British Journal of Nutrition

Transcription

1 (2011), 105, q The Authors 2010 doi: /s The effect of fire supplement compred to helthy diet on ody composition, lipids, glucose, insulin nd other metolic syndrome risk fctors in overweight nd oese individuls Seely Pl, Alirez Khossousi, Colin Binns, Stvinder Dhliwl nd Vness Ellis School of Pulic Helth, Curtin Helth Innovtion Reserch Institute, ATN Centre for Metolic Fitness, Curtin University of Technology, GPO Box U1987, Perth, WA, Austrli 6485 (Received 3 Ferury 2010 Revised 20 My 2010 Accepted 5 July 2010 First pulished online 23 August 2010) Astrct Optimum levels nd types of dietry fire tht provide the gretest eneficil effects on metolic syndrome risk fctors in overweight nd oese individuls hve yet to e determined in clinicl trils. The present prllel design study compred the effects of fire intke from helthy diet v. fire supplement (psyllium) or helthy diet plus fire supplement on fsting lipids, glucose, insulin nd ody composition. Overweight/oese dults were rndomised to either control (with plceo), fire supplement (FIB), helthy eting plus plceo (HLT) or helthy eting plus fire supplement (HLT FIB). There ws significnt increse in fire intke in HLT FIB, HLT nd FIB groups up to 59, 31 nd 55 g, respectively, t 12 weeks when compred to control (20 g). Weight, BMI nd % totl ody ft were significntly reduced in FIB nd HLT FIB groups, with weight nd BMI significntly reduced in the HLT group compred with control t 12 weeks. HLT FIB nd HLT groups hd significnt reductions in TAG nd insulin compred with control t 6 nd 12 weeks, nd in insulin compred with the FIB group t 12 weeks. The HLT FIB, HLT nd FIB groups ll hd significnt reductions in totl cholesterol nd LDL-cholesterol compred with control fter 6 nd 12 weeks. The present study demonstrted tht simply dding psyllium fire supplementtion to norml diet ws sufficient to otin eneficil effects in risk fctors. However, high-fire diet consisting of psyllium supplement plus fire from helthy diet provided the gretest improvements in metolic syndrome risk fctors. Key words: Fire: Psyllium: Metolic syndrome: Oesity: Lipids: Insulin The growing prevlence of oesity crries with it the incresed risk of metolic syndrome risk fctors such s dominl oesity, therogenic dyslipidemi nd insulin resistnce, which increse the risk of CVD nd type 2 dietes (1). Studies hve shown tht overweight nd oese individuls consume fewer high-fire foods such s vegetles, fruit, wholegrins nd legumes nd more ftty nd high-energy-dense foods (2). Conversely, epidemiologicl nd cohort studies hve indicted tht high-fire diet is correlted with lower BMI nd lower incidence of hyperlipidemi, CVD nd dietes (2 6). Dietry fire is n edile component of ll plnts nd is defined s eing resistnt to digestion nd sorption in the humn gut, nd usully involves complete or prtil fermenttion in the lrge intestine (7,8). There re two min groups of fire: viscous (wter solule) including pectin, gum, mucilge nd psyllium, nd non-viscous (wter insolule) including cellulose, hemicellulose nd lignin (9). It is estimted tht Austrlin dults consume g of dietry fire/d (10) nd US dults consume on n verge 15 g fire/d (8). Present dietry fire recommendtions for dults in Austrli nd the USA re g/d to e consumed from fire-rich sources such s fruit, vegetles, legumes nd whole grins (11,12). Epidemiologicl nd cohort studies hve consistently reveled tht higher fire intkes re correlted with lower ody weight, BMI, wist circumference (13,14), (7,9,15 21) improved plsm lipid profiles nd improved glycemi nd insulinemi (5), indicting the enefits nd risk reduction for the metolic syndrome, CVD nd type 2 dietes. Liron et l. (17) found tht dietry fire intkes of $25 g/d ws correlted with reduced risk of high BMI, cholesterol nd hypertension nd tht g/d would hve even greter protective effects in middleged dults (17). However, clinicl trils hve proven to e less conclusive, prticulrly in reltion to weight loss. Arevitions: FIB, the supplement group who consumed fire supplement with their usul diet; HDL-C, HDL-cholesterol; HLT, helthy eting group who consumed the plceo with helthy eting regimen.; HLT FIB, helthy eting plus fire supplement group.; LDL-C, LDL-cholesterol; TC, totl cholesterol. Corresponding uthor: Associte Professor S. Pl, fx þ , emil s.pl@curtin.edu.u

2 Fire nd metolic syndrome risk fctors 91 Pittler & Ernst (22) found non-significnt difference in weight loss when reviewing twenty rndomised trils involving gur gum ( solule fire). Other intervention studies lso revel no chnge in ody weight (23). However, review y Howrth et l. (3) concluded tht in d liitum conditions, incresing fire intke y 14 g/d is ssocited with reduced energy intke nd ody weight loss. The diversity of the clinicl trils my prtly explin the inconclusive results s some trils involve incresing fire intke y consuming helthy diet of wholegrins, fruit nd vegetles (24 27), others involve intke of specific high-fire foods or enriched foods (28,29) nd certin others use fire supplementtion (23,30 32). There re lso few intervention studies ddressing the mount of dily fire intke required to improve metolic syndrome risk fctors in helthy overweight or oese individuls, popultion susceptile to the metolic syndrome. A direct comprison etween group tking fire supplementtion lone nd group tking incresed fire y dopting helthy eting pttern needs to e undertken to revel the effects from these different sources on chronic disese risk fctors in the overweight nd oese. Therefore, the im of the present study ws to investigte whether 12 weeks of dditionl dietry fire intke in the form of helthy diet or dietry fire supplement (psyllium) or comintion of oth would induce nd sustin improvements to metolic syndrome risk fctors, such s fsting lipids, glucose, insulin nd ody composition in overweight nd oese individuls. We lso compred the effects of different mounts of fire intke (low, moderte nd high) on metolic syndrome risk fctors to determine how much dietry fire intke ws most effective. Mterils nd methods Sujects Overweight nd oese individuls with BMI etween 25 nd 40 kg/m 2 nd ged etween 18 nd 65 yers were recruited from the community. Of ninety-four respondents, seventy-two were eligile to prticipte (thirty-seven men nd thirty-five women) nd commenced the study. Potentil prticipnts were screened y telephone nd they ttended t Curtin University to ssess their suitility for the study, t which time the detils of the study were explined. Exclusion criteri included smoking, lipid-lowering mediction, use of steroids nd other gents tht my influence lipid metolism, use of wrfrin, dietes mellitus, hypo- nd hyperthyroidism, crdiovsculr events within the lst 6 months, psychologicl unsuitility, mjor systemic diseses, gstrointestinl prolems, proteinuri, liver filure, renl filure, weight flututions over the pst 6 months nd vegetrinism. The present study ws conducted ccording to the guidelines lid down in the Declrtion of Helsinki nd ll procedures involving humn sujects were pproved y the Curtin University Humn Reserch Ethics Committee (Approvl Numer HREC 157/2004) with ll the prticipnts giving written informed consent. Methods This ws rndomised, single-lind, prllel-design study over 12-week period. The study prticipnts were rndomised into one of four groups: the control group (n 18), who consumed the plceo with their usul diet; the supplement group (FIB, n 18), who consumed fire supplement with their usul diet; helthy eting group (HLT, n 18), who consumed the plceo with helthy eting regime, nd helthy eting plus fire supplement group (HLT FIB, n 18), who consumed the fire supplement plus helthy eting regimen. The fire supplement consisted of 12 g of psyllium (Metmucil; P&G, Sydney, NSW, Austrli) nd the plceo consisted of 12 g redcrums with flvouring, which provided 1 5 g of solule fire. The redcrums provided n pproprite plceo due to its low energy nd fire content nd similrity in texture nd ppernce to the psyllium supplement. Depending on which group they were llocted to, prticipnts were instructed to tke either 12 g of the fire supplement or plceo, mixed with 250 ml wter, three times dily 5 10 min efore rekfst, lunch nd dinner. Psyllium is gel-forming mucilge from the Plntgo ovt plnt. The ioctive frction in psyllium is fire composed of highly rnched rinoxyln. Psyllium is solule fire tht is gel forming. Psyllium hs dvntges over other types of solule fire ecuse it is less redily fermented nd therefore cuses less fltulence nd dominl loting. It ws used in the present study s it would e esily tolerted nd is redily mrketed worldwide under the trde nme Metmucil. The sujects ttended riefing session on how to complete food records nd comply with the study protocol. The dietry intke over the course of the tril ws monitored through the completion of 3d weighed food diries t seline, 6 nd 12 weeks. Ad liitum helthy eting plns, s designed y registered dietitin, were prescried for the HLT nd HLT FIB groups for the 12 weeks, which included helthy mels nd sncks sed on the Dietry Guidelines for Austrlin Adults (11). These study prticipnts were sked to record their food nd drink intke for 3 d every 3 weeks to monitor the dherence to the guidelines (11) nd were given feedck nd strtegies if necessry. These prticipnts were tightly monitored to ensure their complince to the dietry guidelines. The prticipnts in the control nd FIB groups were sked to mintin their usul dietry intke for the durtion of the study. To monitor complince, ll the prticipnts were provided with mesuring cup to mesure either the fire supplement or plceo, they were required to complete diry to record their supplement consumption nd they were sked to return the empty nd non-empty continers of the supplements t their 6- nd 12-week visits.

3 92 S. Pl et l. Assessments The prticipnts ttended t Curtin University, fter h fst, for seline mesurements. Susequent to mndtory rest period of pproximtely 30 min, fsting lood smples (5 ml) were drwn y venepuncture. The collection of fsting lood smples ws repeted t 6 nd 12 weeks. Blood smples were centrifuged t 2500 rpm t 48C for 10 min using Hettich Rottin 48R centrifuge (Tuttlingen, Germny). Serum nd plsm were collected to mesure circulting levels of TAG, totl cholesterol (TC), HDL, LDL, insulin nd lood glucose. Serum nd plsm smples were stored t 2808C nd nlysed within 4 6 weeks of collection. Mesures of ody weight, height, wist nd hip circumference were lso undertken t seline, 6 nd 12 weeks. Body weight (UM-018 Digitl Scles, Tnit Corportion, Tokyo, Jpn) ws recorded in light clothing without shoes. Height ws mesured to the nerest 0 1 cm using stdiometer (26SM 200 cm; SECA, Hmurg, Germny) without shoes. Wist circumference ws mesured in the stnding position t the nrrowest re etween the lterl lower ri nd the ilic crest. Hip mesurement ws tken t the lrgest circumference of the lower domen. Totl ody ft nd len mss s well s percentge ft were ssessed y whole ody dul-energy X-ry sorptiometry (Lunr Prodigy; Lunr, Mdison, WI, USA) t seline nd t 12 weeks. The dul-energy X-ry sorptiometry mchine ws clirted nd phntom scn ws undertken dily. Week 0 control plceo with usul diet (n 18) Response to dvertisement (n 94) Week 0 FIB group fier suppl with usul diet (n 18) Eligile for prticiption (n 72) n 37 men n 35 women Rndomistion (n 72) Week 0 HLT group plceo with helthy diet (n 18) Week 0 HLT-FIB group fier suppl with helthy diet (n 18) Withdrwls fter commencement (n 3) Withdrwls fter commencement (n 2) Withdrwls fter commencement (n 6) Withdrwls fter commencement (n 4) Week 12 completed control (n 15) Week 12 completed FIB group (n 16) Week 12 completed HLT group (n 12) Week 12 completed HLT-FIB group (n 14) Completed study (n 57) Fig. 1. Detils of suject recruitment nd withdrwl. FIB, fire supplement group; HLT, helthy eting group with plceo; HLT-FIB, helthy eting with fire supplement.

4 Fire nd metolic syndrome risk fctors 93 Mesurements of lipids, glucose nd insulin Serum TAG nd TC were mesured y enzymtic colorimetric kits (TRACE Scientific Limited, Melourne, VIC, Austrli). Serum HDL-cholesterol (HDL-C) ws determined fter precipittion of po B-contining lipoproteins with phosphotungstic cid nd MgCl 2, the superntnt contining the HDL-C ws determined y enzymtic colorimetry (TRACE Scientific Limited). Serum LDL-cholesterol (LDL-C) ws determined y using the Friedewld eqution. Plsm glucose levels were mesured using the Rndox glucose GOD-PAP kit (Antrim, UK), ccording to the mnufcturer s instructions. Plsm insulin ws mesured y n ELISA kit (Dko Dignostic, Kkkyoym, Jpn). Sttisticl nlysis The smple size of the study is sed on the predicted 10 % reduction in TC, LDL-cholesterol, TAG, ody weight nd totl ody ft content fter intervention. A smple size of t lest sujects/group will provide sufficient power (. 90 %) to detect n estimted within nd etweengroup effect size of 0 56 t 5 % significnce level. Recruiting totl of seventy-two sujects (n 18) will ccommodte for 20 % dropouts. Sttisticl nlysis ws undertken using SPSS 11 for Windows (SPSS Inc., Chicgo, IL, USA). Dt were expressed s mens with their stndrd errors nd ssessed for normlity to ensure tht the ssumptions of the nlysis re met. The dt were nlysed using Generl Liner Models with seline vlue covrites. If significnt etween-groups effects were present, post hoc comprisons etween the tretment groups were mde using the Lest Significnt Difference method. Sttisticl significnce ws considered t P, The present clinicl tril ws registered with the Austrlin New Zelnd Clinicl Trils Registry. The registrtion numer is ACTRN nd tril we ddress is Results Sujects Seventy-two individuls were rndomly ssigned to one of the four test groups: control, FIB, HLT or HLT FIB for 12 weeks. Fifteen prticipnts withdrew from the study due to unrelted illness, work commitments, poor complince nd personl resons. Fifty-seven prticipnts (twenty-five mles nd thirty-two femles) completed the 12-week study (control: n 15; FIB: n 16; HLT: n 12; HLT FIB: n 14) s shown in Fig. 1. Suject chrcteristics in the four tretment rms t seline were not significntly different (Tle 1). Although there were some reports of minor loting initilly, ll sujects tolerted the supplements well with no dverse effects reported. Diet nlysis The self-reported food nd drink intke t seline, 6 nd 12 weeks re shown in Tle 2. There were no significnt differences in totl energy, crohydrte, protein, totl ft, sturted ft, monounsturted ft, polyunsturted ft nd fire etween the four groups t seline. The totl energy intke in the HLT FIB group ws lower (P¼0 031) y 13 % compred with the control group t 12 weeks. Fire intke ws higher (P,0 001) in the FIB group y 36 g, higher (P, 0 001) in the HLT group y 11 g nd higher (P,0 001) in the HLT FIB group y 39 g t week 12 compred with the control group. Fire intke in the FIB nd HLT FIB groups ws lso higher (P,0 001) thn the HLT group y 25 nd 28 g, respectively, t week 12. The HLT FIB group intke ws lso higher (P¼0 048) y 3 7 g thn the FIB group t week 12. Tle 1. Suject chrcteristics t seline (Men vlues with their stndrd errors) Control (n 15) FIB (n 16) HLT (n 12) HLT FIB (n 14) Chrcteristics Men SEM Men SEM Men SEM Men SEM Age (yers) Wt (kg) BMI (kg/m 2 ) Wist circumference (cm) Wist:hip rtio Fsting TAG (mmol/l) Fsting cholesterol (mmol/l) Fsting HDL-cholesterol (mmol/l) Fsting LDL-cholesterol (mmol/l) Fsting glucose (mmol/l) Fsting insulin (mui/ml) FIB, fire supplement group; HLT, helthy eting group with plceo; HLT FIB, helthy eting group with fire supplement. Men vlues were not significntly different etween suject chrcteristics t screening.

5 94 S. Pl et l. Tle 2. Reported dietry intke dt ssessed y weighed food records (Dily men vlues with their stndrd errors, n 57) Bseline Week 6 Week 12 Men SEM Men SEM Men SEM Totl EI Control FIB , HLT , HLT FIB Crohydrte (% of EI) Control FIB HLT HLT FIB Protein Intke (% of EI) Control FIB HLT HLT FIB Ft intke (% of EI) Control FIB HLT HLT FIB SFA intke (% of EI) Control FIB , 1 1 HLT HLT FIB MUFA intke (% of EI) Control FIB , 0 7 HLT HLT FIB , , 0 7 PUFA intke (% of EI) Control FIB , 0 5 HLT HLT FIB Fire intke (g) Control FIB c 1 9 HLT c HLT FIB d d 1 4 EI, energy intke; FIB, fire supplement group; HLT, helthy eting group with plceo; HLT FIB, helthy eting group with fire supplement.,,c,d Men vlues with unlike superscript letters were significntly different etween groups t 6 nd 12 weeks (P, 0 05). Men vlues were sttisticlly significnt from seline (P,0 05). The nutritionl dt recorded in 3-d food diries t seline, weeks 6 nd 12. Totl ft intke ws lower (P,0 001) in the HLT nd HLT FIB groups y 6 nd 15 %, respectively, t week 6 nd oth y 24 % t week 12 compred with the control group. When compred with the FIB group, totl ft intke ws lower (P, nd P¼0 020, respectively) in the HLT nd HLT FIB groups y 10 nd 8 %, respectively, t week 6 nd lower (P,0 001) in oth groups y 18 % t week 12. Sturted ft intke ws incresed (P, 0 05) in the control group t 12 weeks compred with seline. The HLT group lso registered n increse (P, 0 05) in sturted ft t 12 weeks compred with seline. Sturted ft intke ws reduced (P¼0 029) y 26 % in the HLT group nd reduced (P¼0 006) y 26 % in the HLT FIB group compred with the control group t week 12. Polyunsturted ft intke ws lso lower (P¼0 018) in the HLT group y 23 % nd reduced (P¼0 025) in the HLT FIB group y 27 % compred with the control group t week 12. Monounsturted ft intke in the HLT group ws lower (P¼0 008) y 24 % t week 6 nd lower (P¼0 047) y 20 % t week 12 compred with the control group. Body composition There were no significnt within-group chnges in ody weight, BMI nd % ody ft in the four groups s shown in Fig. 2. When mking etween-group comprisons, ody weight in the FIB, HLT nd HLT FIB groups ws lower (P¼0 007, P¼0 006 nd P, 0 001, respectively)

6 Fire nd metolic syndrome risk fctors 95 (A) (B) Weight (kg) Weeks 12 Weeks BMI (kg/m 2 ) Weeks 12 Weeks (C) Body ft (%) compred with the control group t week 12 (Fig. 2()). BMI in the FIB, HLT nd HLT FIB groups ws lso lower (P¼0 010, P¼0 011 nd P, 0 001, respectively) compred with the control group t week 12 (Fig. 2()). Dul-energy X-ry sorptiometry results reveled tht the percentge of totl ody ft in the FIB nd HLT FIB groups ws lower (P¼0 002 nd P, 0 001, respectively) compred with the control group t 12 weeks (Fig. 2(c)). There were no wist circumference differences within or etween groups (Fig. 2(d)). Fsting lood lipids Serum TAG levels decresed in the HLT nd HLT FIB groups t 6 nd 12 weeks compred with seline levels (Fig. 3). TAG levels reduced in the HLT FIB group y 27 % t 6 weeks (1 27 mmol/l, P¼0 044) nd y 33 % t 12 weeks (1 17 mmol/l, P¼0 016) compred with seline levels (1 75 mmol/l). Between-group comprisons reveled tht the TAG levels of the HLT nd HLT FIB groups were oth reduced (P¼0 008 nd 0 003, respectively) y 38 % (oth 1 27 mmol/l), t week 6 nd oth reduced (P¼0 001 nd P, 0 001, respectively) y 46 % (1 16 nd 1 17 mmol/l, respectively) t week 12 compred with the control group (2 05 mmol/l t week 6 nd 2 16 mmol/l t week 12). The TAG levels in oth the HLT nd HLT FIB groups t week 6 were lower (P¼0 009 nd 0 004, respectively) thn the FIB group nd lso lower (P¼0 005 nd 0 003, respectively) thn the FIB group t week 12. A comprison of the chnges in TAG levels in ll groups is shown in Fig. 3., (D) Wist circumference (cm) 6 Weeks 12 Weeks Fig. 2. Chnges in ody weight (A); BMI (B); % ody ft (C) nd wist circumference (D). The chnges in ody weight, BMI nd wist circumference from seline to 6 nd 12 weeks in control, fire supplement group (FIB), helthy eting group with plceo (HLT) or helthy eting group with fire supplement (HLT FIB) groups. The chnge in percentge ody ft from seline to 12 weeks in control, FIB, HLT or HLT FIB groups. Dt re mens with their stndrd errors. Men vlues were significntly different from seline (P, 0 05)., Men vlues with unlike letters were significntly different etween groups (P,0 05)., Control;, FIB; ;, HLT;, HLT FIB. There were etween- nd within-group differences in fsting TC levels in the prticipnts over the 12-week intervention period (Fig. 4()). The TC levels decresed from seline in the HLT (6 28 mmol/l, P¼0 002) nd HLT FIB (6 34 mmol/l, P¼0 014) groups oth y 17 % (5 22 nd 5 29 mmol/l, respectively) t week 6. TC serum levels lso significntly reduced t week 12 in the FIB (5 01 mmol/l, P¼0 001), HLT (5 15 mmol/l, P¼0 001) nd HLT FIB (5 07 mmol/l, P¼0 003) groups y 15, 18 nd 20 %, respectively, from seline. Comprison of differences etween groups reveled tht TC levels in the FIB, HLT nd HLT FIB groups were lower y 15 % (P¼0 003), 16 % (P¼0 001) nd 15 % (P¼0 02) t week 6, respectively, nd lower y 21 % (P, 0 001), 19 % (P,0 001) nd 20 % (P,0 000), respectively, t week 12 compred with the control group. There were no significnt differences in TC levels etween the FIB, HLT nd HLT FIB groups t weeks 6 nd week 12. A comprison of the chnges in TC levels in ll groups is shown in Fig. 4(). Fsting LDL-C levels decresed in the FIB, HLT nd HLT FIB groups from seline (3 97, 4 16 nd 4 19 mmol/l, respectively) t week 6 y 22 % (3 10 mmol/ l, P¼0 013), 22 % (3 24 mmol/l, P¼0 006) nd 22 % (3 26 mmol/l; P¼0 029), respectively (Fig. 4()). Fsting LDL ws significntly reduced in the FIB, HLT nd HLT FIB groups from seline t week 12 y 27 % (2 88 mmol/l, P¼0 002), 26 % (3 07 mmol/l, P¼0 002) nd 30 % (2 93 mmol/l, P¼0 004), respectively. Betweengroup comprisons of LDL levels reveled tht the FIB,

7 96 S. Pl et l. TAG (mmol/l) Weeks 12 Weeks Fig. 3. Chnges in fsting serum TAG. The chnge in TAG from seline to 6 weeks nd 12 weeks in control, fire supplement group (FIB), helthy eting group with plceo (HLT) or helthy eting group with fire supplement (HLT FIB) groups. Dt re mens with their stndrd errors. Men vlues were significntly different from seline (P,0 05)., Men vlues with unlike letters were significntly different etween groups (P,0 05)., Control;, FIB;, HLT;, HLT FIB. HLT nd HLT FIB groups hd lower LDL levels y 23 % (P,0 001), 18 % (P¼0 005) nd 17 % (P,0 001), respectively, compred with the control group t week 6. The LDL level ws lower (P,0 001) fter 12 weeks of intervention in the FIB, HLT nd HLT FIB groups y 29, 24 nd 28 %, respectively, compred with the control group (4 05 mmol/l). A comprison of serum LDL-C chnges in ll groups is shown in Fig. 4(). The HDL-C levels incresed significntly (P¼0 02) y 21 % in the HLT FIB group t week 12 (1 60 mmol/l) compred with seline (1 27 mmol/l). Between-group comprisons reveled no significnt differences in HDL levels s shown in Fig. 4(c). (A) TC (mmol/l) Weeks 12 Weeks Fsting glucose nd insulin Within-group comprisons reveled tht fsting lood glucose levels were not significntly chnged in ny tretment group compred with seline or week 6 s shown in Fig. 5(). However, when compring etween-group effects, glucose levels were 14 % (5 16 mmol/l, P¼0 03) lower in the HLT group compred with the control (6 00 mmol/l) group t week 6. There were no significnt etween-group differences t week 12. Fsting insulin levels decresed t week 12 in the HLT group y 24 % (15 62 mui/ml, P¼0 03) nd in the HLT FIB group y 33 % (13 71 mui/ml, P¼0 01) compred with seline (20 44 nd mui/ml, respectively) (Fig. 5()). When mking etween-group comprisons t week 6, fsting insulin levels were lower in the HLT group y 5 % (17 33 mui/ml, P¼0 05) nd lower in the HLT FIB group y 8 % (16 94 mui/ml, P¼0 02) compred with the control group (18 27 mui/ml). When compred with the control group t week 12 (19 89 mui/ml), insulin levels decresed in the HLT nd HLT FIB groups y 21 % (P,0 001) nd 31 % (P,0 001), respectively. When compred with the FIB groups t week 6 (19 53 mui/ml), insulin levels were significntly lower in the HLT group y 11 % (P¼0 02) nd in the HLT FIB group y 13 % (P¼0 01). At week 12, insulin levels were lower in the HLT group y 19 % (P¼0 01) nd in the HLT FIB group y 28 % (P, 0 000) compred with the FIB group (19 19 mui/ml). A comprison of insulin chnges in ll groups is shown in Fig. 5(). (B) LDL (mmol/l) Weeks 12 Weeks (C) 0 50 HDL (mmol/l) Weeks 12 Weeks 0 25 Fig. 4. Chnges in totl cholesterol (TC) (A); LDL cholesterol (B) nd HDL cholesterol (C). The chnge in TC, LDL nd HDL cholesterol from seline to 6 weeks nd 12 weeks in control, fire supplement group (FIB), helthy eting group with plceo (HLT) or helthy eting group with fire supplement (HLT FIB) groups. Dt re mens with their stndrd errors. Men vlues were significntly different from seline (P,0 05)., Men vlues with unlike letters were significntly different etween groups (P,0 05)., Control;, FIB;, HLT;, HLT FIB.

8 Fire nd metolic syndrome risk fctors 97 (A) (B) ,, Weeks 12 Weeks Glucose (mmol/l) Insulin (mmol/l),,c 6 Weeks c 12 Weeks Fig. 5. Chnges in fsting serum glucose (A) nd insulin (B). The chnge in glucose nd insulin from seline to 6 weeks nd 12 weeks in control, fire supplement group (FIB), helthy eting group with plceo (HLT) or helthy eting group with fire supplement (HLT FIB) groups. Dt re mens with their stndrd errors. Men vlues were significntly different from seline (P,0 05).,,c Men vlues with unlike letters were significntly different etween groups (P,0 05)., Control;, FIB;, HLT;, HLT FIB. Discussion The present study demonstrted tht simply dding psyllium fire supplementtion to norml diet (FIB group, 55 g/d) ws sufficient to see improvements in TC nd LDL-C s well s ody weight, BMI nd % ody ft compred with control. Consuming helthy diet with moderte fire intke (HLT group, 30 g) showed improvements in TC, LDL-C, TAG, insulin, ody weight nd BMI compred with the control. Consuming oth the fire supplement nd the helthy diet (HLT FIB, 59 g) showed enefits in ll of these prmeters compred with control with non-significnt trend towrds greter effect on TC, LDL-C, TAG, insulin, ody weight, BMI nd % ody ft compred with the other intervention groups. Therefore, recommendtions for. 30 g/d of fire for overweight or oese individuls, derived from dietry sources in conjunction with psyllium fire supplementtion, my e pproprite to improve metolic syndrome risk fctors in this group. Mny studies hve found tht incresing fire intke hs resulted in incresed stiety, reduced hunger, decresed energy intke nd weight loss (3,33). In the present study, we found tht ody weight nd BMI were significntly lower in the FIB, HLT nd HLT FIB groups compred with the control t 12 weeks lthough the FIB nd HLT FIB groups lso showed significnt reduction in % ody ft. The reduction in % ody ft in these two groups my indicte tht high fire intke of over 55 g from psyllium supplement, with or without helthy diet, my influence ody composition s well s ody weight. The gretest nthropometric chnges were found in the HLT FIB group, which my e prtly explined y significnt reduction in reported totl energy intke. Epidemiologicl nd cohort evidence indicte tht diets rich in fire re ssocited with lower ody weight (2,6,17). A recent study y Du et l. (13) found n inverse ssocition of totl dietry fire nd cerel fire with weight nd wist circumference chnge in cohort of Europen dults who were studied over n verge period of 6 5 yers. Interestingly, the present study reveled no differences in wist circumference in ny intervention group, which my suggest tht longer time is required to see such oservle effects. Howrth et l. (3) reviewed twelve intervention studies nd found tht when energy intke is d liitum, n increse of 14 g/d of fire over stndrd diet resulted in 10 % decrese in energy intke nd 1 9 kg decrese in ody weight over 3 8 months. However, in two reviews undertken y Pittler & Ernst (22,34), they found unconvincing evidence tht fire supplements cn reduce ody weight. Other intervention studies lso revel no chnge in ody weight (23,35). Fire s effect on stiety nd reduced energy intke my e due to its reduced energy density nd incresed chewing time (33). Fire my ffect stiety y slowing gstric emptying time, incresing viscosity in the gstrointestinl trct nd therefore reducing postprndil glycemi nd insulin secretion (4). Fire my lso influence stiety hormone levels such s ghrelin (36). A review y Pereir & Ludwig (33) reveled tht dietry fire hd eneficil influences on stiety nd energy intke in seventeen studies, wheres seven studies reported mixed results nd three studies reported no effects. In our previous cute study, 15 g of dietry fire did not ffect the hunger nd stiety in the postprndil period (37). Evidence is inconclusive in reltion to the effects of fire on weight loss, ut the present study suggests tht lrger mounts of fire (.30 g) my e required to lter energy lnce sufficiently for weight loss nd to ring out chnges in ody composition. The HLT nd the HLT FIB groups hd the gretest impct on lowering serum TAG levels t 6 nd 12 weeks compred with the control. Previous studies hve shown inconsistent results regrding the effect of dietry fire on TAG metolism (9) with most of them indicting no effect (21,27,28). However, in 6-week rndomised study y Chndli et l. (24) in sujects with type 2 dietes, intke of high-fire diet with high-solule fire content (totl fire intke 50 g/d, including 25 g/d solule fire) lowered TAG concentrtions y 10 2 % (24). Although mechnisms re not fully understood, the pprent

9 98 S. Pl et l. hypotricylglycerolemic effects of psyllium nd other solule fires my e relted to dely in the sorption of TAG nd crohydrtes from the smll intestine (38).In the present study, there ws no oserved reduction in serum TAG levels in the FIB group despite fire intke similr to the HLT FIB group of over 55 g nd greter thn the HLT group fire intke of 31 g. Wu et l. (9) found tht the highest quintile of fire consumption (totl, non-viscous nd pectin) ws ssocited with the lowest TAG levels. The psyllium supplement consumed in the present study my not e s effective s the multiple sources of fire from consuming non-viscous fires nd pectin from wholegrins, fruit nd vegetles. Consuming fire supplement (FIB) or consuming helthy diet (HLT) oth reduced serum TC nd LDL levels, ut the comintion of oth, in the HLT FIB group, produced the gretest reduction, lthough there ws no significnt difference etween the FIB, HLT nd HLT FIB groups. This indictes tht fire intke t 30 g or over ws sufficient to reduce serum TC nd LDL-C whether from consuming helthy diet, fire supplement lone or oth comined. Mny clinicl nd niml trils hve demonstrted the hypocholesterolemic effects of solule fires (17,20,21,27,39,40). A met-nlysis y Brown et l. (21) found tht solule fire from ots, psyllium, pectin nd gur gum ech reduced TC significntly. Psyllium s hypocholesterolemic properties hve een well reserched, with studies indicting tht the effects do not depend on the mount of ft or cholesterol in the diet (21,29,30,41,42). Brown et l. (21) concluded tht ech grm of fire from psyllium reduced TC nd LDL-C concentrtions y nd mmol/l, respectively. Solule fire is thought to entrp ile cids, resulting in greter fecl loss (30), nd is thought to reduce cholesterol sorption nd ile cid resorption y disrupting the intrluminl formtion of micelles (43,44). There ws no difference in HDL-C etween groups during the study. However, HDL-C incresed in the HLT FIB group from seline during the study nd it ws 19 % higher t the end of the study. Studies hve shown tht dietry fire does not ffect HDL-C (45). Therefore, the HDL-C increse in the HLT FIB group my hve een due to chnges in other dietry components during the study or relted weight loss in these sujects. Weight loss hs een ssocited with incresed HDL- C (46). Interestingly, Jenkins et l. (47) reported tht HDL-C ws significntly decresed fter 4 weeks of psyllium supplementtion in weight-stle helthy sujects. Therefore, the present study emphsises the importnce of ccompnying weight loss with incresed dietry fire to prevent the reduction in HDL-C. Previous studies hve reported n ssocition etween high fire consumption nd reduced fsting insulin (20). Ludwig (5) found tht, when djusted for BMI, higher levels of insulin were found in individuls who consumed the lest fire, indicting tht low-fire diet stimultes higher insulin response compred with high-fire diet. Solule fire, such s psyllium, my improve insulin sensitivity y incresing the viscosity of the stomch contents, which slows the digestion nd sorption of crohydrte nd other nutrients (31,48). In the present study, insulin levels decresed significntly in the HLT nd HLT FIB groups compred with the control nd FIB groups t 12 weeks. Simply consuming dditionl fire s psyllium supplement ws not sufficient to influence insulin levels, even t 55 g fire/d. The consumption of helthy diet ppered to hve more of n influence on insulin levels which could e relted to other fctors in tht diet. In the present study, the reduction in ody weight in the FIB, HLT nd HLT FIB groups nd the lowered TAG nd insulin in the HLT FIB nd HLT groups my lso hve een influenced y dietry fctors such s reduced ft intke (49,50). The two groups tht hd the reduction in serum TAG levels (HLT FIB nd HLT) lso recorded reduction in reported % energy intke from totl dietry ft nd sturted ft nd n increse in PUFA compred with the control group (Tle 2). However, the control group showed significnt increse in % energy from sturted ft compred with seline, which my prtly ccount for the decrese in TC nd LDL in the FIB, HLT nd HLT FIB groups. The mount nd type of ft consumed in the diet cn influence serum TAG levels (15) nd serum cholesterol levels (29), which my hve hd some influence in the present study. The eneficil chnges in TC, LDL-C, TAG nd insulin levels in the intervention groups my lso e relted to reduced ody weight nd reduced diposity (Fig. 2) s result of energy restriction. Non-significnt energy restriction occurred in the FIB nd HLT groups nd significntly in the HLT FIB group reltive to control. Numerous studies hve reported the improvements in iomrkers with energy restriction nd weight loss (51 55). Most of the sujects in the present study hd wist circumference greter thn tht specified y the ATP III Clinicl Identifiction of Metolic Syndrome (1) nd they hd t lest one or two other metolic syndrome risk fctors or were orderline cndidtes. Mny in this group will eventully progress to estlish the metolic syndrome if their oesity continues nd lifestyle fctors remin unchnged. In the present study, if consumption of high-fire diet (. 50 g/d) over 12 weeks resulted in grdul improvements leding to significnt reductions in weight, % ody ft, lipids nd insulin when compred to control, then intke over longer period my provide greter results nd improved outcomes for overweight nd oese individuls. Given tht the psyllium supplement tken in conjunction with helthy diet ws well tolerted, investigtions into the long-term intke of.50 g fire/d in this group should e pursued further. In the present study, the comprison etween norml diet (control), norml diet with psyllium fire supplement (FIB), helthy diet (HLT) nd helthy diet

10 Fire nd metolic syndrome risk fctors 99 with psyllium fire supplement (HLT FIB) helped to demonstrte the mount of fire tht is sufficient to improve some of the metolic syndrome risk fctors in overweight nd oese individuls s well s the effectiveness of psyllium supplementtion nd helthy dietry prctices. Since the helthy diet nd psyllium fire supplement (HLT FIB) produced the est results in reltion to improving metolic syndrome risk fctors compred with the other groups, similr dietry regimen could e prescried to overweight nd oese individuls, popultion susceptile to the metolic syndrome, CVD nd type 2 dietes. Therefore, further investigtions into incresing dietry recommendtions for dietry fire intke. 30 g/d for overweight or oese individuls from dietry sources in conjunction with fire supplementtion should e undertken. Acknowledgements This tril ws prtilly funded y the ATN Centre for Metolic Fitness. A. K. coordinted the tril, conducted dt collection, sttisticl nlysis nd hd input into the mnuscript. The uthors declre tht they hve no conflicts of interest. S. P. conceived of nd designed the study, wrote the mnuscript, nd supervised the study nd the sttisticl nlysis. S. D. hd input into the sttisticl nlysis. C. B. nd V. E. hd input into the writing of the mnuscript. References 1. Grundy S, Brewer H, Cleemn J, et l. (2004) Definition of metolic syndrome: report of the Ntionl Hert, Lung nd Blood Institute/Americn Hert Assocition Conference on scientific issues relted to definition. Circultion 109, Slvin JL (2005) Dietry fier nd ody weight. Nutrition 21, Howrth NC, Sltzmn E & Roerts SB (2001) Dietry fier nd weight regultion. Nutr Rev 59, Liron D (2007) Dietry fier nd control of ody weight. Nutr Met Crdiovsc Dis 17, Ludwig DS (1999) Dietry fier, weight gin, nd crdiovsculr disese risk fctors in young dults. JAMA 282, Kromhout D, Bloemerg B, Seidell JC, et l. 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