Randomized, triple-blind, placebo-controlled study to evaluate the safety of 6′-Sialyllactose in healthy adults

Abstract

Sialyllactoses (SL) are an abundant component of human milk. There have been many studies on the biological effects of SL in humans. SL can be produced using an economical method of enzyme synthesis. Although the European Food Safety Authority has published the human safety and appropriate intake dose of 6′-SL sodium salt as a novel food, it has suggested that the appropriate dose for particular medical purposes be judged on a case-by-case basis. Also, as revealed in the same report, there are no data on toxicity when 6′-SL is used in human intervention. However, clinical studies have only confirmed the safety of 3′-SL for therapeutic intervention in humans, and the safety for therapeutic use of 6′-SL, which is more abundant than 3′-SL in human milk, has not been confirmed. In this study, to determine the safety of 6′-SL use in humans, participants were randomly assigned to the placebo (maltodextrin) and 6′-SL groups, and then 3 g of powder was orally administered twice a day for 12 weeks. There were no serious adverse reactions, such as life-threatening complications requiring hospitalization, causing disability, or causing deformity during the use of 6′-SL. There were no clinically significant differences among the baseline, sixth, and twelfth week clinical chemistry tests, such as aspartate aminotransferase, alanine aminotransferase, and creatinine. Most of the adverse reactions were gastrointestinal problems such as diarrhea, abdominal discomfort, and bloating, with no significant difference in the proportions between the placebo and 6′-SL groups. These results support the safety of the 6′-SL for human use.