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Nutrients 2019, 11(4), 866; https://doi.org/10.3390/nu11040866

Nationwide Online Survey Enables the Reevaluation of the Safety of Coleus forskohlii Extract Intake Based on the Adverse Event Frequencies

1
Department of Food Function and Labeling, National Institute of Health and Nutrition, National Institutes of Biomedical Innovation, Health and Nutrition, 1-23-1 Toyama, Shinjuku-ku, Tokyo 162-8636, Japan
2
Department of Food Safety and Management, Showa Women’s University, 1-7-57 Taishido, Setagaya-ku, Tokyo 154-8533, Japan
*
Author to whom correspondence should be addressed.
Received: 24 March 2019 / Revised: 9 April 2019 / Accepted: 15 April 2019 / Published: 17 April 2019
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Abstract

The formulations of the functional ingredients of dietary supplements was studied with a small number of subjects, with a particular focus on their effectiveness, but not enough to evaluate their safety. In this regard, the reevaluation and estimation of the safe use of marketed products, with regards to their adverse event (AE) frequencies, are important. To address this issue, a post-marketing nationwide online survey was conducted for the herbal ingredient Coleus forskohlii extract (CFE), a popular weight-loss ingredient. The questionnaire included product names, adherence to the claimed amount, and AE experiences. The safe intake amount was estimated by the relationship between the claimed amount of CFE and the frequencies of AEs of each product. The number of users who experienced AEs was 75 (10.5% of all users). Gastrointestinal symptoms accounted for 92.0% (n = 69) of all AEs, and diarrhea alone accounted for 81.3% (n = 61). The amount of CFE was significantly associated with the occurrence of diarrhea (p = 0.005). The fitted curve showed that the safe intake amount of CFE was less than 250 mg/day; however, considering its effectiveness, 500 mg/day of CFE might be acceptable. In conclusion, nationwide online surveys of users enable us to confirm and reevaluate the safety of herbal supplements. View Full-Text
Keywords: dietary supplements; safe intake; diarrhea; gastrointestinal stress; effectiveness dietary supplements; safe intake; diarrhea; gastrointestinal stress; effectiveness
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Nishijima, C.; Chiba, T.; Sato, Y.; Umegaki, K. Nationwide Online Survey Enables the Reevaluation of the Safety of Coleus forskohlii Extract Intake Based on the Adverse Event Frequencies. Nutrients 2019, 11, 866.

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