Evaluation of safety of excessive intake and efficacy of long-term intake of beverages containing apple polyphenols.

In the present study, a randomized, double-blind, placebo-controlled study was performed to evaluate the safety of an excessive intake and the efficacy of a long-term intake of polyphenols derived from apples for moderately underweight to moderately obese subjects (long-term intake: 94 subjects; excessive intake: 30 subjects). For each trial, the subjects were divided into the following two groups: a group that drank beverages with apple polyphenols (600 mg) (hereinafter referred to as the apple group) and a group that drank beverages without apple polyphenols (hereinafter referred to as the placebo group). For the long-term intake trial, the subjects were given a regular amount of the beverage (340 g) each day for 12 weeks. For the excessive intake trial, the subjects were given three times the regular amount of the beverage each day for 4 weeks. It is noteworthy that the visceral fat area (VFA) of subjects in the apple group for the long-term intake trial had decreased significantly by the 8- and 12-week marks (week 8: p < 0.05; week 12: p < 0.01) compared to the baseline (week 0). The degree of change in VFA experienced by subjects in the apple group compared to those in the placebo group was significantly lower by the 8- and 12-week marks (p < 0.01). Stratified analysis indicated that the VFA of subjects in the apple group that started with a high VFA (VFA > or = 100 cm(2)) had decreased significantly by the 8- and 12-week marks compared to the baseline (week 8: p < 0.05; week 12: p < 0.01). However, no significant change in the VFA of subjects in the apple group that started with a normal VFA (VFA < 100 cm(2)) was exhibited by the 8- and 12-week marks. No clinical problems arose in the blood examinations or physical examinations for the long-term intake trial or the excessive intake trial. No adverse reaction was observed in either trial. These results demonstrated the efficacy and the safety of the beverage with apple polyphenols.