薬理と治療

Abstract

Objectives　This randomized, placebo-controlled, double-blind, parallel-group trial aimed to determine the effects of raw shark liver oil on healthy Japanese adults. Methods　Healthy Japanese subjects（n＝56）were included and randomly allocated into two groups（n＝28, each）using a computerized random number generator. The active group consumed four capsules that contained raw shark liver oil daily for 12 weeks, whereas the control group consumed four placebos. The primary outcome was the comparison of the vitality（VT） scale of Medical Outcomes Study Short-Form 36-Item Health Survey（SF-36）between the two groups. Secondary outcomes were SF-36 scales（excluding VT）, visual analog scale of fatigue, immunological assessment, skin moisture, Japanese rhino-conjunctivitis quality of life questionnaire individual scores, questionnaire assessment using the practical guideline for managing allergic rhinitis in Japan, and salivary immunoglobulin A. Results　In each group, 28 subjects were analyzed as per-protocol datasets. In the active group, VT values at 8 and 12 weeks, and the general health of SF-36 values at 12 weeks afterintervention were significantly higher than those in the placebo group（P＜0.05）. In the sub-group analysis of the age of ≥ 50 years or ≥ 60 years, some immune indexes significantly improved in the active group in comparison with the placebo group. Furthermore, in the subjects with improved SF-36 at 12 weeks after intervention, the number of cases with improved immune index was significantly higher in the active group than in the placebo group. No adverse events related to the test products were reported. Conclusions　We found that raw shark liver oil consumption enhances immunity, improves subjective health status, energy, and VT, and reduces fatigue in healthy Japanese adults. Trial registration　UMIN-CTR: UMIN000040492 Foundation　EGAO CO., LTD.