Preclinical safety evaluation of a probiotic yogurt made with tumbo pulp (Passiflora tripartita Kunth)

Abstract

Abstract A probiotic yogurt made from the pulp of the tumbo fruit (Passiflora tripartita Kunth) possesses antioxidant capacity, physicochemical and microbiological quality and stability; however, it needs to be safe for later studies of clinical functionality. The present study would be considered as a precursor to the preclinical safety evaluation of a functional food by in vivo toxicological testing. The study aimed to evaluate the preclinical safety of yogurt made from the pulp of the tumbo fruit (P. tripartita). The toxicological studies proposed were based on the OECD 423:2001 standard on Acute Oral Toxicity, performing the peroral administration of the probiotic yogurt at a dose of 2000 mg/kg one-time in a group of randomized male rats, for its evaluation during 14 days compared to a control group; and on the OECD 407: 2008 on Repeated Dose Oral Toxicity, a daily dose of 2000 mg/kg of the yogurt was administered for 28 days in male rats, considering the evaluation of their clinical, hematological and biochemical parameters, to determine any possible toxic effect produced by the probiotic formulation. The results showed that in both toxicological studies, no adverse alterations were detected in their clinical signs, relative organ weights and hematological and biochemical profiles. In addition, a possible improvement in the immunological status, liver function and hematological profile was evidenced as a finding. In conclusion, it was possible to establish knowledge on the preclinical safety of the formulation of a probiotic yogurt made with tumbo fruit pulp, obtaining a NOAEL (No Observed Adverse Effect Level) value higher than 2000 mg/kg body weight in male rats.