Impact of Probiotic Lacticaseibacillus paracasei Strain Shirota (LcS) on Aflatoxin Exposure among Healthy Malaysian Adults: A Randomized, Double-Blind, Placebo-Controlled Intervention Study.

BACKGROUND

Limited evidence suggests that probiotic Lacticaseibacillus paracasei strain Shirota (LcS) may reduce aflatoxin exposure in Malaysians, though individual factors influencing aflatoxin exposure remain unclear.

OBJECTIVES

This study evaluated the effect of LcS on aflatoxin biomarker concentrations over a 12-wk intervention among healthy Malaysian adults. A secondary objective was to explore the individual factors associated with aflatoxin exposure using baseline data.

METHODS

A randomized, double-blind, placebo-controlled intervention involved healthy Malaysian adults (aged 20-60) of Chinese, Malay, or Indian ethnicities with elevated urinary aflatoxin M1 (AFM1) and serum aflatoxin B1 (AFB1)-albumin concentrations. Hundred and seventy-four (n = 174) subjects were randomly and equally assigned (n = 87/group) to consume either fermented milk with LcS (probiotic) (3 × 1010 CFU/80 mL/bottle) or milk without LcS (placebo) twice/d for 12 wk, with a 4-wk follow-up. Baseline data included sociodemographic characteristics, knowledge, attitude, and practice related to aflatoxin contamination, dietary intake, body weight, and physical activity status. Urine and fasting blood samples were collected every 2 and 4 wk for AFM1 and AFB1-lysine adduct analyses, respectively.

RESULTS

Eighty-five (n = 85) and 82 (n = 82) subjects in the probiotic and placebo groups completed the intervention, respectively. After adjusting for covariates, a significant effect was observed at postintervention in the probiotic group with a 23% reduction in urinary AFM1 concentrations compared with the placebo group (B = -0.26; Exp(B) = 0.77; P = 0.04). Serum AFB1-lysine adduct concentrations remained lower in the probiotic group throughout the study. Both aflatoxin biomarkers significantly differed by ethnicity (AFM1: P = 0.001; AFB1: P = 0.01). Subjects with lower aflatoxin knowledge had significantly higher AFB1-lysine concentrations (mean rank = 95.99) than those with higher knowledge (mean rank = 73.57) (P = 0.04). Urinary AFM1 concentrations were higher with cereal intake (ρ = 0.17, P = 0.03) but lower with protein intake (ρ = -0.18, P = 0.02).

CONCLUSIONS

Ethnicity, knowledge level, and dietary intake influenced aflatoxin exposure. The benefits of consuming LcS to reduce aflatoxin exposure deserve further attention.

TRIAL REGISTRATION NUMBER: This trial is registered in the National Medical Research Register (NMRR-16-2693-3230) and clinicaltrials.gov (NCT03882294).