Safety test of a supplement, 5-aminolevulinic acid phosphate with sodium ferrous citrate, in diabetic patients treated with oral hypoglycemic agents | Functional Foods in Health and Disease - Online ISSN: 2160-3855; Print ISSN: 2378-7007 Skip to main content Skip to main navigation menu Skip to site footer Open Menu Functional Foods in Health and Disease - Online ISSN: 2160-3855; Print ISSN: 2378-7007 Home Food Science Publisher Functional Food Center Current Archives About About the Journal Aims and Scope Contact Editing Services Editorial Team Express Peer Review Graphical Abstract Journal Insights Privacy Statement Submissions Announcements Search Search Register Login Home / Archives / Vol. 4 No. 9 (2014): September 2014 / Research Articles Safety test of a supplement, 5-aminolevulinic acid phosphate with sodium ferrous citrate, in diabetic patients treated with oral hypoglycemic agents Authors Naohide Yamashita Department of Advanced Medical Science, Institute of Medical Science, The University of Tokyo, Tokyo, Japan; Atai Watanabe Department of Advanced Medical Science, Institute of Medical Science, The University of Tokyo, Tokyo, Japan; Hikaru Kondo SBI Pharmaceuticals Co., Ltd., Tokyo, Japan Satofumi Kawata SBI Pharmaceuticals Co., Ltd., Tokyo, Japan Tohru Tanaka SBI Pharmaceuticals Co., Ltd., Tokyo, Japan Motowo Nakajima SBI Pharmaceuticals Co., Ltd., Tokyo, Japan DOI: https://doi.org/10.31989/ffhd.v4i9.151 Abstract Objective: This study aimed to examine the safety of 5-aminolevulinic acid phosphate (5-ALA) with sodium ferrous citrate (SFC) in diabetic patients treated with one or more oral hypoglycemic agents (OHAs). Background: Recent intervention studies performed in the USA and Japan have shown that a nutritional supplement of 5-ALA with SFC efficiently reduced blood glucose levels in pre-diabetic population without any adverse events. Thus, it was anticipated that 5-ALA with SFC may potentially be taken as a beneficial supplement by diabetic patients who were being treated with OHA therapy. Nevertheless, it is important to examine its safety and efficacy in diabetic population. Methods: This study was a prospective single-blinded, randomized, placebo-controlled and parallel-group comparison study. Medically treated diabetic patients between the ages of 30 and 75 were recruited from the Tokyo metropolitan area of Japan and 45 subjects were selected after screening. These subjects were randomly assigned to three groups: daily intake of 15mg 5-ALA, 50mg 5-ALA, and a placebo (n=15, respectively). The supplement or placebo was administered for 12 weeks followed by a four week washout period. The primary endpoint was safety and  occurrence of hypoglycemic attack, while the secondary endpoint was changes of fasting blood glucose (FBG) and hemoglobin A1c (HbA1c). Results: Adverse events related to 5-ALA with SFC were not observed in all the groups. Abnormalities in blood and urine tests were not observed either. Significant decrease in FBG was not detected in all the groups. However, there was a small but significant decrease in HbA1c at 4 and 8 week in the 15 mg 5-ALA group. Significant decrease in HbA1c was not observed in the 50 mg 5-ALA group, although a tendency to decrease after 4 weeks was apparent. Conclusion: 5-ALA with SFC is a safe and potentially beneficial supplement if taken by diabetic patients treated with OHAs. Trial registration: UMIN 000008038 Key words: type 2 diabetes, 5-aminolevulinic acid (5-ALA), sodium ferrous citrate (SFC), oral hypoglycemic agent (OHA), hemoglobin A1c (HbA1c), fasting blood glucose (FBG) Downloads [Abstract] [Full Article] Published 2014-09-13 Issue Vol. 4 No. 9 (2014): September 2014 Section Research Articles License Authors retain the copyright of their articles and grant the Functional Food Center (FFC) and its journals the right of first publication under the terms of the Creative Commons Attribution 4.0 International License. This license permits unrestricted use, distribution, and reproduction in any medium, including commercial use, provided the original author(s) and source are properly credited. Authors may post and share their published work freely, provided that the original publication in this journal is acknowledged. By submitting to this journal, authors confirm that their manuscripts are original, not under consideration elsewhere, and that they hold the necessary rights to grant this license. The Functional Food Center encourages open scientific exchange and allows derivative and extended works, provided attribution to the original publication is maintained. About the Journal      Editing Services      Graphical Abstract      Journal Insights        Submissions        Editorial Team       Privacy Statement        Contact        Current        Archives   Open Journal Systems Hosting and Support by: OpenJournalSystems.com