NutraCea Announces Start of HIV/AIDS Clinical Study at Hadassah University Medical Center
The study will include 140 patients -- some on anti-retroviral drugs, as well as those not taking such drugs -- to determine the effects of a 30-gram, daily dose of RiSolubles from a nutritional and immunological standpoint.
21/06/07 NutraCea, a leader in stabilized rice bran research and technology, announced the commencement of a randomized, placebo-controlled, clinical trial that will test the effects of RiSolubles, a patented, proprietary derivative of stabilized rice bran, on HIV/AIDS patients.
The recruitment phase for the nutrient study is underway. The study will include 140 patients -- some on anti-retroviral drugs, as well as those not taking such drugs -- to determine the effects of a 30-gram, daily dose of RiSolubles from a nutritional and immunological standpoint. The randomized, controlled design of the NutraCea study will examine the effect of RiSolubles, compared to that of a placebo on patients' immune status, well-being and other important parameters," said Prof. Allon Moses, Co-Principal Investigator and Chairman of the Dept. of Clinical Microbiology & Infectious Disease at Hadassah.
"Such a nutrient study will address an important topic in AIDS Medicine: the value of nutrients and specifically, RiSolubles, a derivative of stabilized rice bran, in boosting the immune function beyond what is achieved with anti-retroviral drugs," says Prof. Shlomo Maayan, Co-Principal Investigator of the study, Director of the Hadassah Medical AIDS Center in Jerusalem.
"We were compelled to conduct a study of this nature, based on years of anecdotal reports and recent reports from our feeding programs in Malawi and Central America. The reports suggested that people with HIV/AIDS were gaining weight, feeling more energetic and enjoying a better quality of life. In some patients, laboratory parameters suggested better immune function, as well," said Margie Adelman, Senior Vice President of NutraCea. "We believe our RiSolubles has concentrated doses of certain phyto-nutrients that can possibly account for the testimonials that we are receiving. We knew that the only way to prove it was to engage in a clinical study, such as this one that's designed and performed at the highest medical standards," Adelman added.
"It is our hope that a successful trial will demonstrate that use of our product at the above doses will result in the patients experiencing an increase in their CD4 counts and maybe even a decrease in their viral loads -- two important markers that are commonly being monitored in determining the success of anti-retroviral therapy (ARV). This could have significant implications relative to the tremendous costs to the health community associated with these treatment protocols, not to mention the health benefits to the patients of possibly delaying the onset of ARV therapies and the likelihood of a reduced risk of heart disease, which has recently been shown to be linked to ARV," concluded Ms. Adelman.
"We are very pleased to announce that our first, human-trial study is underway at a highly respected medical institution, renowned for its research in HIV/AIDS; and we hope to demonstrate a new, novel, nutritional approach for millions of people around the world who are suffering from HIV/AIDS," said Brad Edson, President and CEO of NutraCea.