Efficacy on Breast Skin Tension of the Supplement Containing Pueraria Mirifica in Healthy Japanese Females

The objective of this study is to examine how the ingestion of food containing Pueraria mirifica affects the condition of breast skin tension. A randomized, placebo-controlled, double-blind study was conducted to verify breast skin tension. In this study we measured the angle between the inframammary fold (imf) and the highest point of the breast (nipple), tested female’s hormones, and also carried out subjective reporting in form of a questionnaire. The blood and urine tests were evaluated for the assessment of product safety as a secondary endpoint. From all of 113 applicants, 86 were eliminated due to not meeting the inclusion criteria. Among 27 subjects, 14 were withdrawn due to trouble of gauge, and the remaining 13 (Test; 5, Placebo; 8) completed the study. 4（Test; 1, Placebo; 3）were withdrawn from the analysis due to menstruation. Data obtained with 9 subjects (Test; 4, Placebo; 5) was used for the analysis of efficacy. After the 12-week ingestion the test group showed an increasing tendency of the angle of imf and nipple on both breasts, and the angle of both sides of breast showed a significant difference compared to the Placebo. According to the result of the questionnaire, the test group showed a significant difference in tension in the upper breast after 12 weeks, compared to the Placebo. No adverse effects were observed after the ingestion of the test product. We found out that the ingestion of the food containing Pueraria mirifica for 12 weeks resulted in the improvement of tension of upper breast area and the angle between imf and the nipple, which both suggest the improvement of breast shape. In addition, no safety-related matter occurred during the 12-week test period.

Masatomo NAJIMA／ Akinobu MIYATA／ Hiroyuki SASAGAWA

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