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A Coleus forskohlii extract improves body composition in healthy volunteers: An open-label trial
Personalized Medicine Universe 2 (2013) 25e27
Contents lists available at SciVerse ScienceDirect
Personalized Medicine Universe journal homepage: www.elsevier.com/locate/pmu
Original article
A Coleus forskohlii extract improves body composition in healthy volunteers: An open-label trial Seika Kamohara a, b, *, Somboon Noparatanawong b a b
Health Science University, Fujikawaguchiko-machi, Yamanashi, Japan DHC Corporation, Minami-azabu 2-7-1, Minato-ku, Tokyo, Japan
a r t i c l e i n f o
a b s t r a c t
Article history: Received 8 January 2013 Accepted 22 March 2013
Purpose: Coleus forskohlii (CF) is a south Asian herb that has been historically used in Ayurvedic medicine. The root of CF contains forskolin, a biologically active compound that has been demonstrated to improve well-being in some individuals by promoting lean body mass and supporting healthy metabolic function. We conducted an open-label study to evaluate the efficacy of CF root extract for weight management. Methods: After obtaining informed consent, 15 healthy volunteers participated in an 8-week open-label study. The subjects received 500 mg of CF extract (10% forskolin) twice a day with their meals. Body composition measurements were conducted using a bioelectric impedance analyzer once each week. Body weight (kg), fat content (kg), lean body mass (kg), and basal metabolic rate (kcal/day) were also measured and documented. Results: Of the 15 subjects, 12 (mean age 32.2 2.3 years) completed the study. Significant decreases compared with baseline were observed after 8 weeks for body mass index (BMI) (24.92 0.87 to 23.99 0.86 kg/m2, p ¼ 0.0038), body weight (66.33 3.00 to 63.96 3.10 kg, p ¼ 0.0038), fat content (29.64 2.19 to 27.77 2.27 kg, p ¼ 0.0038), lean body mass (44.34 2.98 to 43.93 3.01 kg, p ¼ 0.0044) and basal metabolic rate (1379.1 74.4 to 1363.9 77.5 kcal, p ¼ 0.0254). Conclusion: These findings suggest that CF root extract has potential as an adjunct therapy for the treatment of obesity. Further studies using double-blind, randomized, placebo-controlled designs are warranted to conclusively demonstrate the effectiveness of CF root extract in personalized supplements and/or pharmacological interventions. Copyright Ó 2013, International Society of Personalized Medicine. Published by Elsevier B.V. All rights reserved.
Keywords: Coleus forskohlii Phytotherapy Forskolin Obesity Ayurveda
1. Introduction Obesity has become one of the major challenges for general public health worldwide. The scarcity of effective therapeutics for obesity demands the development of tailor-made approaches from the viewpoint of personalized medicine. Although there are currently few effective pharmacological treatments for obesity, there is a growing body of literature showing the potential efficacy of botanical medicine and phototherapy as complementary therapy. Several botanicals, including Coleus forskohlii (CF), have been
Abbreviations: CF, Coleus forskohlii; BMI, body mass index; cAMP, cyclic adenosine monophosphate; GI, gastrointestinal. * Corresponding author. Health Science University, Minami-azabu 2-8-12, Nisseibldg. 11fl. DHC, Tokyo 106-0047, Japan. Tel.: þ81 3 5442 3945; fax: þ81 3 5442 3947. E-mail address: [email protected] (S. Kamohara).
considered and tested for the treatment of obesity and for the promotion of healthy weight management. CF is an Indian plant that has been used in traditional Indian medicine, Ayurveda [1,2]. CF belongs to the family Labiatae, also known as the mint family (Fig. 1). The plant is rich in various kinds of alkaloids. The root portion of CF contains forskolin, a biologically active compound [1,2]. Forskolin is a diterpene that acts as an adenylate cyclase activator [3]. Adenylate cyclase is involved in the production of cyclic adenosine monophosphate (cAMP), a significant biochemical agent in metabolic processes. cAMP induces biochemical events that trigger metabolic processes and dietinduced thermogenesis, increase lean body mass, and stimulate the loss of body fat. Consequently, the use of CF extract may be beneficial for maintaining healthy body composition and lean body mass levels. In ovariectomized rats, the administration of CF extract reduced body weight, food intake, and fat accumulation [4]. Several clinical trials have reported an anti-obesity effect for CF extract [5,6].
2186-4950/$ e see front matter Copyright Ó 2013, International Society of Personalized Medicine. Published by Elsevier B.V. All rights reserved. http://dx.doi.org/10.1016/j.pmu.2013.04.003
26
S. Kamohara, S. Noparatanawong / Personalized Medicine Universe 2 (2013) 25e27
2.3. Study drug C. forskohlii (standardized powder extract formulation) was provided to the participants in a tablet form (Forskohlii, DHC Corporation, Tokyo, Japan). One tablet contained 250 mg of CF extract, including 10% forskolin. 2.4. Statistical analysis For statistical analysis, values obtained after the 8-week supplementation period were compared to those at baseline using the Wilcoxon t-test. A p value of less than 0.05 was considered to be statistically significant. 3. Results Twelve subjects (5 men and 7 women, mean age 32.0 2.3 years) completed the study. Significant decreases compared to baseline were detected after 8 weeks for BMI (24.92 0.87 to 23.99 0.86 kg/m2, p ¼ 0.0038), body weight (66.33 3.00 to 63.96 3.10 kg, p ¼ 0.0038), and fat content (29.64 2.19 to 27.77 2.27 kg, p ¼ 0.0038) (Table 1). Lean body mass also significantly decreased (44.34 2.98 to 43.93 3.01 kg, p ¼ 0.0044), as did basal metabolic rate (1379.1 74.4 to 1363.9 77.5 kcal, p ¼ 0.0254). There were no significant differences between baseline and week 8 in terms of systolic and diastolic blood pressure. Three subjects reported abdominal discomfort, such as increased bowel movements, soft stools, and/or diarrhea. No other clinically significant adverse events were detected or noted. 4. Discussion Fig. 1. Botanical aspects of Coleus forskohlii. A. C. forskohlii is an Indian herb, which belongs to the family Labiatae. B. Its root has been used in traditional Indian medicine, Ayurveda.
The purpose of this study was to investigate the efficacy of CF extract for weight-management in Japanese subjects. 2. Methods
C. forskohlii (CF) has been cultivated for the use of its root, and is commonly consumed as part of an ordinary diet in foods such as pickles [1,2]. Its root has also been used in traditional Indian medicine, Ayurveda, for the treatment of cardiovascular diseases, hypertension, abdominal pain, and constipation [2,5,7]. Recently, CF root extract has been widely included as an ingredient of functional foods and dietary supplements used for weight loss and weight management. There were 2 key findings from this study. Firstly, 8 weeks of CF supplementation (500 mg twice a day) promoted weight loss, and
2.1. Subjects and study protocol Eligible volunteer participants were male and female subjects aged 20 years or older without any organ dysfunction who had never experienced psychological and/or chronic diseases. After obtaining informed consent, 15 healthy volunteers participated in an 8-week open-label trial. Subjects received 500 mg of CF extract (10% forskolin) twice a day with their meals. 2.2. Body composition measurements Body composition measurements were taken using a bioelectric impedance analyzer (Tanita Corporation, Tokyo, Japan) on a weekly basis. Body weight (kg), fat content (kg), lean body mass (kg), and basal metabolic rate (kcal) were obtained. Obesity was defined in terms of body mass index (BMI), calculated as body weight divided by the square of height (kg/m2). Lean body mass was the mass of the body excluding fat mass. Adverse events were recorded on a daily basis.
Table 1 Effects of Coleus forskohlii extract on body composition. Baseline BMI Body weight (kg) Fat content (kg) LBM (kg) BMR (kcal) Systolic BP (mmHg) Diastolic BP (mmHg)
4 weeks
8 weeks
p value
24.92 0.87 66.33 3.00
24.26 0.84 64.61 2.99
23.99 0.86 63.96 3.10
p ¼ 0.0038 p ¼ 0.0038
29.64 2.19
28.75 2.20
27.77 2.27
p ¼ 0.0038
44.34 2.98 1379.1 74.4 116 5
44.03 3.02 1367.6 76.0 116 5
43.93 3.01 1363.9 77.5 114 5
p ¼ 0.0044 p ¼ 0.0254 p > 0.05 (n.s)
73 5
74 5
73 4
p > 0.05 (n.s)
N ¼ 12; BMI, body mass index; LBM, lean body mass; BMR, basal metabolic rate; BP, blood pressure; n.s., not significant. Values are represented as mean standard error. The p values indicate the difference between values at baseline and at 8 weeks.
S. Kamohara, S. Noparatanawong / Personalized Medicine Universe 2 (2013) 25e27
secondly, CF supplementation was associated with adverse gastrointestinal (GI) events. Several clinical trials have reported the effects of CF extract on weight loss. An 8-week open-label study in 6 overweight but otherwise healthy women (BMI > 25 kg/m2) who received oral CF extract (containing 50 mg per day of forskolin), found significant reductions in body weight and fat content [5]. In a randomized, double-blind, placebo-controlled 12-week trial, significant weight loss was observed in 30 overweight/obese men after taking CF extract (containing 250 mg per day of forskolin) [8]. A randomized, double-blind, 12-week clinical trial reported that overweight/obese women (BMI 25e35 kg/m2) taking CF extract (containing 50 mg per day of forskolin) experienced weight loss, while the placebo group experienced weight gain. Heart rate, blood pressure, and blood lipid levels were unaffected. No clinically significant side effects were observed [6]. The results of this study were consistent with those of these previous reports, showing effects on weight loss and weight management. In Ayurvedic medicine, it has been reported that CF extract supplementation can lead to mild improvements in systolic and diastolic blood pressure in geriatric subjects with hypertension [7]. Forskolin has also been shown to lower blood pressure in hypertensive rats [1,2]. However, in this study, CF extract had no significant effect on blood pressure. The previous randomized, doubleblind trial in mildly overweight women also found that CF had no effect on blood pressure [6]. These data suggest that CF extract or forskolin may improve hypertension, but have no effect in patients with normal blood pressure. Forskolin, a major constituent of CF extract, activates adenylate cyclase and increases the production of cAMP [9,10]. Increased levels of cAMP induced by forskolin stimulate lipolysis in adipose tissue. Enhanced lipolysis increases fat degradation in the body and may promote weight loss [4]. Traditionally, CF root has been used in Ayurvedic medicine for the treatment of constipation. The contemporary use of CF extract in dietary supplements for weight loss has been anecdotally associated with the side effects of soft stool and diarrhea. In this study, 3 subjects reported mild GI adverse events. We performed a dose escalation study of CF supplementation to assess the frequency and severity of GI adverse events. This 4-week dose escalation study showed that the intake of CF extract was associated with mild GI adverse events, which appeared to be dose-related [11]. The mechanism by which GI events are induced is not fully understood, but one possibility is that cAMP-induced efflux of chloride ions from the intestinal membrane causes GI events such as soft stool and diarrhea. We suggest that a cAMP-dependent chloride channel, known as the cystic fibrosis transmembrane conductance regulator (CFTR), is responsible for the secretion of water into the lumen [12]. Theoretically, increased levels of cAMP in the intestine induced by the intake of CF extract could cause secretion of chloride ions into the lumen via the CFTR. This could result in secretion of water, which manifests as soft stool and diarrhea in subjects who are more susceptible to these effects.
27
5. Conclusion In summary, we showed that the intake of CF extract improved body composition in healthy volunteers. Our findings indicate that CF extract has potential as a complementary therapy in the treatment of obesity. Further studies with double-blind, randomized, placebo-controlled designs are warranted to conclusively demonstrate the effectiveness of CF extract for weight loss and weight management.
Funding This work was supported by a research grant from the DHC Corporation.
Conflict of interest Seika Kamohara is a research advisor for the DHC Corporation laboratory. Somboon Noparatanawong is an employee of the DHC Corporation.
Acknowledgments The authors are grateful to Dr. L. Todd Landreneau for preparing this manuscript.
References [1] de Souza NJ, Dohadwalla AN, Reden J. Forskolin. a labdane diterpenoid with antihypertensive, positive inotropic, platelet aggregation inhibitory, and adenylate cyclase activating properties. Med Res Rev 1983;3:201e19. [2] Premila MS. Ayurvedic herbs: a clinical guide to the healing plants of traditional Indian medicine. New York: Routledge; 2006. [3] Burns TW, Langley PE, Terry BE, et al. Comparative effects of forskolin and isoproterenol on the cyclic AMP content of human adipocytes. Life Sci 1987;40:145e54. [4] Han LK, Morimoto C, Yu RH, et al. Effects of Coleus forskohlii on fat storage in ovariectomized rats. Yakugaku Zasshi 2005;125:449e53. [5] Lieberman SA. A new potential weapon for fighting obesity. Forskolindthe active diterpene in Coleus. Altern Complement Ther 2004;10:330e3. [6] Henderson S, Magu B, Rasmussen C, et al. Effects of Coleus forskohlii supplementation on body composition and hematological profiles in mildly overweight women. J Int Soc Sports Nutr 2005;2:54e62. [7] Jagtap M, Chandola HM, Ravishankar B. Clinical efficacy of Coleus forskohlii (Willd.) Briq. (Makandi) in hypertension of geriatric population. Ayu 2011;32: 59e65. [8] Godard MP, Johnson BA, Richmond SR. Body composition and hormonal adaptations associated with forskolin consumption in overweight and obese men. Obes Res 2005;13:1335e43. [9] Metzger H, Lindner E. The positive inotropic-acting forskolin, a potent adenylate cyclase activator. Arzneimittelforschung 1981;31:1248e50. [10] Ammon HP, Müller AB. Forskolin: from an ayurvedic remedy to a modern agent. Planta Med 1985;51:473e7. [11] Kamohara S, Noparatanawong S. Safety and efficacy of a Coleus forskohlii formulation in healthy volunteers, unpublished results. [12] Thiagarajah JR, Verkman AS. CFTR pharmacology and its role in intestinal fluid secretion. Curr Opin Pharmacol 2003;3:594e9.
Contents lists available at SciVerse ScienceDirect
Personalized Medicine Universe journal homepage: www.elsevier.com/locate/pmu
Original article
A Coleus forskohlii extract improves body composition in healthy volunteers: An open-label trial Seika Kamohara a, b, *, Somboon Noparatanawong b a b
Health Science University, Fujikawaguchiko-machi, Yamanashi, Japan DHC Corporation, Minami-azabu 2-7-1, Minato-ku, Tokyo, Japan
a r t i c l e i n f o
a b s t r a c t
Article history: Received 8 January 2013 Accepted 22 March 2013
Purpose: Coleus forskohlii (CF) is a south Asian herb that has been historically used in Ayurvedic medicine. The root of CF contains forskolin, a biologically active compound that has been demonstrated to improve well-being in some individuals by promoting lean body mass and supporting healthy metabolic function. We conducted an open-label study to evaluate the efficacy of CF root extract for weight management. Methods: After obtaining informed consent, 15 healthy volunteers participated in an 8-week open-label study. The subjects received 500 mg of CF extract (10% forskolin) twice a day with their meals. Body composition measurements were conducted using a bioelectric impedance analyzer once each week. Body weight (kg), fat content (kg), lean body mass (kg), and basal metabolic rate (kcal/day) were also measured and documented. Results: Of the 15 subjects, 12 (mean age 32.2 2.3 years) completed the study. Significant decreases compared with baseline were observed after 8 weeks for body mass index (BMI) (24.92 0.87 to 23.99 0.86 kg/m2, p ¼ 0.0038), body weight (66.33 3.00 to 63.96 3.10 kg, p ¼ 0.0038), fat content (29.64 2.19 to 27.77 2.27 kg, p ¼ 0.0038), lean body mass (44.34 2.98 to 43.93 3.01 kg, p ¼ 0.0044) and basal metabolic rate (1379.1 74.4 to 1363.9 77.5 kcal, p ¼ 0.0254). Conclusion: These findings suggest that CF root extract has potential as an adjunct therapy for the treatment of obesity. Further studies using double-blind, randomized, placebo-controlled designs are warranted to conclusively demonstrate the effectiveness of CF root extract in personalized supplements and/or pharmacological interventions. Copyright Ó 2013, International Society of Personalized Medicine. Published by Elsevier B.V. All rights reserved.
Keywords: Coleus forskohlii Phytotherapy Forskolin Obesity Ayurveda
1. Introduction Obesity has become one of the major challenges for general public health worldwide. The scarcity of effective therapeutics for obesity demands the development of tailor-made approaches from the viewpoint of personalized medicine. Although there are currently few effective pharmacological treatments for obesity, there is a growing body of literature showing the potential efficacy of botanical medicine and phototherapy as complementary therapy. Several botanicals, including Coleus forskohlii (CF), have been
Abbreviations: CF, Coleus forskohlii; BMI, body mass index; cAMP, cyclic adenosine monophosphate; GI, gastrointestinal. * Corresponding author. Health Science University, Minami-azabu 2-8-12, Nisseibldg. 11fl. DHC, Tokyo 106-0047, Japan. Tel.: þ81 3 5442 3945; fax: þ81 3 5442 3947. E-mail address: [email protected] (S. Kamohara).
considered and tested for the treatment of obesity and for the promotion of healthy weight management. CF is an Indian plant that has been used in traditional Indian medicine, Ayurveda [1,2]. CF belongs to the family Labiatae, also known as the mint family (Fig. 1). The plant is rich in various kinds of alkaloids. The root portion of CF contains forskolin, a biologically active compound [1,2]. Forskolin is a diterpene that acts as an adenylate cyclase activator [3]. Adenylate cyclase is involved in the production of cyclic adenosine monophosphate (cAMP), a significant biochemical agent in metabolic processes. cAMP induces biochemical events that trigger metabolic processes and dietinduced thermogenesis, increase lean body mass, and stimulate the loss of body fat. Consequently, the use of CF extract may be beneficial for maintaining healthy body composition and lean body mass levels. In ovariectomized rats, the administration of CF extract reduced body weight, food intake, and fat accumulation [4]. Several clinical trials have reported an anti-obesity effect for CF extract [5,6].
2186-4950/$ e see front matter Copyright Ó 2013, International Society of Personalized Medicine. Published by Elsevier B.V. All rights reserved. http://dx.doi.org/10.1016/j.pmu.2013.04.003
26
S. Kamohara, S. Noparatanawong / Personalized Medicine Universe 2 (2013) 25e27
2.3. Study drug C. forskohlii (standardized powder extract formulation) was provided to the participants in a tablet form (Forskohlii, DHC Corporation, Tokyo, Japan). One tablet contained 250 mg of CF extract, including 10% forskolin. 2.4. Statistical analysis For statistical analysis, values obtained after the 8-week supplementation period were compared to those at baseline using the Wilcoxon t-test. A p value of less than 0.05 was considered to be statistically significant. 3. Results Twelve subjects (5 men and 7 women, mean age 32.0 2.3 years) completed the study. Significant decreases compared to baseline were detected after 8 weeks for BMI (24.92 0.87 to 23.99 0.86 kg/m2, p ¼ 0.0038), body weight (66.33 3.00 to 63.96 3.10 kg, p ¼ 0.0038), and fat content (29.64 2.19 to 27.77 2.27 kg, p ¼ 0.0038) (Table 1). Lean body mass also significantly decreased (44.34 2.98 to 43.93 3.01 kg, p ¼ 0.0044), as did basal metabolic rate (1379.1 74.4 to 1363.9 77.5 kcal, p ¼ 0.0254). There were no significant differences between baseline and week 8 in terms of systolic and diastolic blood pressure. Three subjects reported abdominal discomfort, such as increased bowel movements, soft stools, and/or diarrhea. No other clinically significant adverse events were detected or noted. 4. Discussion Fig. 1. Botanical aspects of Coleus forskohlii. A. C. forskohlii is an Indian herb, which belongs to the family Labiatae. B. Its root has been used in traditional Indian medicine, Ayurveda.
The purpose of this study was to investigate the efficacy of CF extract for weight-management in Japanese subjects. 2. Methods
C. forskohlii (CF) has been cultivated for the use of its root, and is commonly consumed as part of an ordinary diet in foods such as pickles [1,2]. Its root has also been used in traditional Indian medicine, Ayurveda, for the treatment of cardiovascular diseases, hypertension, abdominal pain, and constipation [2,5,7]. Recently, CF root extract has been widely included as an ingredient of functional foods and dietary supplements used for weight loss and weight management. There were 2 key findings from this study. Firstly, 8 weeks of CF supplementation (500 mg twice a day) promoted weight loss, and
2.1. Subjects and study protocol Eligible volunteer participants were male and female subjects aged 20 years or older without any organ dysfunction who had never experienced psychological and/or chronic diseases. After obtaining informed consent, 15 healthy volunteers participated in an 8-week open-label trial. Subjects received 500 mg of CF extract (10% forskolin) twice a day with their meals. 2.2. Body composition measurements Body composition measurements were taken using a bioelectric impedance analyzer (Tanita Corporation, Tokyo, Japan) on a weekly basis. Body weight (kg), fat content (kg), lean body mass (kg), and basal metabolic rate (kcal) were obtained. Obesity was defined in terms of body mass index (BMI), calculated as body weight divided by the square of height (kg/m2). Lean body mass was the mass of the body excluding fat mass. Adverse events were recorded on a daily basis.
Table 1 Effects of Coleus forskohlii extract on body composition. Baseline BMI Body weight (kg) Fat content (kg) LBM (kg) BMR (kcal) Systolic BP (mmHg) Diastolic BP (mmHg)
4 weeks
8 weeks
p value
24.92 0.87 66.33 3.00
24.26 0.84 64.61 2.99
23.99 0.86 63.96 3.10
p ¼ 0.0038 p ¼ 0.0038
29.64 2.19
28.75 2.20
27.77 2.27
p ¼ 0.0038
44.34 2.98 1379.1 74.4 116 5
44.03 3.02 1367.6 76.0 116 5
43.93 3.01 1363.9 77.5 114 5
p ¼ 0.0044 p ¼ 0.0254 p > 0.05 (n.s)
73 5
74 5
73 4
p > 0.05 (n.s)
N ¼ 12; BMI, body mass index; LBM, lean body mass; BMR, basal metabolic rate; BP, blood pressure; n.s., not significant. Values are represented as mean standard error. The p values indicate the difference between values at baseline and at 8 weeks.
S. Kamohara, S. Noparatanawong / Personalized Medicine Universe 2 (2013) 25e27
secondly, CF supplementation was associated with adverse gastrointestinal (GI) events. Several clinical trials have reported the effects of CF extract on weight loss. An 8-week open-label study in 6 overweight but otherwise healthy women (BMI > 25 kg/m2) who received oral CF extract (containing 50 mg per day of forskolin), found significant reductions in body weight and fat content [5]. In a randomized, double-blind, placebo-controlled 12-week trial, significant weight loss was observed in 30 overweight/obese men after taking CF extract (containing 250 mg per day of forskolin) [8]. A randomized, double-blind, 12-week clinical trial reported that overweight/obese women (BMI 25e35 kg/m2) taking CF extract (containing 50 mg per day of forskolin) experienced weight loss, while the placebo group experienced weight gain. Heart rate, blood pressure, and blood lipid levels were unaffected. No clinically significant side effects were observed [6]. The results of this study were consistent with those of these previous reports, showing effects on weight loss and weight management. In Ayurvedic medicine, it has been reported that CF extract supplementation can lead to mild improvements in systolic and diastolic blood pressure in geriatric subjects with hypertension [7]. Forskolin has also been shown to lower blood pressure in hypertensive rats [1,2]. However, in this study, CF extract had no significant effect on blood pressure. The previous randomized, doubleblind trial in mildly overweight women also found that CF had no effect on blood pressure [6]. These data suggest that CF extract or forskolin may improve hypertension, but have no effect in patients with normal blood pressure. Forskolin, a major constituent of CF extract, activates adenylate cyclase and increases the production of cAMP [9,10]. Increased levels of cAMP induced by forskolin stimulate lipolysis in adipose tissue. Enhanced lipolysis increases fat degradation in the body and may promote weight loss [4]. Traditionally, CF root has been used in Ayurvedic medicine for the treatment of constipation. The contemporary use of CF extract in dietary supplements for weight loss has been anecdotally associated with the side effects of soft stool and diarrhea. In this study, 3 subjects reported mild GI adverse events. We performed a dose escalation study of CF supplementation to assess the frequency and severity of GI adverse events. This 4-week dose escalation study showed that the intake of CF extract was associated with mild GI adverse events, which appeared to be dose-related [11]. The mechanism by which GI events are induced is not fully understood, but one possibility is that cAMP-induced efflux of chloride ions from the intestinal membrane causes GI events such as soft stool and diarrhea. We suggest that a cAMP-dependent chloride channel, known as the cystic fibrosis transmembrane conductance regulator (CFTR), is responsible for the secretion of water into the lumen [12]. Theoretically, increased levels of cAMP in the intestine induced by the intake of CF extract could cause secretion of chloride ions into the lumen via the CFTR. This could result in secretion of water, which manifests as soft stool and diarrhea in subjects who are more susceptible to these effects.
27
5. Conclusion In summary, we showed that the intake of CF extract improved body composition in healthy volunteers. Our findings indicate that CF extract has potential as a complementary therapy in the treatment of obesity. Further studies with double-blind, randomized, placebo-controlled designs are warranted to conclusively demonstrate the effectiveness of CF extract for weight loss and weight management.
Funding This work was supported by a research grant from the DHC Corporation.
Conflict of interest Seika Kamohara is a research advisor for the DHC Corporation laboratory. Somboon Noparatanawong is an employee of the DHC Corporation.
Acknowledgments The authors are grateful to Dr. L. Todd Landreneau for preparing this manuscript.
References [1] de Souza NJ, Dohadwalla AN, Reden J. Forskolin. a labdane diterpenoid with antihypertensive, positive inotropic, platelet aggregation inhibitory, and adenylate cyclase activating properties. Med Res Rev 1983;3:201e19. [2] Premila MS. Ayurvedic herbs: a clinical guide to the healing plants of traditional Indian medicine. New York: Routledge; 2006. [3] Burns TW, Langley PE, Terry BE, et al. Comparative effects of forskolin and isoproterenol on the cyclic AMP content of human adipocytes. Life Sci 1987;40:145e54. [4] Han LK, Morimoto C, Yu RH, et al. Effects of Coleus forskohlii on fat storage in ovariectomized rats. Yakugaku Zasshi 2005;125:449e53. [5] Lieberman SA. A new potential weapon for fighting obesity. Forskolindthe active diterpene in Coleus. Altern Complement Ther 2004;10:330e3. [6] Henderson S, Magu B, Rasmussen C, et al. Effects of Coleus forskohlii supplementation on body composition and hematological profiles in mildly overweight women. J Int Soc Sports Nutr 2005;2:54e62. [7] Jagtap M, Chandola HM, Ravishankar B. Clinical efficacy of Coleus forskohlii (Willd.) Briq. (Makandi) in hypertension of geriatric population. Ayu 2011;32: 59e65. [8] Godard MP, Johnson BA, Richmond SR. Body composition and hormonal adaptations associated with forskolin consumption in overweight and obese men. Obes Res 2005;13:1335e43. [9] Metzger H, Lindner E. The positive inotropic-acting forskolin, a potent adenylate cyclase activator. Arzneimittelforschung 1981;31:1248e50. [10] Ammon HP, Müller AB. Forskolin: from an ayurvedic remedy to a modern agent. Planta Med 1985;51:473e7. [11] Kamohara S, Noparatanawong S. Safety and efficacy of a Coleus forskohlii formulation in healthy volunteers, unpublished results. [12] Thiagarajah JR, Verkman AS. CFTR pharmacology and its role in intestinal fluid secretion. Curr Opin Pharmacol 2003;3:594e9.