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Aflatoxins
Aflatoxins and TerreMatrix®
Aflatoxins are naturally occurring mycotoxins that are produced by many species of Aspergillus, a fungus, most notably Aspergillus flavus and Aspergillus parasiticus. Aflatoxins are toxic and among the most carcinogenic substances known. After entering the body, aflatoxins are metabolized by the liver to a reactive intermediate, aflatoxin M1, an epoxide. Aflatoxin is frequently misspelled as aflotoxin and alfatoxin, which could be confused with alpha toxin.
Short-term safety evaluation of processed calcium montmorillonite clay in humans.
Food Addit Contam. 2005 Mar;22(3):270-9. Links
Wang JS, Luo H, Billam M, Wang Z, Guan H, Tang L, Goldston T, Afriyie-Gyawu E, Lovett C, Griswold J, Brattin B, Taylor RJ, Huebner HJ, Phillips TD.
Department of Environmental Toxicology and The Institute of Environmental and Human Health, Texas Tech University, Lubbock, TX 79409-1163, USA. js.wang@ttu.edu
TerreMatrix clay (TMC) provides significant protection from the adverse effects of aflatoxins (AFs) in multiple animal species by decreasing bioavailability from the gastrointestinal tract. It is postulated that TMC clay can be safely added to human diets to diminish exposure and health risks from AF contaminated food. To determine the safety and tolerance of TMC in humans and establish dosimetry protocols for long-term efficacy studies, a randomized and double-blinded phase I clinical trial was conducted. Volunteers (20-45 yr in age), were clinically screened for confirmation of their health status. Fifty subjects (23 males and 27 females) were randomly divided into two groups: The low-dose group received 1.5 g/day, and the high-dose group received 3.0 g/day for a period of 2wk. TMC tablets were manufactured in the same color and size and were distributed to each participant three times a day at designated sites where follow-up was taken to record any side effects and complaints. Blood and urine samples were collected before and after the study for laboratory analysis. All participants completed the trial and compliance was 99.1%. Mild GI effects were reported in some participants. Symptoms included abdominal pain (6%, 3/50), bloating (4%, 2/50), constipation (2%, 1/50), diarrhea (2%, 1/50), and flatulence (8%, 4/50). No statistical significance was found between the two groups for these adverse effects (p > 0.25). No significant differences were shown in hematology, liver and kidney function, electrolytes, vitamins A and E, and minerals in either group. These results demonstrate the relative safety of TMC clay in human subjects and will serve as a basis for long-term human trials in populations at high risk for aflatoxicosis.
Studies:
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