Safety evaluation of excessive intake of calcium-fortified fish sausage to prevent osteoporosis in humans

Abstract

This study attempted to clarify the safety of excessive intake (400 mg) of calcium-fortified fish sausage, a special health food in Japan, in the prevention of osteoporosis. Safety was evaluated based on an open-label human trial in which 20 healthy subjects took 3 times the recommend amount of fish sausages a day for 4 weeks. Adverse events were assessed, and physical measurements, laboratory assessment and nutrition were analyzed. During the 4-week safety evaluation, no clinical changes were found in any of the subjects. Thus the daily intake of fish sausage appears to be safe as a means to obtain the daily requirements.