Coleus Forskohlii Extract Research Articles

Exploring Acute Liver Damage: Slimming Health Foods and CYP3A4 Induction.

Patients taking multiple drugs and various health foods often develop acute hepatitis. We hypothesized that the interaction between health foods and drug metabolism was the cause of severe liver injury in these patients. Therefore, we studied changes in the activity of the drug-metabolizing enzyme, cytochrome P450 (CYP), using slimming health food extracts and elucidated the molecular mechanism of liver injury onset through hepatotoxicity evaluation. For cytotoxicity testing, health food extract samples were added to HepG2 cells derived from hepatic parenchymal cells and culture medium, and cell viability was calculated 48 h after culture. To evaluate CYP3A4 induction, 3-1-10 cells constructed with a reporter linked to CYP3A4 gene were used, and reporter activity was measured 48 h after culture. In the chronological order of the slimming health food intake history of the patient, niacinamide and Gymnema sylvestre extracts strongly inhibited HepG2 cell viability. In contrast, dietary supplements A and Coleus forskohlii extract strongly induced CYP3A4 reporter activity. Coleus forskohlii extract showed the strongest transcriptional activation of CYP3A4 gene. In a mouse model of human-type drug metabolism, forskolin induced CYP3A4 transcription. Thus, we concluded that CYP3A4 induction by Coleus forskohlii is one of the causes of crucial hepatocellular injury, which is a type of liver injury caused by the active metabolite of acetaminophen produced by CYP3A4.

Evaluation of toxic effects of Coleus forskohlii extract on various body organs of experimental animals-rats

Background: The study aimed observation of pharmacological actions and any adverse effects on various body organs of rats with Coleus forskohlii (CF) extract. Aims and Objectives: The present study was undertaken to evaluate toxic effects of CF extract in experiments animals. Materials and Methods: In the single-dose oral toxicity study, groups of five healthy male and female rats were dosed orally with CF extract at 2000mg/kg BW as per organization of economic cooperation and development guidelines and were observed once daily for 14 consecutive days for toxicity, general behavior, and pharmacological effects. In sub-acute oral toxicity, the test substance was administered for 28 days with daily doses of 200, 400, and 800 mg/kg body weight. In subacute oral toxicity study, groups of five male and five female rats were subjected to 10% forskolin for 28 days. Initially autonomic symptoms (gross behavioral study), followed by hematological, biochemical, and histological parameters, were evaluated. Results: No deaths were reported in all the toxicity studies performed. No significant changes were observed in the hematology and serum biochemistry values from the control group animals. The body weight changes and necropsy results were normal. There was no apparent progression of organ damage in any of these toxicity tests. Furthermore, CF extract did not produce any significant toxic effects in Wistar rats at 2000 mg/kg body weight and had no potential to induce organ damage. Conclusion: The “no observed adverse effect level” of CF extract was determined up to 2000 mg/kg.

Evaluation of Anti-Colorectal Cancer Activity in Methanolic Extract of Coleus forskohlii Root

In a multistage process that involves moving from a precancerous lesion to a malignant tumour state, cancer develops when normal cells undergo the change into tumour cells. Colon cancer, also known as colorectal cancer (CRC), is the third most common and second-deadliest malignant tumour in the world. The current study's objective was to assess the anticancer potential of a methanolic extract of Coleus forskohlii root on the cancer cell line HT-29 using the MTT assay. A variety of assay methods were used, including morphological investigations, cell growth inhibition, and cell viability. At various concentrations (12.5, 25, 50, 100, and 200 µg/ml), the Coleus forskohlii extract was tested against the HT-29 cell line for its ability to inhibit cell proliferation. This study revealed that when concentrations rise the cell growth inhibition levels rise. The conventional medicine Doxorubicin had a growth inhibition of 72.70% at a dose of 5 µg/ml while the lowest growth inhibition was determined to be 9.55% at 12.5 µg/ml and the highest growth inhibition was 71.16% at 200 µg/ml. IC50 was greater than 123.90 µg/ml. According to the study's findings, a human colon adenocarcinoma cell line could be resistant to the anti-colorectal cancer effects of Coleus forskohlii root methanolic extract (HT-29).

Coleus forskohlii and Garcinia indica extracts attenuated lipid accumulation by regulating energy metabolism and modulating gut microbiota in obese mice

Obesity is related to energy imbalance and energy metabolism. In this study, we investigated the anti-obesity effects of Garcinia indica extract (GIE), Coleus forskohlii extract (CFE), and the combinations of these two extracts in a 3T3-L1 cells and high-fat diet (HFD)-induced obese mice. In vitro, GIE showed better effect on TG content than CFE, CFE showed better effect on glycerol released than GIE, and the combinations of GIE and CFE showed both effects compared with GIE and CFE alone. In vivo, GIE, LMIX (0.005% GIE + 0.025% CFE), and HMIX (0.01% GIE + 0.025% CFE) down-regulated adipogenesis-related transcription factors PPARγ and C/EBPα protein expression, CFE promoted lipolysis by up-regulated p-HSL and p-PKA protein expression, and four supplementations promoted fatty acid β-oxidation by up-regulating CPT-1A and PPARα protein expression to decrease lipid accumulation in adipose tissue. Moreover, we found that CFE, LMIX and HMIX, except GIE exert increasing the abundance of Bacteroides caccae compared with HFD group. Overall, GIE, CFE, and the combinations of GIE and CFE were able to decrease body weight and adipocyte size by promoting fatty acid β-oxidation and modulating gut microbiota in HFD-induced obese mice.

<i>Coleus forskohlii</i> Extract Attenuated the Beneficial Effect of Diet-Treatment on NASH in Mouse Model

Obesity is one of the main causes of non-alcoholic steatohepatitis (NASH), which is associated with impaired liver functions including drug metabolism. Coleus forskohlii extract (CFE) is a popular ingredient of weight loss dietary supplements in Japan. In this study, we examined the effect of CFE on the treatment of NASH. C57BL/6 mice (male, 10-wk-old) were fed a NASH diet (high-fat, low-methionine, and choline-deficient diet) for 12 wk to establish NASH. Then, we examined the effect of 0.5% (w/w) CFE in diet during diet-treatment (change to control diet) and/or treadmill-exercise (45 min at 20 m/min, 5 d/wk) to improve NASH for 3 wk. After experimental period, lipids profiles and liver functional markers in the blood, and hepatic lipid content and major CYP subtype mRNA expression and activity in liver were measured. Diet-treatment, but not exercise decreased liver weight and hepatic lipid contents in NASH induced mice. CFE attenuated the effects of diet-treatment which reduced liver weight, even though body weight and adipose tissue weight were reduced. Further, CFE significantly increased liver microsomal CYP1A1, CYP1A2, CYP2C, and CYP3A activities in each condition, and CYP inductions were greater in diet-treatment group compared to those in exercise group. These results suggest that taking CFE should be avoided during diet-treatment of NASH, especially in patients under medication.

Comparison of CYP Induction by Coleus forskohlii Extract and Recovery in the Small Intestine and Liver of Mice.

We examined CYP induction and recovery at various doses of Coleus forskohlii extract (CFE) to assess potential drug interactions by a mechanism involving intestinal CYP. Mice were administered diets with various doses of CFE up to 0.5% (equivalent to 700-800 mg/kg body weight) for 2 weeks, then CFE was withdrawn for 3 d. Changes in CYP activities and mRNA expression in the small intestine and liver were then evaluated. CFE induced CYP in the small intestine at a higher dose compared to the liver; CYP3A was induced at 0.5% and 0.005% CFE in the small intestine and liver, respectively. There was no sex difference in CFE dose for CYP induction. CYP induction quickly reverted after withdrawal of CFE, especially for CYP3A, in the small intestine; whereas, a gradual recovery was observed in the liver. In conclusion, CFE induced CYP in the small intestine and liver; however, a higher dose of CFE was needed for the small intestine. Moreover, the induction was soon recovered, suggesting actual interactions of CFE with prescription drugs are unlikely to occur through CYP in the small intestine.

Investigation the potential role of some medicinal plants extracts in regulating serum lipid profile in female albino rats

Strong evidence showed that many medicinal plants have the potential to reduce hyperlipidemia disease. The aim of this study was to determine the hypolipidemic activity of aqueous extracts of Fucus vesiculosus, Coleus forskohlii, Curcuma longa L., Rosmarinus officinalis L., Camellia sinensis L. and Melissa officinalis L. on lipid profile in serum taken from the blood of rats. Fifty-seven female albino rats were divided into 19 groups, each with three rats, that were treated orally with an aqueous plant extract in three different doses, except the control group which was treated with normal saline only. The chemical compositions of these extracts were analyzed using High Performance Liquid Chromatography (HPLC).The results showed that the dose of 5 mg/kg ofCurcuma longa was the powerful extract which reduced levels of cholesterol (CHO) and low-density lipoprotein (LDL) in serum rats' blood by 31 and 55%, respectively, compared with the control treatment. While, the effective extract to reduce triglycerides (TG) level was that ofFucus vesiculosus(50mg/kg) which reduced TG by 38% compared with the control. Also, Melissa officinalis(50 mg/kg ) extract reduced 30% of very low-density lipoprotein (VLDL) level as compared to the control treatment. In addition, Coleus forskohlii(100 mg/kg) extract increased high-density lipoprotein (HDL) level by 115% after being orally given to rats for four weeks. The results of the study indicated significant differences among the concentrationsof the secondary compoundswithin their extracts, which maybe responsible for the observed variations of hypolipidemic activity for each extract. Based on these results, further investigation should target understanding the mechanismsby which these plants can be used as food additives and as dietary supplement.

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

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.

Identification of Compounds in Coleus forskohlii Extract Involved in the Induction of Hepatic CYP and Fatty Liver in Mice.

Coleus forskohlii extract (CFE), a popular weight-loss herbal product, induces hepatic cytochrome P450 (CYP) and fatty liver in mice; however, its main bioactive ingredient, forskolin, does not show such effects. To ensure the safety of CFE as a dietary supplement, identification of the compounds implicated in the induction of hepatic CYP and fatty liver is required. In this study, we separated a crude CFE extract into 5 fractions (Fr.) by column chromatography and administered the fractions to mice for one week to assess their ability to induce CYP and fatty liver. CYP induction was detected for all fractions, indicating that many compounds may be involved in CYP induction, while fatty liver was only detected for Fr. 2. Further isolation and purification of Fr. 2 by column chromatography identified 14-deoxycoleon U as a major compound and crocetin dialdehyde as a pigment compound. An in vivo mouse study revealed that crocetin dialdehyde had no effect on the liver and, as 14-deoxycoleon U was the major compound in Fr. 2, it is likely that the active compound inducing fatty liver in CFE is 14-deoxycoleon U. These findings will facilitate the preparation of standardized safe CFE ingredients for dietary supplements.

Coleus forskohlii Extract Supplementation in Conjunction with a Hypocaloric Diet Reduces the Risk Factors of Metabolic Syndrome in Overweight and Obese Subjects: A Randomized Controlled Trial.

Limited studies have shown that Coleus forskohlii extract may aid in weight management. This randomized, double blind placebo-controlled clinical study assessed the effects of supplementation with C. forskohlii extract on key markers of obesity and metabolic parameters in overweight and obese individuals. Thirty participants completed the trial and they were randomly assigned to receive either 250 mg of C. forskohlii extract (n = 15) or a placebo twice daily for 12 weeks. All participants were advised to follow a hypocaloric diet throughout the study. Body weight, body mass index (BMI), waist and hip circumference, and waist to hip ratio, were monitored fortnightly. Dietary intake was assessed at the baseline and weeks 4, 8 and 12. Appetite was assessed using visual analogue scales and blood samples were analyzed for plasma lipids, ghrelin, leptin, glucose and insulin at the baseline and end of the intervention. Significant reductions to waist and hip circumference (p = 0.02; p = 0.01, respectively) were recorded in both experimental and placebo groups after the 12 week intervention. Furthermore, high density lipoprotein-cholesterol (HDL-C) was significantly increased (p = 0.01) in both groups. The experimental group showed a favorable improvement in insulin concentration and insulin resistance (p = 0.001; 0.01 respectively) compared to the placebo group. These findings suggest that C. forskohlii extract in conjunction with a hypocaloric diet may be useful in the management of metabolic risk factors.

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 UMI08224.

Extraction and elemental analysis of Coleus forskohlii extract.

Background:Coleus forskohlii Willd. is a popular traditional medicine used since ancient times for treatment of heart diseases, abdominal colic and respiratory disorders.Objective:The aim of this study was to characterize the root extract of the medicinal plant Coleus forskohlii.Materials and Methods:Dry roots of C. forskohlii were used to extract Forskolin using toluene as a solvent. Thus, obtained extract of C. forskohlii was standardized to 30% and used for further studies.Results:The physical properties of the extract were analyzed through scanning electron microscopy analysis, while the characterization of root extract through X-ray diffraction (XRD) and element analysis. The morphological feature of the C. forskohlii extract showed a flake like structure and the XRD showed sulfur trioxide (SO3) and trimer of sulfur trioxide (S3 O9). Through element analysis, elements such as carbon, oxygen, magnesium, aluminum, silicon, phosphorous, and sulfur were identified. Carbon showed the highest weight of 75.49% in comparison to all other elements.

Coleus forskohlii extract attenuates the hypoglycemic effect of tolbutamide in vivo via a hepatic cytochrome P450-mediated mechanism.

This in vivo study in rats evaluated whether Coleus forskohlii extract (CFE) taken orally interacted with tolbutamide, a hypoglycemic drug metabolized by CYP2C enzymes. Rats were fed 0%, 0.3%, 1% (w/w) CFE diet for 2 weeks, followed by 0% CFE diet for 1 day. They were then given 40 mg/kg tolbutamide by intragastric gavage. Blood glucose level was determined up to 6 h after tolbutamide administration. CFE treatment increased total CYP content and various CYP subtypes in the liver. In particular, increases in activity and protein expression were noted for the CYP2B, CYP2C, and CYP3A subtypes. CFE treatment dose-dependently attenuated both the hypoglycemic action of tolbutamide at 6 h and the plasma concentration of tolbutamide. The activity of (S)-warfarin 7-hydroxylase, a CYP2C enzyme was negatively correlated with plasma tolbutamide level, which also showed a negative correlation with the reduction of blood glucose level. These results indicate that CFE induced hepatic CYPs in rats and attenuated the hypoglycemic action of tolbutamide via a hepatic CYP2C-mediated mechanism.

Induction of fatty liver by Coleus forskohlii extract through enhancement of de novo triglyceride synthesis in mice

Coleus forskohlii extract (CFE), an herbal ingredient, is used for weight-loss products. CFE's alleged efficacy is attributed to forskolin. However, CFE has been shown to induce fatty liver in mice, with components other than forskolin playing a part in this effect. The present study addressed the underlying mechanism of CFE-induced fatty liver by analyzing changes in CFE-treated mice of lipid concentrations and of the levels of mRNAs encoding enzymes and transcription factors known to be related to fatty liver. Mice were fed a diet containing 0, 0.3 and 1% CFE for 2 weeks. CFE at 1% clearly induced fatty liver, as demonstrated by histological examination and confirmed by increases in triglyceride concentrations in liver. However, treated mice did not exhibit elevation in plasma levels of non-esterified fatty acids. Comprehensive analysis of liver mRNA levels revealed accumulation of multiple transcripts, including mRNAs encoding enzymes acetyl-CoA carboxylase and long-chain elongase; transcription factor peroxisome proliferator-activated receptor gamma (PPARγ); and lipid-droplet-associated fat-specific protein 27 (Fsp27). These findings suggest that the de novo synthesis and accumulation of triglyceride in the liver, through the enhanced expression of specific lipogenic mRNAs, is a major underlying mechanism of fatty liver induction by CFE.

Effect of Coleus forskohliiextract on cafeteria diet-induced obesity in rats

Background:Obesity is a metabolic disorder that can lead to adverse metabolic effects on blood pressure, cholesterol, triglycerides and insulin resistance and also increases the risk of coronary heart disease, ischemic stroke and type 2 diabetes mellitus. This study was designed to determine the effect of Coleus forskohlii on obesity and associated metabolic changes in rats fed with cafeteria diet.Objective:The aim of this study was to evaluate antiobesogenic and metabolic benefits of C. forskohlii in cafeteria diet induced obesity rat model.Materials and Methods:Rats were randomly divided into five groups of six animals in each group and as follows: Normal pellet diet group; cafeteria diet group; cafeteria diet followed by 50 mg/kg/d Coleus forskohlii extract (CFE), 100 mg/kg/d CFE and 45 mg/kg/d orlistat groups, respectively. Indicators of obesity such as food intake, body weight and alteration in serum lipid profiles were studied.Results:Feeding of cafeteria diet induced obesity in rats. Administration of CFE significantly halted increase in food intake and weight gain associated with cafeteria diet. Development of dyslipidemia was also significantly inhibited.Conclusion:The observed effects validate that supplementation of CFE with cafeteria diet could curb the appetite and mitigate the development of dyslipidemia.

Cyclic AMP synergizes with butyrate in promoting β-defensin 9 expression in chickens

Host defense peptides (HDP) have both microbicidal and immunomodulatory properties. Specific induction of endogenous HDP synthesis has emerged as a novel approach to antimicrobial therapy. Cyclic adenosine monophosphate (cAMP) and butyrate have been implicated in HDP induction in humans. However, the role of cAMP signaling and the possible interactions between cAMP and butyrate in regulating HDP expression in other species remain unknown. Here we report that activation of cAMP signaling induces HDP gene expression in chickens as exemplified by β-defensin 9 (AvBD9). We further showed that, albeit being weak inducers, cAMP agonists synergize strongly with butyrate or butyrate analogs in AvBD9 induction in macrophages and primary jejunal explants. Additionally, oral supplementation of forskolin, an adenylyl cyclase agonist in the form of a Coleus forskohlii extract, was found to induce AvBD9 expression in the crop of chickens. Furthermore, feeding with both forskolin and butyrate showed an obvious synergy in triggering AvBD9 expression in the crop and jejunum of chickens. Surprisingly, inhibition of the MEK-ERK mitogen-activated protein kinase (MAPK) pathway augmented the butyrate-FSK synergy, whereas blocking JNK or p38 MAPK pathway significantly diminished AvBD9 induction in chicken macrophages and jejunal explants in response to butyrate and FSK individually or in combination. Collectively, these results suggest the potential for concomitant use of butyrate and cAMP signaling activators in enhancing HDP expression, innate immunity, and disease resistance in both animals and humans.

A Coleus forskohlii extract improves body composition in healthy volunteers: An open-label trial

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. 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. 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 = 0.0038), body weight (66.33 ± 3.00 to 63.96 ± 3.10 kg, p = 0.0038), fat content (29.64 ± 2.19 to 27.77 ± 2.27 kg, p = 0.0038), lean body mass (44.34 ± 2.98 to 43.93 ± 3.01 kg, p = 0.0044) and basal metabolic rate (1379.1 ± 74.4 to 1363.9 ± 77.5 kcal, p = 0.0254). 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.

Influence of Dietary Macronutrients on Induction of Hepatic Drug Metabolizing Enzymes by Coleus forskohlii Extract in Mice

From studies in mice, we have reported that Coleus forskohlii extract (CFE), a popular herbal weight-loss ingredient, markedly induced hepatic drug metabolizing enzymes, especially cytochrome P450 (CYP), and interacted with co-administered drugs. This study was designed to examine how the induction of drug metabolizing enzymes by CFE was influenced by different levels of macronutrients in the diet. Mice were fed a non-purified diet or semi-purified diet with and without CFE (0.3-0.5%) for 14-18 d, and changes in the ratio of liver weight to body weight, an indicator of hepatic CYP induction, and hepatic drug metabolizing enzymes were analyzed. The ratio of liver weight to body weight, content and activities of CYPs, and activity of glutathione S-transferase were higher in a semi-purified standard diet (AIN93G formula) group than in high sucrose (62.9%) and high fat (29.9%) diet groups. Different levels of protein (7%, 20%, and 33%) in the diets did not influence CFE-induced CYP induction or increase the ratio of liver weight to body weight. The effect of CFE on the ratio of liver weight to body weight was higher with a semi-purified diet than with a non-purified diet, and was similar between dietary administration and intragastric gavage when the CFE dose and the diet were the same. There was a positive correlation between CFE-induced CYP induction and the content of starch in the diets, suggesting that dietary starch potentiates CFE-induced CYP induction in mice. The mechanism of enhanced CYP induction remains unclear.

Hepatic cytochrome P450 mediates interaction between warfarin and Coleus forskohlii extract in vivo and in vitro

This study aimed to determine whether Coleus forskohlii extract (CFE) influences the anticoagulant action of warfarin in mice in vivo and its relationship with hepatic cytochrome P450 (CYP). Mice were fed various doses of CFE standardised with 10% forskolin in a normal diet for one week, or in protein diets containing 7% and 20% casein (low and normal) for four weeks. They were then administered with warfarin by gavage on the last two days of the treatment regimen, and blood coagulation parameters, as well as hepatic CYP, were analysed at 18 h after the last dose. Direct interaction between CFE and forskolin with CYP2C was evaluated in vitro. CFE dose dependently increased hepatic total CYP content and S-warfarin 7-hydroxylase activity at a dietary level of ≥0.05%. Warfarin-induced anticoagulation was attenuated by CFE in parallel with CYP induction. The findings were similar in mice fed diets containing CFE and different ratios of protein. CFE directly inhibited CYP2C activity in mouse and human liver microsomes in vitro, whereas forskolin was only slightly inhibitory. CFE attenuates the anticoagulant action of warfarin by inducing hepatic CYP2C; thus, caution is required with the combination of warfarin and dietary supplements containing CFE.

Effects of Coleus Forskohlii Supplementation on Body Composition and Hematological Profiles in Mildly Overweight Women

PurposeThis study investigated the effects of Coleus Forskohlii (CF) on body composition, and determined the safety and efficacy of supplementation.MethodsIn a double blind and randomized manner, 23 females supplemented their diet with ForsLean™ (250 mg of 10% CF extract, (n = 7) or a placebo [P] (n = 12) two times per day for 12-wks. Body composition (DEXA), body weight, and psychometric instruments were obtained at 0, 4, 8 & 12 weeks of supplementation. Fasting blood samples and dietary records (4-d) were obtained at 0 and 12-wks. Side effects were recorded on a weekly basis. Data were analyzed by repeated measures ANOVA and are presented as mean changes from baseline for the CF and placebo groups, respectively.ResultsNo significant differences were observed in caloric or macronutrient intake. CF tended to mitigate gains in body mass (-0.7 ± 1.8, 1.0 ± 2.5 kg, p = 0.10) and scanned mass (-0.2 ± 1.3, 1.7 ± 2.9 kg, p = 0.08) with no significant differences in fat mass (-0.2 ± 0.7, 1.1 ± 2.3 kg, p = 0.16), fat free mass (-0.1 ± 1.3, 0.6 ± 1.2 kg, p = 0.21), or body fat (-0.2 ± 1.0, 0.4 ± 1.4%, p = 0.40). Subjects in the CF group tended to report less fatigue (p = 0.07), hunger (p = 0.02), and fullness (p = 0.04). No clinically significant interactions were seen in metabolic markers, blood lipids, muscle and liver enzymes, electrolytes, red cells, white cells, hormones (insulin, TSH, T3, and T4), heart rate, blood pressure, or weekly reports of side effects.ConclusionResults suggest that CF does not appear to promote weight loss but may help mitigate weight gain in overweight females with apparently no clinically significant side effects.