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.
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.
Department of Veterinary Integrative Biosciences, Texas A&M University, College Station, TX, USA.
E
E
Afriyie-Gyawu
Z
Z
Wang
N-A
NA
Ankrah
L
L
Xu
N M
NM
Johnson
L
L
Tang
H
H
Guan
H J
HJ
Huebner
P E
PE
Jolly
W O
WO
Ellis
R
R
Taylor
B
B
Brattin
D
D
Ofori-Adjei
J H
JH
Williams
J-S
JS
Wang
T D
TD
Phillips
D000348:Aflatoxins / Q000378:metabolism; D001546:Bentonite / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D005503:Food Additives / Q000008:administration & dosage* / Q000009:adverse effects; D005869:Ghana; D006801:Humans; D008297:Male; D019216:Metals, Heavy / Q000008:administration & dosage / Q000097:blood; D008903:Minerals / Q000008:administration & dosage / Q000097:blood; D015651:Mycotoxicosis / Q000517:prevention & control*; D012307:Risk Factors; D012737:Sex Factors; D013223:Statistics as Topic; D014801:Vitamin A / Q000097:blood*; D014810:Vitamin E / Q000097:blood*; D000096702:Aflatoxin Poisoning
D000348:Aflatoxins; D005503:Food Additives; D019216:Metals, Heavy; D008903:Minerals; D014801:Vitamin A; D001546:Bentonite; D014810:Vitamin E