Sustainable enterosorbent strategies for the protection of African populations from aflatoxin (TAM 50)

Approach

The goal of TAM 50 was to continue to evaluate more refined Novasil clays for increased aflatoxin adsorption and to select the most effective and least toxic ones for safety and efficacy verification in rats. A long-term objective was to conduct a Phase IIa trial in Ghana to establish the feasibility of clay addition to the diet of humans who are at a high risk for aflatoxin exposure and aflatoxicosis. This study in Ghana would only occur after a Phase I trial with the same clay in the U.S. had established dosimetry and potential adverse effects of treatment in adult participants.

Achievements

This project initially focused on research in the U.S. to further confirm safety and the minimal effective dose of NovaSil (NS) clay prior to a Phase IIa study in the host country, Ghana. The safety of long-term dietary exposure to NS clay in male and female Sprague-Dawley rats that were fed rations containing up to 2% NS clay for 28 weeks was determined. Various body organs, tissues, and blood were tested. There were no adverse effects of the NS clay on the rats fed five times the clay needed for aflatoxin protection. Results from this study (and other animal studies) supported the further study of NS clay in dietary interventions for populations at high risk for aflatoxicosis. In a Phase I study in Texas, fifty volunteers (20-45 years in age, 23 males and 27 females) were screened for good health History of the Peanut CRSP 1975-2012 185 and were randomly divided into two groups. The low dose group received six capsules containing 1.5 g/day, and the high-dose group received six capsules containing 3.0 g/day for a period of two weeks. NS clay capsules were distributed to each participant three times per day. Blood and urine samples were taken before and after the study for laboratory analysis, hematology, minerals, vitamins A and E, and concentrations of selected electrolytes. There was no evidence of increased risk to humans from NS clay exposure at levels up to 3.0 g/day confirming the safety of this material for further studies.

Focus

Consumer values