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薬理と治療
Abstract
Objectives The flavedo of shiikuwasha(Citrus depressa Hayata), a fruit grown in Okinawa, is rich in polymethoxyflavonoids(PMF), especially nobiletin, in comparison with other kinds of citrus. Recent in vitro and in vivo studies have shown that PMF has an effect of improving lipid metabolism and liver function. That is why we conducted an exploratory clinical trial using a hydrous ethanol extract of a Shiikuwasha peel, which includes flavedo, and we were able to confirm that it is also effective on humans. Therefore, this time, we evaluated it by a randomized, double-blind, placebo-controlled, parallel-group comparison study for verification purposes. Methods The subjects were 44 men and women between the ages of 20 and 74 who are developing fatty liver. The test food was in a capsule shape and it contained 20 mg/day of Shiikuwasha extract(2 mg/day was PMF). During the ingestion period of 12 weeks, physical examinations, blood tests, medical interviews, etc., were performed before ingestion as well as 6 and 12 weeks after ingestion. This study was conducted with the approval of the institutional review board. Results 43 people were subject to analysis(PMF group: 21, placebo group(P group): 22). In all cases, triglyceride, total cholesterol, arteriosclerosis index and non/HDL cholesterol were significantly decreased in the PMF group compared to the P group. In γ-GTP, in the subgroup of healthy subjects(PMF group: 16 persons, P group: 18 persons), which excluded 9 persons exceeding 80 U╱L, the PMF group significantly decreased compared to the P group. In the safety assessment, there were no adverse events or abnormal changes in test values due to the test food.Conclusions This study suggested that the Shiikuwasha extract improves lipid metabolism as well as liver function due to the effects of PMF, and the safety of continuous ingestion was also confirmed. (UMIN Trial ID: UMIN000021816)
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