Safety assessment of PureSorb-Q40 in healthy subjects and serum coenzyme Q10 level in excessive dosing

• NUKUI Kazuki

  Nisshin Pharma Inc.

• MATSUOKA Yuki

  Nisshin Pharma Inc.

• YAMAGISHI Toshihiko

  Nisshin Pharma Inc.

• MIYAWAKI Hiromi

  Miyawaki Orthopedic Clinic

• SATO Kiyoshi

  Nisshin Pharma Inc.

書誌事項

タイトル別名

• Safety Assessment of PureSorb-QTM40 in Healthy Subjects and Serum Coenzyme Q10 Level in Excessive Dosing

抄録

PureSorb-Q^TM40 (water-soluble type CoQ₁₀ powder, CoQ₁₀ content is 40 w/w%; hereinafter referred to as P40) is reported in the single-dose human and rat studies to have a greater absorption rate and absorbed volume of CoQ₁₀ even taken postprandially, than those of regular CoQ₁₀, which is lipid-soluble and generally taken in the form of soft-gel capsules. Thus, it was anticipated that the serum CoQ₁₀ level might be higher with P40 tablets than with soft-gel capsules, even for the same dose of CoQ₁₀. In the present study, in order to confirm the safety and measure the serum CoQ₁₀ level for the case of an excessive dose of P40, a double-blinded Placebo controlled comparative study was conducted on 46 healthy volunteers and they were randomly divided into two groups. The P40 tablets or placebo were repeatedly taken by the volunteers. As the result of the study, for the group of taking 2,250 mg/d of P40 (that is, 900 mg/d of CoQ₁₀) for 4 consecutive wk, the serum CoQ₁₀ level peaked at 2 wk after the start of intake at 8.79±3.34 μg/mL, and at 4 wk, it was at the level of 8.33±4.04 μg/mL. At 2 wk from withdrawal of intake, the serum CoQ₁₀ level decreased to 1.30±0.49 μg/mL. The serum CoQ₁₀ levels at these three points were significantly higher than those of the first day of intake and the Placebo group, which had no significant change throughout the study. Furthermore, P40 intake did not cause any significant changes in symptoms or clinical laboratory results as assessed by physical, hematological, blood biochemical or urinalysis tests. Physician examinations also did not reveal any abnormalities. These results confirm that P40 is an extremely safe material and it can produce better absorption of CoQ₁₀.

収録刊行物

• Ｊｏｕｒｎａｌ　ｏｆ　Ｎｕｔｒｉｔｉｏｎａｌ　Ｓｃｉｅｎｃｅ　ａｎｄ　Ｖｉｔａｍｉｎｏｌｏｇｙ

  Ｊｏｕｒｎａｌ　ｏｆ　Ｎｕｔｒｉｔｉｏｎａｌ　Ｓｃｉｅｎｃｅ　ａｎｄ　Ｖｉｔａｍｉｎｏｌｏｇｙ 53 (3), 198-206, 2007

  一般財団法人 学会誌刊行センター

キーワード

• coenzyme Q₁₀
• water-soluble
• PureSorb-Q^TM40
• toxicity
• clinical trial

詳細情報

• CRID: 1390282681302581760
• NII論文ID: 110006317278
• NII書誌ID: AA00703822
• DOI: 10.3177/jnsv.53.198
• COI: 1:CAS:528:DC%2BD2sXns1Omtrc%3D
• ISSN: 18817742
• ISSN: 03014800
• NDL書誌ID: 8785654
• Web Site: https://ndlsearch.ndl.go.jp/books/R000000004-I8785654
• Web Site: https://search.jamas.or.jp/link/ui/2008002009
• 本文言語コード: en
• データソース種別:
  • JaLC
  • NDL
  • Crossref
  • CiNii Articles
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