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

Food Addit Contam Part A Chem Anal Control Expo Risk Assess. 2008 Jul;25(7):872-84. doi: 10.1080/02652030701854758.

Abstract

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 microg l(-1); female = 116.40 +/- 24.26 microg l(-1)) compared with the PL group (male = 83.55 +/- 39.90 microg l(-1); female = 90.47 +/- 25.68 microg 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.

Publication types

  • Randomized Controlled Trial
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Aflatoxins / metabolism
  • Aflatoxins / poisoning*
  • Bentonite / administration & dosage*
  • Bentonite / adverse effects
  • Double-Blind Method
  • Female
  • Food Additives / administration & dosage*
  • Food Additives / adverse effects
  • Ghana
  • Humans
  • Male
  • Metals, Heavy / administration & dosage
  • Metals, Heavy / blood
  • Minerals / administration & dosage
  • Minerals / blood
  • Mycotoxicosis / prevention & control*
  • Risk Factors
  • Sex Factors
  • Statistics as Topic
  • Vitamin A / blood*
  • Vitamin E / blood*

Substances

  • Aflatoxins
  • Food Additives
  • Metals, Heavy
  • Minerals
  • Vitamin A
  • Bentonite
  • Vitamin E