NovaSil clay does not affect the concentrations of vitamins A and E and nutrient minerals in serum samples from Ghanaians at high risk for aflatoxicosis

• Published in: Food additives & contaminants. Part A, Chemistry, analysis, control, exposure & risk assessment Vol. 25; no. 7; pp. 872 - 884
• Main Authors: Afriyie-Gyawu, E, Wang, Z, Ankrah, N.A, Xu, L, Johnson, N.M, Tang, L, Guan, H, Huebner, H.J, Jolly, P.E, Ellis, W.O
• Format: Journal Article
• Language: English
• Published: London Taylor & Francis Group 01.07.2008; Taylor & Francis
• Subjects: aflatoxicosis; aflatoxin; aflatoxins; Aflatoxins - metabolism; Aflatoxins - poisoning; Bentonite - administration & dosage; Bentonite - adverse effects; Biological and medical sciences; blood serum; clay; diet; dietary minerals; Double-Blind Method; enterosorbent; Female; Food Additives - administration & dosage; Food Additives - adverse effects; Food industries; Food toxicology; Fundamental and applied biological sciences. Psychology; General aspects; Ghana; heavy metals; Humans; Hygiene and safety; intestinal absorption; Male; Metals, Heavy - administration & dosage; Metals, Heavy - blood; micronutrients; minerals; Minerals - administration & dosage; Minerals - blood; Mycotoxicosis - prevention & control; NovaSil clay; nutrient deficiencies; Risk Factors; Sex Factors; Statistics as Topic; vitamin A; Vitamin A - blood; vitamin deficiencies; vitamin E; Vitamin E - blood; Ghana; enterosorbent; minerals; vitamin A; heavy metals; Mycotoxin; Risk; NovaSil clay; Concentration; Inorganic element; Heavy metal; Toxin; Vitamin E; micronutrients; Aflatoxin
• ISSN: 0265-203X; 1944-0049; 1464-5122; 1944-0057
• DOI: 10.1080/02652030701854758

To assess the potential interference of NovaSil (NS) clay with micronutrients in humans, vitamins A and E and minerals (15 nutrient and 15 non-nutrient minerals) were measured in serum samples from a 3-month intervention trial with NS. Participants (n = 177) were randomly divided into three groups that received 3.0 g NS day-1 (high dose, HD), 1.5 g NS day-1 (low dose, LD), or placebo (PL). Levels of vitamins A and E in serum were comparable among the three study groups at baseline, 1 month and 3 months of NS intervention. Gender-stratified non-parametric mixed-effect model analysis showed no significant effects of dose and dose-time interaction for levels of vitamins A and E. A significant time effect was detected; however, it was limited to an increase in vitamin E in the male participants over the course of the study. No significant differences were found in levels of the nutrient and non-nutrient minerals between the HD and PL groups at baseline and 3 months of NS intervention, except for strontium levels. Strontium was significantly increased (p < 0.001) in the HD group (male = 113.65 ± 28.00 μg l-1; female = 116.40 ± 24.26 μg l-1) compared with the PL group (male = 83.55 ± 39.90 μg l-1; female = 90.47 ± 25.68 μg l-1) following the 3-month intervention with NS. These results, combined with safety and efficacy data, confirm that NS clay is highly effective in reducing aflatoxin exposure and acts as a selective enterosorbent that does not affect the serum concentrations of important vitamins and nutrient minerals in humans.