Safety evaluation of excessive intake of calcium-fortified fish sausage to prevent osteoporosis in humans
2010
Murota, I., Maruha Nichiro Holdings Inc., Tsukuba, Ibaraki (Japan). Central Research Inst. | Baba, T. | Shimada, M. | Sato, N.
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 of calcium.
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