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健常な日本人男女を対象としたレモン由来酵素処理ヘスペリジンによる顔のむくみ低減効果の検証―ランダム化プラセボ対照二重盲検クロスオーバー比較試験―
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Abstract
Objectives The aim of this study was to examine the effect of enzyme-treated lemon-derived hesperidin(LEH)on healthy Japanese subjects experiencing daily facial swelling. Methods This randomized, double-blind, crossover, placebo-controlled study enrolled healthy Japanese subjects(n=88)who were experiencing daily facial swelling. Participants were randomly assigned into the LEH and placebo groups(n=44 per group)using a computerized random-number generator and ingested either one LEH tablet or one placebo tablet per day after dinner. The study design incorporated a two-week intervention period followed by a washout period of two weeks. Subjective symptoms of facial swelling were evaluated by a visual analog scale as the primary outcome. Additionally, subjective symptoms associated with facial skin texture, face volume(assessed by photo-analysis), calf volume and circumference, and blood pressure were evaluated as secondary outcomes. Results The per-protocol set comprised 43 participants in each group. Among the subjective symptoms, the LEH ingestion contributed to the alleviation of swelling of the face and eye contours in the morning. Additionally, swelling of the eye contours and dullness of the skin under the eyes in the evening were improved by LEH intake. No adverse effects were associated with LEH observed. Conclusions Intake of LEH tablets for two weeks improved facial swelling in the morning. LEH may also improve puffy eyes, dullness under the eyes and calf swelling. Trial registration UMIN-CTR: UMIN000031609 Foundation SAPPORO HOLDINGS LTD.
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