Available online 4 May 2015
Original article
Safety of a Coleus forskohlii formulation in healthy volunteers
Abstract
Coleus forskohlii
(CF) is an Indian plant that has been used in Ayurvedic medicine.
Several trials have reported the weight-loss effects of CF extract. We
investigated the safety and efficacy of CF extract (Forskohlii, DHC
Corporation) in healthy volunteers. A dose escalation study was
performed to determine the type and frequency of adverse events.
Twenty-nine healthy subjects were recruited in an open-label trial and
were administered escalating doses from 250 to 1000 mg over a 4-week
period. Patients were examined on a daily basis for adverse events.
Blood, urine, and stool samples were obtained before and after
supplementation in a subset of 10 subjects to assess the safety of the
supplement. All 29 subjects completed the study. Intake of CF was
associated with minor gastrointestinal adverse events such as soft stool
and diarrhea, which appeared to be dose-related. There were no major
adverse events. At each dose of CF, either 6 or 7 subjects reported
minor GI events. C. forskohlii formulation appears to be well
tolerated in daily oral doses up to 1000 mg, and warrants further
investigation for its efficacy as a long-term anti-obesity intervention.
This study was registered at http://www.umin.ac.jp, as UMIN000008224.
Keywords
- Coleus forskohlii;
- Adverse events;
- Safety;
- Dietary supplements;
- Obesity;
- Ayurveda
Abbreviations
- BMI, body mass index;
- CF, Coleus forskohlii;
- cAMP, cyclic adenosine monophosphate;
- GI, gastrointestinal;
- TSH, thyroid stimulating hormone;
- T3, triiodothyronine;
- T4, thyroxine
- Corresponding
author. Health Science University, Minami-azabu 2-8-12 Nissei-Bldg.
11Fl., DHC Laboratory, Tokyo 106-0047, Japan. Tel.:
+81 3 5442 3945; fax: +81 3 5442 3947.
Copyright © 2015 Published by Elsevier Japan KK
