Intervention trial with calcium montmorillonite clay in a south Texas population exposed to aflatoxin

ABSTRACT

South Texas currently has the highest incidence of hepatocellular carcinoma (HCC) in the United States, a disease that disproportionately affects Latino populations in the region. Aflatoxin B₁ (AFB₁) is a potent liver carcinogen that has been shown to be present in a variety of foods in the United States, including corn and corn products. Importantly, it is a dietary risk factor contributing to a higher incidence of HCC in populations frequently consuming AFB₁-contaminated diets. In a randomised double-blind placebo controlled trial, we evaluated the effects of a 3-month administration of ACCS100 (refined calcium montmorillonite clay) on serum AFB₁–lysine adduct (AFB-Lys) level and serum biochemistry in 234 healthy men and women residing in Bexar and Medina counties, Texas. Participants recruited from 2012 to 2014 received either a placebo, 1.5 g or 3 g ACCS100 each day for 3 months, and no treatment during the fourth month. Adverse event rates were similar across treatment groups and no significant differences were observed for serum biochemistry and haematology parameters. Differences in levels of AFB-Lys at 1, 3 and 4 months were compared between placebo and active treatment groups. Although serum AFB-Lys levels were decreased by month 3 for both treatment groups, the low dose was the only treatment that was significant (p = 0.0005). In conclusion, the observed effect in the low-dose treatment group suggests that the use of ACCS100 may be a viable strategy to reduce dietary AFB₁ bioavailability during aflatoxin outbreaks and potentially in populations chronically exposed to this carcinogen.

KEYWORDS:

• Aflatoxin
• biomarkers
• AFB₁–lysine adduct
• calcium montmorillonite clay
• clinical intervention trial
• enterosorption

Acknowledgements

The authors thank Texas Enterosorbents Inc. (TxESI) and Premier Research Labs (PRLabs) for providing and packaging the test articles utilised in this study.

Disclosure statement

No potential conflict of interest was reported by the authors.

Additional information

Funding

This work was supported by the National Institute on Minority Health and Health Disparities [grant number NIH RO1 MD005819: T. Phillips, J.-S. Wang and B. Pollock], and the National Cancer Institute [grant number NIH P30 CA054174: I. Thompson]. The NIH had no involvement in the conduct of the research and/or preparation of the article.