Abstract
Background/Aims: Administration of a lactic acid bacterial strain, Lactococcus lactis subsp. lactis JCM 5805 (LC-Plasma), is reported to prevent viral infection via activation of plasmacytoid dendritic cells in mouse and human studies. As it is assumed that LC-Plasma is taken in excess when it is commercially provided as a supplement, we conducted a trial using capsules to give 250 mg LC-Plasma (5 times the effective anti-viral dose) every day for four weeks to healthy volunteers to investigate the safety of excessive intake of LC-Plasma. Trial Design: A randomized, double-blind, placebo-controlled, parallel-group trial was conducted. Methods: Forty healthy subjects were randomly assigned to the LC-Plasma group (daily intake of five capsules containing 50 mg heat-killed LC-Plasma cells per capsule) or the placebo group (daily intake of five placebo capsules with no LC-Plasma). Physical, hematological, biochemical and urinary examinations and medical interviews were used to evaluate safety. Results: No abnormal differences were observed after excessive intake of LC-Plasma capsules when compared to the intake of placebo capsules. Conclusions: There are no safety concerns associated with the excessive intake of heat-killed LC-Plasma capsules.
Highlights
Lactic acid bacteria (LAB) have been traditionally used in the production of fermented foods, such as yogurt and cheese, and are regarded as highly safe food materials
As it is assumed that LC-Plasma is taken in excess when it is commercially provided as a supplement, we conducted a trial using capsules to give 250 mg LC-Plasma (5 times the effective anti-viral dose) every day for four weeks to healthy volunteers to investigate the safety of excessive intake of LC-Plasma
It is reported that LAB have many health functions, such as the regulation of intestinal cells, immune cells and microbiota, and they have been used in the production of many functional health foods [1] [2]
Summary
Lactic acid bacteria (LAB) have been traditionally used in the production of fermented foods, such as yogurt and cheese, and are regarded as highly safe food materials. We previously reported that LC-Plasma induced the production of interferon-α (IFN-α) in an in vitro study [3] and prevented viral infection in mouse and human studies [6]-[11]. The intake of yogurt or supplement containing 50 mg (1.0 × 1011 cells or more) of LC-Plasma activated human pDC and alleviated the symptoms of flu and common cold [9] [10] [11]. To investigate the safety of excessive intake of LC-Plasma, we conducted a trial where healthy volunteers ingested capsules containing 250 mg LC-Plasma (5 times the effective anti-viral dose) every day for four weeks
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