Intervention trial with calcium montmorillonite clay in a south Texas population exposed to aflatoxin.
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.
a Department of Public Health Sciences , University of California , Davis , CA , USA.|b Department of Epidemiology and Biostatistics , University of Texas Health Science Center at San Antonio , San Antonio , TX , USA.
Brad H
BH
Pollock
c Interdisciplinary Faculty of Toxicology , Texas A&M University , College Station , TX , USA.
Sarah
S
Elmore
c Interdisciplinary Faculty of Toxicology , Texas A&M University , College Station , TX , USA.
Amelia
A
Romoser
d Department of Environmental Health Science, College of Public Health , University of Georgia , Athens , GA , USA.
Lili
L
Tang
d Department of Environmental Health Science, College of Public Health , University of Georgia , Athens , GA , USA.
Min-Su
MS
Kang
d Department of Environmental Health Science, College of Public Health , University of Georgia , Athens , GA , USA.
Kathy
K
Xue
b Department of Epidemiology and Biostatistics , University of Texas Health Science Center at San Antonio , San Antonio , TX , USA.
Marisa
M
Rodriguez
b Department of Epidemiology and Biostatistics , University of Texas Health Science Center at San Antonio , San Antonio , TX , USA.
Nicole A
NA
Dierschke
e Arnold School of Public Health , University of South Carolina , Columbia , SC , USA.
Holly G
HG
Hayes
f Department of Clinical Surgery , Texas A&M Health Sciences Center , College Station , TX , USA.
H Andrew
HA
Hansen
b Department of Epidemiology and Biostatistics , University of Texas Health Science Center at San Antonio , San Antonio , TX , USA.
Fernando
F
Guerra
d Department of Environmental Health Science, College of Public Health , University of Georgia , Athens , GA , USA.
Jia-Sheng
JS
Wang
c Interdisciplinary Faculty of Toxicology , Texas A&M University , College Station , TX , USA.
Timothy
T
Phillips
D000328:Adult; D016604:Aflatoxin B1 / Q000008:administration & dosage / Q000097:blood*; D000538:Aluminum Silicates / Q000008:administration & dosage / Q000627:therapeutic use*; D001546:Bentonite / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015415:Biomarkers; D002118:Calcium / Q000008:administration & dosage / Q000627:therapeutic use*; D000077215:Clay; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D011042:Poisons / Q000008:administration & dosage / Q000097:blood*; D013781:Texas
C000615779:ACCS100; D000538:Aluminum Silicates; D015415:Biomarkers; D011042:Poisons; D001546:Bentonite; D016604:Aflatoxin B1; D002118:Calcium; D000077215:Clay
AFB1–lysine adduct; Aflatoxin; biomarkers; calcium montmorillonite clay; clinical intervention trial; enterosorption