Clinical Safety of Nutri-PEITC Jelly: A Pre-Post Study in Healthy Volunteers

Abstract

β-phenylethyl isothiocyanate (PEITC), a phytochemical, promotes the detoxification of carcinogen, and inhibits the proliferation of cancer cells. Nutri-PEITC Jelly is a food gel providing both nutrients and functional benefits. Pharmacokinetics and 5-day tolerability studies revealed rapid absorption and excretion of PEITC in Nutri-Jelly within 24 hours without accumulation. However, information on the long-term safety of Nutri-PEITC Jelly is lacking. This pre-post study was conducted to evaluate the safety of 200 g Nutri-PEITC Jelly (giving 20 mg PEITC) daily intake for 35 days in 12 healthy volunteers (6 male and 6 female, average age 29.3±5.8 years old). All outcomes were measured at 0, 1, 3, and 5 weeks after Nutri-PEITC Jelly intake, and also 2 weeks after stopping the jelly intake. The results showed adverse events found in 16% of participants including oral discomfort and abdominal bloating. All symptoms were mild, transient, and subsided without treatment. Complete blood count, liver and kidney functions, and clinical blood chemistry slightly changed but within the normal ranges. The average level of hematocrit was significantly decreased after 3 weeks of intake but resumed afterward.  The average level of uric acid was reduced after 5 weeks of intake but resumed after stopping the intake. The average platelet counts did not change during the intake period but increased after stopping the intake. All participants completed the study with no drop-outs. In conclusion, our results demonstrate no significant adverse events of Nutri-PEITC Jelly (containing 20 mg PEITC) after 35-day intake.