title: NovaSil clay intervention in Ghanaians at high risk for aflatoxicosis: II. Reduction in biomarkers of aflatoxin exposure in blood and urine.
abstract: The efficacy of NovaSil clay (NS) to reduce aflatoxin (AF) biomarkers of exposure was evaluated in 656 blood samples and 624 urine samples collected from study participants during a 3-month phase IIa clinical intervention trial in Ghana. NS was delivered before meals via capsules. Serum AFB (1)-albumin adduct was measured by radioimmunoassay and urinary AFM (1) metabolites were quantified by immunoaffinity-high-performance liquid chromatography (HPLC)-fluorescence methods. Levels of AFB (1) -albumin adduct in serum samples collected at baseline and at 1 month were similar (p = 0.2354 and p = 0.3645, respectively) among the placebo (PL), low dose (LD, 1.5 g NS day (-1)), and high dose (HD, 3.0 g NS day (-1)) groups. However, the levels of AFB (1)-albumin adduct at 3 months were significantly decreased in both the LD group (p < 0.0001) and the HD group (p < 0.0001) compared with levels in the PL group. Levels of AFM(1) in urine samples collected at baseline and at 1 month were not statistically different among the three study groups. However, a significant decrease (up to 58%) in the median level of AFM (1) in samples collected at 3 months was found in the HD group when compared with the median level in the PL group (p < 0.0391). In addition, significant effects were found for dose, time, and dose-time interaction with serum AFB(1)-albumin adduct and dose-time interaction with urinary AFM (1) metabolites. The results suggest that capsules containing NS clay can be used to reduce effectively the bioavailability of dietary AF based on a reduction of AF-specific biomarkers.
authors.affiliation: Department of Environmental Toxicology, The Institute of Environmental and Human Health, Texas Tech University, Lubbock, TX, USA.
authors.forename: P
authors.initials: P
authors.lastname: Wang
authors.forename: E
authors.initials: E
authors.lastname: Afriyie-Gyawu
authors.forename: Y
authors.initials: Y
authors.lastname: Tang
authors.forename: N M
authors.initials: NM
authors.lastname: Johnson
authors.forename: L
authors.initials: L
authors.lastname: Xu
authors.forename: L
authors.initials: L
authors.lastname: Tang
authors.forename: H J
authors.initials: HJ
authors.lastname: Huebner
authors.forename: N-A
authors.initials: NA
authors.lastname: Ankrah
authors.forename: D
authors.initials: D
authors.lastname: Ofori-Adjei
authors.forename: W
authors.initials: W
authors.lastname: Ellis
authors.forename: P E
authors.initials: PE
authors.lastname: Jolly
authors.forename: J H
authors.initials: JH
authors.lastname: Williams
authors.forename: J-S
authors.initials: JS
authors.lastname: Wang
authors.forename: T D
authors.initials: TD
authors.lastname: Phillips
mesh_terms: D000293:Adolescent; D000328:Adult; D000348:Aflatoxins / Q000097:blood* / Q000652:urine*; D000538:Aluminum Silicates / Q000008:administration & dosage*; D015415:Biomarkers / Q000097:blood / Q000652:urine; D000077215:Clay; D004311:Double-Blind Method; D005503:Food Additives / Q000008:administration & dosage*; D005869:Ghana; D006801:Humans; D008297:Male; D008875:Middle Aged; D012307:Risk Factors; D013223:Statistics as Topic; D000096702:Aflatoxin Poisoning
chemical_list: D000348:Aflatoxins; D000538:Aluminum Silicates; D015415:Biomarkers; D005503:Food Additives; D000077215:Clay