Info

Before

After

Before

After

Ca (mg/l)

91 ± 4.8a

87 ± 11

88 ± 13

91 ± 3.6

Cu (mg/l)

1.01 ± 0.24

0.93 ± 0.21

1.18 ± 0.57

1.17 ± 0.52

Fe (mg/l)

1.05 ± 0.31

1.06 ± 0.44

1.05 ± 0.46

1.10 ± 0.40

K (mg/l)

168 ± 16

164 ± 22

160 ± 25

167 ± 11

Mg (mg/l)

19.6 ± 1.4

18.6 ± 2.6

19.3 ± 2.7

19.6 ± 1.3

Mn (ng/l)

3.9 ± 2.1

3.2 ± 0.9

4.4 ± 5.4

3.1 ± 0.4

Na (mg/ml)

3.12 ± 0.10

3.03 ± 0.35

3.03 ± 0.40

3.15 ± 0.08

Ni (ng/l)

6.8 ± 3

6.8 ± 3

9.3 ± 17

8.2 ± 5.5

P (mg/l)

122 ± 14

111 ± 18

121 ± 25

128 ± 18

Pb (ng/l)

3.4 ± 5.1

3.8 ± 0.33

1.8 ± 1.4

1.9 ± 1.3

S (mg/ml)

1.10 ± 0.08

1.01 ± 0.14*

1.03 ± 0.15

1.05 ± 0.05

Se (mg/l)

0.11 ± 0.01

0.10 ± 0.02

0.11 ± 0.01

0.11 ± 0.01

Si (mg/l)

2.74 ± 0.31

2.83 ± 0.57

3.26 ± 0.84

3.38 ± 0.75

Sr (ng/l)

55 ± 18

74 ± 17 **

54 ± 24

96 ± 24 **

Zn (mg/l)

1.2 ± 0.2

1.3 ± 0.5

1.1 ± 0.3

1.2 ± 0.3

Vitamin A (pmol/l)

2.33 ± 0.42a

2.35 ± 0.47

2.48 ± 0.81

2.59 ± 0.63

Vitamin E (pmol/l)

20.7 ± 6.7

19.2 ± 5.9

22.0 ± 6.8

22.5 ± 5.9

amean ± SD; * p < 0.05, ** p < 0.01 as compared to values before the study.

amean ± SD; * p < 0.05, ** p < 0.01 as compared to values before the study.

toms (or complaints) were recorded thereafter. Statistically, no significant difference was observed for these adverse symptoms between the low- and the high-dose groups. All reported side-effects, with one exception, were assessed to be mild, and there was no significant difference between the two treatment groups (Wang et al., 2005).

Thus, the consumption of NovaSil™ capsules at 1.5-3.0 g/day by healthy human subjects for 14 days was relatively safe based on biochemical and hematological parameters and physical examinations. Several parameters, such as red blood cell counts, hemoglobin, total protein, albumin, ALT, and sulfur, decreased significantly in blood samples collected after treatment in the low-dose group, however, none of the parameters were significantly different from normal in blood samples from the high-dose group. All of the observed changes were within the normal range of clinical references. Some clay minerals are postulated to sorb vitamins. In this study there were no statistical differences in serum levels of vitamins A and E after treatment with either dose of NovaSil™ (Table 2). Thus, NovaSil™ can bind aflatoxins but does not interact with vitamins A or E. There were no significant differences in the levels of the minerals analyzed, with two exceptions: lower inorganic sulfur concentration in the low-dose group and higher strontium concentrations in both groups (Table 2). The clinical significance of these findings is not yet known (Wang et al. 2005).

Conclusions

In conclusion, clay-based enterosorbents that are selective for aflatoxins, e.g., NovaSil™, offer a practical, beneficial, and economically feasible solution for the aflatoxin problem, particularly in developing countries. Notably, NovaSil™ is unique in that it diminishes the bioavailability of aflatoxins from the gastrointestinal tract, thus minimizing exposure and health risks to the consumer. Both the chronic animal and short-term human feasibility studies are consistent with the hypothesis that NovaSil™ clay in human diets could prevent or significantly reduce exposure to aflatoxins and reduce or eliminate the adverse effects known to occur in humans that chronically consume aflatoxin-contaminated foods. The relative safety and efficacy of dietary NovaSil™ clay in the animal models, coupled with the results of the short-term human feasibility trial, served as the basis for initiating a three-month phase II intervention trial of dietary NovaSil™ clay in human subjects. Clay-based enterosorbents, and other sorbent materials that may be added to the diet, must be rigorously tested in appropriate animal models to determine their potential for nutrient interactions and toxicity. Importantly, all enterosorbents should be routinely evaluated to confirm their efficacy and safety before being considered for possible human applications.

Acknowledgments

Supported in part by USAID LAG-G-00-96-90013-00 and NIEHS P42-ES04917.

References

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