{"paper_id":"86d07440-89d6-4024-a412-2bdcaf04cdfa","body_text":"Journal of the International Society of Sports Nutrition. 2(2): 54-62, 2005. (www.sportsnutritionsociety.org) \n \nJournal of the International Society of Sports Nutrition©. A National Library of Congress Indexed Journal. ISSN # 1550-2783  \n \nEffects of Coleus Forskohlii Supplementation on \nBody Composition and Hematological Profiles in \nMildly Overweight Women \n \nShonteh Henderson, Bahrat Magu, Chris Rasmussen, Stacey Lancaster, Chad Kerksick, Penny Smith, \nCharlie Melton, Patty Cowan, Mike Greenwood, Conrad Earnest, Anthony Almada, Pervis Milnor, \nTerri Magrans, Rodney Bowden, Song Ounpraseuth, Ashli Thomas, & Richard B. Kreider \n \nExercise & Sport Nutrition Laboratory, Baylor University, Waco, TX.  Address correspondence to \nRichard_Kreider@baylor.edu\n \n \nReceived August 31, 2005/Accepted November 1, 2005 \n \nABSTRACT \n \nPurpose: This study investigated the effects of Coleus Forskohlii (CF) on body composition, and determined \nthe safety and efficacy of supplementation. Methods: In a double blind and randomized manner, 23 females \nsupplemented their diet with ForsLean™ (250 mg of 10% CF extract, (n=7) or a placebo [P] (n=12) two times \nper day for 12-wks. Body composition (DEXA), body weight, and psychometric instruments were obtained at 0, \n4, 8 & 12 weeks of supplementation. Fasting blood samples and dietary records (4-d) were obtained at 0 and 12-\nwks. Side effects were recorded on a weekly basis. Data were analyzed by repeated measures ANOVA and are \npresented as mean changes from baseline for the CF and placebo groups, respectively. Results: No significant \ndifferences were observed in caloric or macronutrient intake. CF tended to mitigate gains in body mass (-\n0.7±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 \nfat 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, \n0.4±1.4 %, p=0.40). Subjects in the CF group tended to report less fatigue (p=0.07), hunger (p=0.02), and \nfullness (p=0.04). No clinically significant interactions were seen in metabolic markers, blood lipids, muscle \nand liver enzymes, electrolytes, red cells, white cells, hormones (insulin, TSH, T3, and T4), heart rate, blood \npressure, or weekly reports of side effects. Conclusion: Results suggest that CF does not appear to promote \nweight loss but may help mitigate weight gain in overweight females with apparently no clinically significant \nside effects.  Journal of the International Society of Sports Nutrition.  2(2):54-62, 2005 \n \nKey Words: Weight Management, Nutritional Supplement, Lipolysis, Obesity, Herbs \n \n \nINTRODUCTION \n \nColeus forskohlii  ( C F )  i s  a  p l a n t  n a t i v e  t o  I n d i a .  \nSince ancient times, plants of the Coleus species have \nbeen used as an herbal medicine to treat various \ndisorders of the cardiovascular, respiratory, \ngastrointestinal, and central nervous systems (1). \nForskolin has been isolated from the roots of the \nIndia-based Coleus Forskohlii . One of the most \ncommon species that contains forskolin is Coleus \nForskohlii Briq. Coleus forskohlii  Briq. belongs to \nthe family Labiatae, better known as the mint family. \nChemically, it is a plant rich in alkaloids, which are \nconsidered to have a high probability of influence on \nthe biological systems (2).   \n \nForskolin is a diterpene that acts directly on \nadenylate cyclase (3). Adenylate Cyclase is an \nenzyme that activates Cyclic Adenosine \nMonophosphate, or Cyclic AMP (cAMP) in the cell. \nCyclic AMP promotes the breakdown of stored fats \nin animal and human fat cells (4). It regulates the \nbody’s thermogenic response to food, increases the \nbody’s basal metabolic rate, and increases utilization \nof body fat. It may also release fatty acids from \nadipose tissue, which results in increased \nthermogenesis, loss of body fat, and theoretically \nincreased lean body mass (5). Forskolin increases \ncAMP accumulation, and therefore stimulates \nlipolysis. So, with high concentrations of forskolin, \ncAMP and lipolysis increase (4). Enhanced lipolysis \nincreases fat degradation and fat usage as a fuel in the \nbody (3). This may promote fat and weight loss.  It is \nthought that supplementing with forskolin may \nenhance fat loss without loss of muscle mass (6-8). \n\n 55\nA previous proof-of-concept preliminary study was \nconducted to test the effects of CF on body \ncomposition (5).  The study used a population of six \noverweight, but otherwise healthy, women (BMI > \n25) who ingested forskolin twice daily for eight \nweeks. Each subject maintained her previous daily \nphysical exercise and eating habits. The results of the \nstudy showed a significant decrease in the mean \nvalues for body weight and fat content using \nbioelectrical impedance (BIA) methodology. Lean \nbody mass significantly increased compared to \nbaseline. No side effects were reported.  This \npreliminary study showed that, given 25 mg of \nforskolin twice a day, overall body weight could \nimprove by increasing lean body mass and by \ndecreasing weight from body fat (5). \n \nA recent study conducted by Godard and colleagues \n(6) evaluated the effects of forskolin supplementation \n(250 mg of a 10% CF extract taken twice a day for \n12-weeks) in overweight and obese men (BMI > 26) \non body composition, testosterone, metabolic rate, \nand blood pressure.  The study consisted of thirty \nparticipants randomized, in a double-blind, placebo-\ncontrolled (forskolin n = 15, placebo n = 15) manner \nfor 12 weeks.  Body composition determined by \nDEXA was affected due to significant decreases in \nfat percentage and fat mass when compared to the \nplacebo group (p ≤ 0.05).  Bone mass changes \noccurred in the forskolin group (p ≤ 0.05) when \ncompared to the placebo group.  The results of lean \nbody mass revealed an increased trend when \ncompared to the placebo group (p = 0.097).  In \naddition, increases in serum free testosterone \noccurred in the forskolin  group compared to the \nplacebo group (p ≤ 0.05).    This study showed that \nbody composition decreased, bone mass increased, \nand serum free testosterone increased.  Thus, it was \nconcluded that forskolin use could possibly be used \nas a therapeutic agent for weight management and \ntreatment in obese men (6). \n \nThe present study was needed to further investigate \nthe effectiveness of CF.  Aside from its potential \nhealth and therapeutic benefits, additional research \nwas needed to assess its role in the management of \nbody composition, and to determine the safety and \nefficacy of supplementation. It was also of interest to \nthe investigator how forskolin affects general \nmarkers of health (i.e. heart rate, blood pressure, and \nblood variables). This  study took a more \ncomprehensive approach to explore the role that \nforskolin supplementation has on body composition, \nfat loss, and general markers of health.  \n \n \nMETHODS AND MATERIALS \n \nSubjects. Nineteen (19) moderately overweight (BMI \nof 25 - 35) female subjects between the ages of 18 \nand 40 participated in the study. An initial \nentry/familiarization session was held during which \nsubjects completed personal and medical histories, \nand signed Informed Consent Statements. A general \nmedical exam was given that included evaluating the \nmedical history, performing a general physical \nexamination, and evaluating whether the subjects met \nentry criteria to participate in the study. Entry criteria \nwere based on age, BMI, and the presence of any \nmedical condition deemed unsuitable for \nparticipation by the examining physician. Table 1 \npresents the experimental protocol/testing schedule \nthat was conducted. \n \nTable 1. Overview of Research Design \n \nEntry  \n \nBaseline 0 \nweek (T1) \n4 week \n(T2) \n8 week \n(T3) \n12 week \n(T4) \n \nPhone \ninterview  \n \nFamiliarization \nsession  \n \nGeneral \nmedical exam \nby a registered \nnurse to \ndetermine \nqualifications \nto participate \nin study. \n \n \nBlood \nCollection \n    * Clinical   \n        Chemistry \n * Thyroid \nPanel \n * Fasting \nInsulin  \nTotal Body \nWater \nDEXA Body \nComp \nHR/Blood \nPressure \nDietary \nHistory \nQuestionnaires \n \n \nTotal Body \nWater \nDEXA Body    \n   Comp \nHR/Blood  \n   Pressure \nQuestionnaires \n \n \n \nTotal Body \nWater \nDEXA Body \nComp \nHR/Blood \nPressure \nQuestionnaires \n \n \n \nGeneral \nMedical Exam \nBlood \nCollection \n * Clinical  \n      Chemistry \n *Thyroid \nPanel \n * Fasting \nInsulin  \nTotal Body \nWater \nDEXA Body \nComp \nHR/Blood \nPressure \nDietary \nHistory \nQuestionnaires \n \n \n \nPre-Supplementation / Baseline Testing.  Subjects \nrecorded all food intake on dietary record forms for \nfour days (4-d) prior to pre-supplementation testing.  \nSubjects were instructed to refrain from exercise for \n48 hours and to fast for 8 hours prior to pre-\nsupplementation testing. Subjects then reported for \nthe initial battery of assessments, which included an \nappetite questionnaire, a psychological mood \ninventory, and the following measurements: body \nweight, total body water, body composition, resting \nheart rate, and blood pressure.  Subjects then donated \napproximately 30 milliliters (6 teaspoons) of blood. \n \nSupplementation Protocol . After baseline testing, \nsubjects were randomly and blindly assigned to \ningest Forslean™ or a matched placebo for 12 weeks. \nThe Forslean™ forskolin extract and appropriate \nplacebo were prepared by Sabinsa Corporation \n(Piscataway, NJ)\n. Capsules were provided in a 2-\npiece hard shell capsule form, and delivered in \nblindly labeled bottles containing 60 capsules each. \n\n 56\nEach capsule contained 250 mg of the extract \nstandardized for 10% forskolin, or a suitable placebo.  \nParticipants were instructed to take one capsule in the \nmorning and one in the evening, a half an hour before \na meal for 12 weeks.  \n \nPost-Supplementation Assessments . Subjects were \ninstructed to provide weekly reports to the research \nnurse in order to monitor safety and side effects. \nSubjects who did not provide a weekly report were \ncalled by the research nurse to determine whether \nthey had experienced any unexpected problems \nand/or adverse events.  Following 4 and 8 weeks of \nsupplementation, subjects returned to have the same \ninitial battery of assessme nts performed minus the \nblood draw and dietary history.  After 12 weeks of \nsupplementation, subjects returned to repeat all \nbaseline tests (including dietary history and blood \ndraw).   \n \nPROCEDURES \n \nMedical Monitoring. Subjects who met eligibility  \ncriteria were informed to report any unexpected \nproblems or adverse events they encountered during \nthe course of the study. The subjects were contacted \non a weekly basis to determine if they experienced \nany unexpected problems and/or adverse events. If \nclinically significant side effects were reported, the \nsubjects were to discuss the problem with the \nsupervising physician to determine whether any \nmedical treatment was needed and/or whether the \nsubject could continue in the study. If so, the subject \nwould be referred to obtain medical treatment from \nhis/her personal physician.  New findings and/or \nmedical referrals of unexp ected problems and/or \nadverse events would be documented, placed in the \nsubjects research file, and reported to the University \nof Memphis IRB committee. \n \nDietary Inventories . Subjects recorded all food and \nfluid intake on dietary record forms.  Dietary intake \nwas assessed using the Food Processor III Nutrition \nSoftware (Version 7.5) (Salem, OR). \n \nAppetite Scale. Appetite was assessed using a visual \nanalogue scale ranging from low to high (9). This \nscale was used to record appetite, hunger,  fullness, \nsatisfaction, energy, and quality of food.  \n \nPsychometric Inventory .  Mood changes were \nassessed by the Profile of Moods States (POMS) \ninventory ( San Diego, CA ) .   T h e  P O M S  i s  a  \nvalidated, standardized self-rating scale consisting of \n57 items that measures six identifiable mood states; \nTension-Anxiety; Depression-Dejection; Anger-\nHostility; Vigor-Activity; Fatigue-Inertia;\n Confusion-\nBewilderment.  A 5-point scale is used from 0 = not \nat all to 4 = extremely (10). \n \nTotal Body Weight.  Prior to each assessment, height \nwas measured with the shoes removed using standard \nanthropometrics. Total body weight was also \nmeasured with the shoes removed using a calibrated \nelectronic scale with a precision of +/-0.02 kg \n(Healthometer, Bridgeview, IL ). The scale was \ncalibrated by placing cer tified 25-kg weights and \nbalancing the scale. \n \nTotal Body Water . Total body water was estimated \nusing the Valhalla Scientific Bioelectrical Impedance \nAnalyzer ( Model 1990B, San Diego, CA ), which \nmeasures bio-resistance of water and body tissues \nbased on a minute low-energy, high frequency \ntransmitted through the body. The analyzer was \ncalibrated internally to a st andard electrical current \nby pressing the calibration key located on the unit. \nAfter calibration was completed, subjects were \nplaced in a supine position with the arms slightly bent \nat the elbows and palms facing down. The arms and \nhands were not to contact the body, and the legs were \nnot allowed to touch each other. The subjects were \ninstructed to remove the right shoe and sock. The \nlaboratory technician sterilized the area where the \nelectrodes were to be placed with a Kendall \nWebcol™ alcohol prep saturated with 70% isopropyl \nalcohol. Electrodes were placed on the posterior \naspect of the hand and wrist, and on the anterior \naspect of the foot and ankle.  \n \nBody Composition & Bone Density .  Body \ncomposition was determined using a calibrated \nHologic 4500W dual-energy x-ray absorptiometry \n(Bedford, MA ) with the Hologic version V7, Rev F \nsoftware ( Waltham, MA ).  The dual-energy x-ray \nabsorptiometry (DEXA) segments regions of the \nbody (right arm, left arm, trunk, right leg, and left \nleg) into three compartments for determination of fat, \nsoft tissue (muscle), and bone mass. The scanned \nbone, fat, and fat-free/soft tissue mass for each region \nwere subtotaled to determine whole body values. \nPercent body fat was calculated by dividing the \namount of measured fat mass by total scanned mass. \nDay–to-day reliability studies of hip, spine, and \nwhole body scans on men and women show the \nDEXA used in this study to be a highly reliable and \nprecise method for determining variations in body \ncomposition segments (11). Test-retest reliability \nstudies performed on male and athletes with this \nDEXA machine yielded a mean deviation for total \nBMC and total fat free/soft tissue mass of 0.31% with \na mean intra-class correlation of 0.985 (11). Quality \n\n 57\ncontrol (QC) calibration pr ocedures were performed \non a spine phantom ( Hologic X-CALIBER Model \nDPA/QPR-1 anthropometric spine phantom ) prior to \neach testing session. In addition, weekly calibration \nprocedures were performed on a density step \ncalibration phantom. Testing was performed by \ncertified radiology technicians who properly \npositioned the subjects in a supine manner on the \nDEXA table and executed testing according to \nstandard procedures.  \n \nHeart Rate & Blood Pressure .  Heart rate was \ndetermined by palpitation of the radial artery \naccording to procedures outlined in the ACSM’s \nGuidelines for Exercise Testing and Prescription  \n(12).  Blood pressure was assessed in the supine \nposition after resting for 5-min with a mercurial \nsphygmomanometer ( Trimline by PyMah \nCorporation, Somerville, NJ ) using standard \nprocedures.   \n \nBlood Samples. Subjects observed an overnight eight \n(8) hour fast prior to reporting to the lab to donate \nblood. Approximately 6 teaspoons of venous blood \n(30 milliliters) were obtained through venipuncture \nof an antecubital vein in the forearm using standard \nphlebotomy procedures. Samples were collected into \none (1) 10 mL Vacutainer SST™ gel and clot \nactivator tube, and two (2 ) 5mL Vacutainer Brand K\n3 \nEDTA™ sterile interior tu bes. Trained laboratory \ntechnicians centrifuged the blood samples at 5000 rev \nx min\n-1 for 10 minutes in a Biofuge 17R Centrifuge \n(Heraeus Inc., Germany ). Serum from one SST tube \nwas transferred into Costar microcentrifuge tubes \n(Corning Incorporated, Corning, NY ) using plastic \ndisposable Falcon™ transfer pipets ( Becton \nDickinson) and frozen at -80º Celsius for subsequent \nanalysis. Serum from the remaining SST and EDTA \ntubes were transferred into  two (2) separate 10 mL \nplain sterile tubes. The whole blood was diluted with \n2 mL of saline solution. Both serum and whole blood \nsamples were refrigerated and sent to Quest \nDiagnostic Labs ( Ann Arbor, MI)  for clinical \nanalysis.  \n \nA complete 31-panel clinical chemistry profile was \nrun on serum samples using the Technicon DAX \nmodel 96-0147 automated chemistry analyzer \n(Technicon Inc., Terry Town, NY ) following standard \nclinical procedures. This panel consisted of muscle \nenzymes [creatine kinase, phosphorus, calcium]; liver \nenzymes [direct bilirubin, total bilirubin, gamma \nglutamyl transferase (GGT), lactate dehydrogenase \n(LDH), alkaline phosphatase, AST (SGOT), ALT \n(SGPT)]; lipid profile [triglycerides, total cholesterol, \nhigh-density lipoprotein-cholesterol (HDL-C), low-\ndensity lipoprotein-cho lesterol (LDL-C), \ncholesterol/HDLC ratio, glucose], electrolytes \n[sodium, potassium, chloride, carbon dioxide, urea \nnitrogen (BUN), creatinine, BUN/creatinine ratio], \nprotein status [uric acid, total protein, albumin, \nglobulin, albumin/globulin ratio], and whole blood \ncell counts [hemoglobin, hematocrit, red blood cell \ncounts, white blood cell counts (basophils, absolute \nbasophils, eosinophils, absolute eosinophils, \nmonocytes, absolute monocytes, lymphocytes, \nabsolute lymphocytes, neutrophils, absolute \nneutrophils), platelet count, mean corpuscular volume \n(MCV), mean corpuscular hemoglobin (MCH), mean \ncorpuscular hemoglobin co ncentration (MCHC), red \ncell distribution width (RDW)]. Cell counts with \npercent differentials were run on whole blood \nsamples using a Coulter STKS automated analyzer \n(Coulter Inc., Hialeah, FL ) using standard \nprocedures.   \n \nFrozen serum samples were sent to the Department of \nPhysiology at East Tennessee State University to \nassay thyroid stimulating hormone (thyrotropin), \nthyroxin, total thyroxin, and fasting insulin. A \nchemistry profile was run on these samples using an \nImmulite Mark 5 HSS ch emiluminescence random \naccess immunoassay analyzer ( Diagnostic Products \nCorporation, Los Angeles, CA ) following standard \nprocedures. These analyzers were calibrated daily to \ncontrols according to manufacturer recommendations \nand federal guidelines for clinical diagnostic \nlaboratories. Test to test reliability of performing \nthese assays ranged from 2 to 6% for individual \nassays with a average variation of ±3%. Samples \nwere run in duplicate to verify results if the observed \nvalues were outside contro l values and/or clinical \nnorms according to standard procedures (13). \nAnalysis of these blood parameters helped determine \nthe safety effects of this nutritional supplementation \nformulation on general markers of clinical health \nstatus and selected hormones.   \n \nDATA ANALYSIS \n \nA 2 (groups) x 4 (times) analysis of variance \n(ANOVA) test with repeated measures on the second \nfactor was performed on five variables: total body \nweight, total body water, body composition, appetite \nsurveys, and psychological mood state inventories. A \n2 X 2 ANOVA test with repeated measures on the \nsecond factor was performed on the diet logs and the \nclinical profiles for the blood samples. Type I error \nwas controlled at 0.05 for all of the data analysis  \n \n\n 58\nTable 2.  Four-day total dietary intake for the CF and P groups.   \nVariable Group Week 0 \n(T1) \nWeek 8 \n(T3) \nWeek 12 \n(T4) Significance \nFat \n(g/kg/d) \nCF \nP \n281.5±87.5 \n337.0±124.2 \n243.2±69.0 \n310.1±99.1 \n187.0±55.8 \n219.0±86.3 \nGroup \nTime \nGroup x Time \n0.153 \n0.002 \n0.696 \nCarbohydrates \n(g/kg/d) \nCF \nP \n959.1±278.7 \n959.7±253.6 \n903.5±227.9 \n953.3±269.2 \n777.5±303.2 \n831.5±184.1 \nGroup \nTime \nGroup x Time \n0.719 \n0.025 \n0.676 \nProtein \n(g/kg/d) \nCF \nP \n293.8±112.0 \n318.5±143.5 \n270.8±93.0 \n290.7±129.9 \n242.8±80.7 \n282.1±77.6 \nGroup \nTime \nGroup x Time \n0.525 \n0.213 \n0.831 \nEnergy Intake \n(kcal/kg/d) \nCF \nP \n7458±1920 \n8087±2310 \n6833±1259 \n7772±2165 \n5690±1927 \n6435±1475 \nGroup \nTime \nGroup x Time \n0.299 \n0.007 \n0.919 \n \n \nTable 3.  Selected hematological markers for the CF and P groups.   \nVariable Group Week 0 \n(T1) \nWeek 12 \n(T4) Significance \nWhite Blood  \nCells \n(thous/cum) \nCF \nP \n6.5±1.8 \n5.9±1.7 \n7.9±2.3 \n5.1±1.7 \nGroup \nTime \nGroup x Time \n0.030 \n0.366 \n0.007 \nAbsolute \nLymphocytes \n(cells/mcl) \nCF \nP \n2161.2±433.6 \n2084.4±511.4 \n2771.0±643.2 \n1945.8±447.5 \nGroup \nTime \nGroup x Time \n0.051 \n0.043 \n0.003 \nCalcium \n(mg/dl) \nCF \nP \n9.1±0.1 \n9.3±0.2 \n9.3±0.4 \n9.1±0.2 \nGroup \nTime \nGroup x Time \n0.894 \n0.904 \n0.030 \nALT (SGPT) \n(U/L) \nCF \nP \n11.8±4.6 \n22.5±10.1 \n11.4±3.4 \n22.0±13.8 \nGroup \nTime \nGroup x Time \n0.020 \n0.036 \n0.000 \nUric Acid \n(mg/dl) \nCF \nP \n4.2±0.9 \n3.9±1.1 \n3.8±1.0 \n4.4±1.4 \nGroup \nTime \nGroup x Time \n0.006 \n0.724 \n0.003 \nAbsolute \nNeutrophils \n(cells/mcl) \nCF \nP \n3791.9 ±1273.0 \n3270.7±1251.3 \n4467.7±\n1737.2 \n2732.5±596.0 \nGroup \nTime \nGroup x Time \n0.042 \n0.787 \n0.027 \n \n \nprocedures. Tukey least significant difference (LSD) \npost-hoc procedures were conducted when a \nsignificance level was observed. Delta values were \ncalculated on body composition variables to further \nhighlight significant changes that occurred during the \nstudy. \n \nRESULTS \n \nNutritional Intake . Table 2 presents four day total \nnutritional intake data for the CF and P groups.  No \nsignificant group interactions ( p>0.05) were \nobserved in mean relative daily energy intake,  \ncarbohydrate intake, protein intake, or fat intake. \nHowever, daily intake for the energy, carbohydrate,  \n \nand fat variables significantly decreased ( p < 0.05 ) \nfrom Week 0 to Week 12. \n \nMedical Safety Analysis. Table 3 presents significant \nblood markers obtained throughout the study.  These \nhematological responses were measured for the \nanalysis of the safety of the supplement on general \nmarkers of health. The results of the analysis \nindicated a significant group interaction in white \nblood cell levels ( p=0.007), absolute lymphocyte \nlevels ( p=0.003), absolute neutrophils ( p = 0. 027), \ncalcium levels ( p=0.03), ALT ( p=0.000), and uric \nacid ( p=0.003) for the CF group. Additionally, a \nsignificant group effect ( p < 0.05 ) was observed in \nred blood cell count, % hematocrit, MCV, MCH,  \n\n 59\nTable 4. Body composition and bone density values for the CF and P groups \nVariable Group Week 0 \n(T1) \nWeek 4 \n(T2) \nWeek 8 \n(T3) \nWeek 12 \n(T4) Significance \nBody \nWeight \n(kg)  \nCF \nP \n87.2±12.4 \n86.1±12.5 \n86.8±12.1 \n86.1±15.3 \n86.5±12.8 \n87.1±14.3 \n86.6±13.0 \n87.4±13.4 \nGroup \nTime \nGroup x Time \n0.987 \n0.492 \n0.121 \nBone \nMineral \nArea \n(cm\n2) \nCF \nP \n1772±94 \n1846±116 \n1772±121 \n1861±110 \n1755±127 \n1855±106 \n1781±130 \n1844±120 \nGroup \nTime \nGroup x Time \n0.148 \n0.929 \n0.756 \nBone \nMineral \nContent \n(g) \nCF \nP \n1781±202 \n1872±237 \n1788±206 \n1874±223 \n1759±226 \n1874±232 \n1803±223 \n1870±242 \nGroup \nTime \nGroup x Time \n0.412 \n0.663 \n0.601 \nBone \nMineral \nDensity  \n(g/cm\n2 ) \nCF \nP \n1.0±0.08 \n1.0±0.08 \n1.0±0.07 \n1.0±0.07 \n0.9±0.07 \n1.0±0.08 \n1.0±0.07 \n1.0±0.08 \nGroup \nTime \nGroup x Time \n0.923 \n0.367 \n0.578 \nFat Mass  \n(kg) \nCF \nP \n33.82±8.00 \n31.27±7.22 \n33.77±8.38 \n31.69±7.94 \n33.66±8.17 \n32.20±8.70 \n33.61±8.37 \n32.36±8.22 \nGroup \nTime \nGroup x Time \n0.638 \n0.336 \n0.161 \nLean Mass \n(kg) \nCF \nP \n44.65±5.75 \n46.40±6.18 \n44.40±4.88 \n46.47±6.45 \n44.69±5.44 \n47.01±5.97 \n44.59±5.53 \n47.05±5.62 \nGroup \nTime \nGroup x Time \n0.446 \n0.168 \n0.212 \nLean + \nBMC \n(kg) \nCF \nP \n46.43±5.88 \n48.27±6.36 \n46.18±5.01 \n48.35±6.63 \n46.45±5.57 \n48.88±6.16 \n46.40±5.66 \n48.92±5.81 \nGroup \nTime \nGroup x Time \n0.440 \n0.154 \n0.211 \nTotal Mass \n(kg) \nCF \nP \n80.25±12.42 \n79.54±12.70 \n79.96±11.93 \n80.04±13.60 \n80.11±12.59 \n81.08±13.81 \n80.017±12.7 \n81.28±13.01 \nGroup \nTime \nGroup x Time \n0.948 \n0.139 \n0.080 \nBody Fat  \n(%) \nCF \nP \n41.8±4.7 \n39.0±3.7 \n41.8±5.0 \n39.5±4.0 \n41.6±4.4 \n39.2±4.6 \n41.6±4.8 \n39.3±4.3 \nGroup \nTime \nGroup x Time \n0.243 \n0.923 \n0.395 \nBody \nWater \n(%) \nCF \nP \n43.9±4.0 \n46.1±3.2 \n44.1±3.6 \n46.1±3.6 \n45.5±3.8 \n46.1±3.2 \n45.3±4.3 \n47.3±5.2 \nGroup \nTime \nGroup x Time \n0.289 \n0.200 \n0.802 \n \n \ntotal bilirubin, glucose, BUN/creatinine ratio, and \ncholesterol/HDL ratio within the P and CF groups. A \nsignificant decrease was noted in all of the values \nexcept for total bilirubin, which significantly \nincreased within both groups. The cholesterol/HDL \nratio also significantly increased within the P group.  \n \nThere was a significant time effect ( p < 0. 05) in \nhemoglobin levels, glucose, albumin levels, red cell \ndimension width, and creatine kinase from Week 0 to \nWeek 12. No significant group interactions ( p>0.05) \nwere observed in the blood lipid profile, \nhemodynamic, hormone, insulin variables, or weekly \nreports of side effects.  All values remained within \nnormal clinical parameters.  \n \nBody Composition . Table 4 presents body \ncomposition data obtained during each of the four \ntesting trials, and Figure 1 presents mean changes in  \n \nbody composition data from Week 0 to Week 12. \nThere were no significant differences ( p>0.05) in \nbody weight , bone mineral area, bone mineral \ndensity, fat mass, lean mass, % body fat, or % body \nwater observed between the two groups. In addition, \nthere was no significant interaction (p>0.05) amongst \nthe groups in body composition. Group trends \noccurred in total mass (p=0.08). \n \nPsychological Profiles. A significant time effect was \nnoted for tension/anxiety ( p = 0. 006) in the \npsychological analysis of mood. Group trends \noccurred in fatigue ( p = 0.07 ) between P and CF \nfrom Week 0 to Week 12. No other significant \ndifferences were observed. \n \nAppetite Profiles . Table 5 presents the appetite data \nobtained during each of the four testing trials. There \nwere no significant changes observed in appetite,  \n\n 60\n-1000\n-500\n0\n500\n1000\n1500\n2000\n2500\n3000\n1234\nTrials (Weeks)\nFat (g)\n-2\n-1.5\n-1\n-0.5\n0\n0.5\n1\n1.5\n2\n1234\nTrials (weeks)\n% Body Fat\n \n \n \n \n \n \n \n \n \n \n \n \n \n \nFigure 1. The upper left panel depicts changes in DEXA total scanned mass (g), the upper right panel illustrates changes in DEXA fat-\nfree mass (g), the lower left panel highlights differences in DEXA lean mass (g), and the lower right panel shows changes in DEXA % \nbody fat from Week 0 to Week 12 for CF (♦) and P (■). \n \n \namount of energy, or over all quality of food. The \nanalysis indicated a significant time effect ( p = \n0.026) in satisfaction from food in both groups from \nWeek 0 to Week 12. There was a significant decrease \nobserved in the feelings of fullness variable ( p = \n0.04) for group CF from Week 0 to Week 12.  \n \nDISCUSSION \n \nThe major findings of this study were: 1.) 12-weeks \nof CF supplementation (250 mg of a 10% CF extract \ntaken two times per day) did not promote weight loss \nbut may have helped mitigate weight gain in free-\nliving overweight females; and, 2.) CF \nsupplementation did not adversely affect markers of \nhealth status.  However, some interesting findings \nwere observed that warrant additional research.  The  \nfollowing discusses the results of this study in greater \ndetail.  \n \nDietary Intake . The subjects involved in the study \nrecorded all food and fluid intake during Week 0 and \nWeek 12 of the testing sessions. Significant decreases \nwere seen in carbohydrate, fat, and energy intake for \nboth groups over time. No significant differences \nwere observed between CF and P, which suggest that \nsupplementation had no significant effect on diet.  \n \nThe changes over time could reflect subject efforts to \ndecrease food intake in an attempt to assist in the \nweight loss process. It is possible that more group \ndifferences could have been observed if a specific \ndiet were implemented into the study. This would \nallow for the effects of supplementation to be more \nclosely monitored.  \n \nMedical Safety Analysis . One purpose of this study \nwas to determine the safety effects of forskolin \nsupplementation on general markers of health. This \nwas measured by monitoring changes in heart rate \nand blood pressure taken during each testing session, \nand serum and whole blood samples collected during \nWeek 0 and Week 12 of the study.   Previous \nresearch indicated that CF causes an increase in heart \nrate and a decrease in blood pressure (14-15). \nHowever, the results of this analysis showed that \nsupplementation had no significant effect on either \nvariable. The blood samples collected were assayed \nfor muscle and liver en zymes, lipid profile, \nelectrolytes, protein status, thyroid hormones, fasting \ninsulin, and whole blood cell counts. Significant \nchanges were observed from Week 0 to Week 12 in \nGroup CF in white blood cell count, absolute \nlymphocyte count, absolute neutrophil count, calcium \nlevels, ALT, and uric acid levels. Supplementation  \n-1 000\n-500\n0\n500\n10 0 0\n150 0\n2000\n2500\n3000\n12 34\nT rials (Weeks)\nTotal Mass (g)\n-1500\n-1000\n-500\n0\n500\n1000\n1500\n1234\nTrials (Weeks)\nFat Free Mass (g)\n\n 61\nTable 5.  Appetite markers for the CF and P groups. \nVariable Group Week 0 \n(T1) \nWeek 4 \n(T2) \nWeek 8 \n(T3) \nWeek 12 \n(T4) Significance \nAppetite CF \nP \n4.8±0.3 \n5.1±0.8 \n4.7±1.4 \n4.1±1.6 \n4.4±1.1 \n4.3±1.4 \n4.5±0.7 \n5.1±1.1 \nGroup \nTime \nGroup x Time \n0.829 \n0.673 \n0.581 \nHunger CF \nP \n4.0±1.2 \n4.9±1.1 \n3.8±1.0 \n4.0±1.5 \n4.0±1.8 \n4.1±1.1 \n3.1±1.5 \n5.2±1.0 \nGroup \nTime \nGroup x Time \n0.054 \n0.645 \n0.165 \nSatisfaction \nfrom Food \nCF \nP \n5.8±1.7 \n6.1±1.4 \n5.0±0.5 \n5.9±1.3 \n4.4±1.2 \n5.5±1.9 \n4.7±1.9 \n5.8±1.1 \nGroup \nTime \nGroup x Time \n0.138 \n0.026 \n0.242 \nFeeling of \nFullness \nCF \nP \n5.8±1.3 \n6.3±1.3 \n4.7±0.9 \n5.9±1.7 \n5.0±2.1 \n6.1±1.8 \n4.1±1.3 \n6.4±1.5 \nGroup \nTime \nGroup x Time \n0.040 \n0.086 \n0.042 \nAmount of \nEnergy \nCF \nP \n5.9±2.0 \n5.8±1.2 \n5.2±1.3 \n6.0±1.2 \n5.5±2.5 \n5.9±1.4 \n5.5±1.9 \n5.8±1.7 \nGroup \nTime \nGroup x Time \n0.611 \n0.781 \n0.785 \nOverall \nQuality of \nFood \nCF \nP \n4.8±1.5 \n5.2±1.4 \n5.1±1.8 \n5.7±1.0 \n4.5±1.1 \n5.6±1.3 \n4.0±1.7 \n5.6±1.4 \nGroup \nTime \nGroup x Time \n0.102 \n0.472 \n0.134 \n \n \nresulted in an increase in calcium, white blood cell, \nabsolute lymphocyte, and absolute neutrophil counts. \nDecreases were observed in ALT and uric acid levels. \nThese variables contribute to muscle, immune, liver, \nand protein functions, respectively, in the body. Even \nthough these changes occurred, the values remained \nwithin normal ranges and were relatively small.  \nAdditionally, no significan t adverse events were \nreported during the study that could be attributed to \nthe supplementation protocol.  Therefore, these \nfindings suggest that CF supplementation does not \nappear to be associated with any significant clinical \nside effects. \n \nBody Composition . This study was also conducted \nwith the purpose of investigating the effectiveness of \nCF on the management of body composition.  Body \ncomposition was analyzed by examining measures of \nbody weight, body water, and bone density. Previous \nresearch suggests that forskolin is associated with \nincreased lipolysis, which would increase fat and \nweight loss in the body (13). The findings from the \nprevious pilot study suggested that supplementation \nsignificantly decreases body weight and fat, and \nsignificantly increases lean body mass in free living \nsubjects (5).  The results from this study did not \nreplicate those findings.  Additionally, results \ncontrast recent findings by Godard and colleagues (6) \nwho reported that 12-weeks of CF  (250 mg of a 10% \nCF preparation taken two times per day) promoted \nfavorable changes in body composition in overweight \nmen.   In the present study, no significant changes  \n \nwere observed in body weight, fat content, or lean \nbody mass.  However, statistical trends were found in \ntotal scanned mass, which could suggest some \nalleviation in weight gain among overweight \nsubjects.  Overall, CF had no effect on the fat free or \nfat mass of the female subjects used in the study.  It is \npossible that more group differences could be seen if \ncontrols for exercise and/or diet were incorporated \nand/or the study was conducted in a larger \npopulation.  \n \nPsychological Analysis . A psychometric inventory \nwas used to analyze mood changes during each of the \nfour testing sessions of the study. This analysis \nmeasured potential changes in six different mood \nstates: tension-anxiety, depression-dejection, anger-\nhostility, vigor-activity, fatigue-inertia, and \nconfusion-bewilderment. The results of this \npsychological inventory revealed that regular \ningestion of the supplement produced no significant \nalteration in mood, except for the decrease in tension-\nanxiety over time. This decrease could be associated \nwith the possible effects of supplementation on body \nweight, which is an issue that often leads to tension-\nanxiety. Trends were observed in fatigue levels. \nSubjects taking the supplement appeared to \nexperience less fatigue over the course of the study. \nBecause there were no controls for physical activity \nin this study, only speculation can explain the \nchanges that occurred. It is possible that those in CF \nengaged in less activity with the idea that \nsupplementation would increase weight loss.  \n\n 62\nAppetite Analysis. An appetite invent ory was used to \nassess variables of appetite during each of the four \ntesting sessions of the study. This inventory \nmeasured changes in hunger, appetite, satisfaction \nfrom food, fullness, and overall quality of food. No \nsignificant differences were observed in appetite, \nhunger, energy, or overall quality of food. This shows \nthat the eating desires for both groups were \nmaintained. However, the significant time effect in \nsatisfaction from food found in CF and P suggests \nthat both groups received less enjoyment from the \nfood consumed. There was also a significant decrease \nnoted in feelings of fullness in CF from Week 0 to \nWeek 12. Even though appetite and hunger were not \nsignificantly affected by supplementation, it is \npossible that because CF re ceived less satisfaction \nfrom food that less food was eaten.  \n \nSummary. In conclusion, this study was performed in \nan attempt to further inves tigate the effectiveness of \nCF on body composition and general markers of \nhealth. The findings suggest that 12-weeks of CF \nsupplementation in free-living subjects have limited \neffects on body composition and no apparent \nclinically significant side effects.  However, CF has \nthe potential to positively influence the loss and \nmanagement of overall body weight possibly as a \nmeans of maintaining weight after weight loss.  Still, \nfuture research is needed to further explore its \ncapabilities.  \n \nACKNOWLEDGEMENTS \n \nThis study was conduced at University of Memphis \nwhen the primary researchers were affiliated with \nthat institution.  We would like to thank the subjects \nwho participated in this study and the laboratory \nassistants in Exercise & Sport Nutrition Laboratory at \nThe University of Memphis who assisted in data \nacquisition and researchers in the Exercise & Sport \nNutrition Laboratory at Baylor University who \nassisted with data analysis and manuscript \npreparation.   \n \nThis study was funded in part by a research grant \nfrom Sabinsa Corporation ( Piscataway, NJ ) in \ncollaboration with ImagiNutrition ( Laguna Niguel, \nCA).  Investigators independently collected, analyzed \nand interpreted data from this study and have no \nfinancial interest in the outcome of results reported.  \nPresentation of results in this study does not \nconstitute endorsement by researchers or their \ninstitutions of the supplement investigated. \n \nREFERENCES \n \n1. Agarwal, K.C., R.E. Parks. Forskolin: a potential antimetastic agent. Int J Cancer. 32:801-804, 1983. \n2. Caprioli, J., M. Sears. Forskolin lowers intraocular pressure in rabbits, monkeys, and man. Lancet. 958-960, April 30, 1983. \n3.     Burns, T.W., Langley, P.E., Terry, B.E., D.B. Bylund, L.R. Forte, Jr. Comparative effects of forskolin and isoproterenol on the  \n        cyclic AMP content of human adipocytes. Life Sci. 40: 145-54, 1987. \n4.     Litosch, I., Hudson, T.H., Mills, I., Li, S.Y., J.N. Fain. Forskolin as an activator of cyclic AMP accumulation and lipolysis in rat  \n        adipocytes. Mol Pharmacol. 22:109-15,    1982. \n5.     Diterpene forskolin (Coleus forskohlii, Benth.): A Possible New Compound for Reduction of Body Weight by Increasing Lean  \n        Body Mass Database [http://www.forlslean.com/clinical_studies.html] \n6. Godard, M.P., Johnson, B.A., S.R. Richmond. Body Composition and Hormonal Adaptations Associated with Forskolin \nConsumption in Overweight and Obese Men.  Obesity Research. 13:1335-1343, 2005.    \n7. Srivasta, S.K., Khatoon, CS, Mehrotra, S, R. Mehrotra. 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Pharmacodynamic effects of inhaled dry powder formulations of fenoterol and colforsin in asthma. Clin. Pharmacol.  \n      Ther. 53:76-83,","source_license":"CC0","license_restricted":false}