NovaSil clay intervention in Ghanaians at high risk for aflatoxicosis. I. Study design and clinical outcomes

Abstract

In a phase I clinical trial in the U.S., NovaSil clay (NS) showed no significant adverse health effects in humans. In this study (3 month duration), a double-blinded, placebo controlled clinical trial was conducted in Ghana to investigate the safety, tolerance, and aflatoxin sorption efficacy of dietary NS. Volunteers (507 subjects, ages from 18 – 58 yrs) were clinically screened to evaluate their general health, pregnancy status, and levels of blood AFB1-Albumin adducts. Of these subjects, 177 (101 males, 76 females) were randomly assigned to 3 groups: high-dose (HD), low-dose (LD) and placebo-control (PL) groups receiving 3.0, 1.5 and 0 g NS/day in capsules. As a safety precaution, 3.0 g NS was selected as the highest dose since it represented the MED (minimal effective dose) of NS for AFs based on previous animal studies. NS capsules were administered to each participant under the supervision of trained study monitors prior to meals. Blood and urine samples were collected for laboratory analysis. Physical examinations were performed monthly and follow-up was taken to record any side effects daily. Ninety-four percent of the participants (166 of 177) completed the study and compliance rate was 97.4%, 96.4%, and 98.5% for HD, LD, and PL groups, respectively. Overall, 99.4% of person-time reported no side effects throughout the study. Mild to moderate health events were recorded in some of the participants. Throughout the study duration, the total reported side effects with respect to complaints were 0.66%, 0.68%, and 0.48% for HD, LD, and PL, respectively. Symptoms included nausea, vomiting, diarrhea, flatulence, abdominal discomfort, heartburn and dizziness. These side effects were neither dose-dependent nor statistically significant among the three groups. Also, some participants (in all groups) reported having increased appetite in the course of the study. No significant differences were shown in hematology, liver and kidney function, electrolytes, and vital signs in the three groups. These findings demonstrate that application of NS clay for the protection of humans at high risk for aflatoxicosis may represent a novel and economically feasible approach