrition and dietary supplementation on multiple outcomes in clinical trials.
Armando Mendez, PhD, Department of Medicine, University of Miami Miller School of Medicine, Miami, FL, USA. His research interests include the effects of nutrition and dietary supplementation on multiple outcomes in clinical trials.
Allan E. Rodriguez, MD, Department of Medicine, University of Miami Miller School of Medicine, Miami, FL, USA. His research interests include the effects of nutrition and dietary supplementation on multiple outcomes in clinical trials.
Janet Konefal, PhD, Department of Family Medicine, University of Miami Miller School of Medicine, Miami, FL, USA. Her research interests include the effects of nutrition and dietary supplementation on multiple outcomes in clinical trials.