NovaSil clay (NS) provides significant protection from the adverse effects of aflatoxins (AF) in multiple animal species by decreasing bioavailability from the gastrointestinal tract. It is postulated that NS clay can be safely added to human diets to diminish exposure and health risks from AF contaminated food. To determine the safety and efficacy of NS in humans, a randomized, double-blinded, and placebo controlled phase IIa clinical trial was conducted in 177 healthy Ghanaian volunteers who received NS clay capsules either in 1.5 g/day (low dose), 3.0 g/day (high dose), or placebo for a period of 3 months. The efficacy of NS for reducing AF exposure was evaluated by measuring serum AF-albumin adducts in more than 700 serum samples collected at baseline, 1, 3, and 4 months using radioimmunoas say. Levels of serum AF-albumin adduct at baseline were comparable for the 3 treatment arms with the average 1.563±0.315, 1.505±0.322, and 1.493±0.375 pmol AF/mg albumin for the low dose, high dose, and the placebo groups, respectively. No statistical significance (P=0.345) was found among groups of the low dose (1.214±0.215 pmol AF/mg albumin), the high dose (1.168±0.244 pmol AF/mg al bumin), and the placebo (1.253±0.335 pmol AF/mg albumin) in samples collected at 1 month of the trial. However, the levels of serum AF-albumin adduct in samples collected at 3 months of the trial were significantly decreased in both low dose group (0.894±0.155 pmol AF/mg albumin, P<0.0001) and high dose group (0.900±0.156 pmol AF/mg albumin, P<0.0001) compared to the levels of the placebo group (1.195±0.216 pmol AF/mg albumin). Mixed effect model analysis revealed significant dose/time interactions (P<0.001). These results suggest that the three-month intervention trial with NovaSil significantly decreased serum levels of AF-albumin adduct, a long-term biomarker for AF exposure.
- Clinical intervention trial,
- Serum aflatoxin-albumin adduct levels,
- Novasil clay
Available at: http://works.bepress.com/evans_afriyie-gyawu/47/