European Joural of Clinical Nuition (2015) 69, 592-597 © 2015 Macrien Publishes Uiited Alright eserved 08583007715 wonw.nature.comiejen ORIGINAL ARTICLE Substitution of red meat with legumes in the therapeutic lifestyle change diet based on dietary advice improves cardiometabolic risk factors in overweight type 2 diabetes patients: a cross-over randomized clinical trial 5 Hosseinpour-Niazi'?, P Mirmiran’, M Hedayati* and F Azizi> BACKGROUND/OBJECTIVE: The objective ofthis study was to determine the effects of substitution of red meat with legumes in the Therapeutic Lifestyle Change (TLO) diet on cardiometabolic isk factors in type 2 diabetes patients based on dietary education SUBJECTS/METHODS: This study was a randomized, controlled, cross-over tial. Thirty-one participants (24 women and 7 men; age: 58.1 4600 years) with type 2 diabetes were randomly assigned to consume a control det (legume-fee TLC diet) and lequme-based, TLC diet for & weeks. Lequme-based TLC diet was the same as the control dit, but the legume-based TLC group was advised to replace two servings of red meat with legumes, 3 days per week. After the interventional period, a washout period was conducted for 4 weeks. The groups were then advised to follow the alternate treatment for 8 weeks. Cardiometabolic rsk factors were measured. RESULTS: Compared with the legume-ftee TLC diet, the legume-based TLC diet significantly decreased fasting blood glucose (P=0.04) fasting insulin (P= 004), triglyceride concentrations (P=0.04) and low-density lipoprotein cholesterol (P= 0.02). Total cholesterol concentrations decreased after consumption of both TLC diet and legume TLC diet however, the data did not differ significantly between the two diets. body mass index (BMI, waist citcumference, systolic and diastolic blood pressures did not change significantly after consumption of either the legume-ftee TLC diet or the legume-based TLC diet. CONCLUSIONS: Dietary advice given for substitution of red meat with legume intakes within 3 TLC det-improved lipid profiles and ‘lycemic control among diabetes patients, which were independent from BM change. This trial was registered in the iranian Registry of Clinical Trials (http/Awwirctir) as IRCT201202251640N7, European Journal of Clinical Nutrition (2015) 69, $92-587; doi:10.1038/ejcn.2014.228; published online 29 October 2014 INTRODUCTION Cardiometabolic risk factors are the most frequent problems ‘among type 2 diabetes patients; consequently, interventions that decrease these catdiometabolic isk factors are considered beneficial to health. In previous investigations, intakes of meat? fruit and vegetable,’ dary products’ and whole grains” appeared 10 influence the risk of catdiometabolic factors among diabetes Patients, either positively or negatively, but legume intakes have hot been emphasized enough.” Legumes, including beans, lentils, peanuts, peas and soybeans, could reduce the risk of the ‘cardiometabolc risk factors through their beneficial components, that is, complex carbohydrate, vegetable protein, soluble fiber, low-glycemicindex and high content of isoflavones.” Current dietary guidelines for Americans recommend consumption of at least three cups of legumes per week for health promotion and disease prevention? ‘A therapeutic approach that can control cardiometabotic risks might have beneficial effects for diabetes patients. The ‘Therapeutic Lifestyle Change (TLC) diet is currently recommended by the Adult Treatment Panel of the National Cholesterol Education Program to lower the risk of cardiometabolic rsk {factors In previous studies, inclusion of soy in the TLC diet or Dietary Approach to Stop Hypertension had beneficial effets on ‘cardiometabolic risk factors;"""? however, soybean intake is not usually part of a traditional dietary pattem, whereas the intakes of ‘other legumes is traditional. The current study examined the effects of substitution of red meat with non-soy legumes in the TLC diet on cardiometabolic risk factors among averweight type 2 diabetes patients, based on dietary education, MATERIALS AND METHODS Participants ‘Type 2 dabetes patients who had serum glucose levels and medication doses that had been stale fot 3 months were recruited from the clinic of Taleghani hospital Tehran an. during 2012. Partkipants were considered having diabetes If fasting blood glucose (FBG) was > 126 ma/dl or they ‘Were using ora lucose-lowering agents. Egle participants Nad 2 clinical ‘Turton and Endocrine Reseach ent, Reseach stat or Endorne Sciences, Shall Behes Unverty of Medel Seences,Tehan, Fn “Obey Reach Cente Aeeach state for Endocine Sconces Shahid Sees Unierty of Neil Sciences, Tetra, ko "Orparment of Cina! Naion and Dietetic, Fecal of Nation Sciences and Food Technolgy Nona ution and Food Technology Research tae Shai hes Univeray of Medal Scence Teron, kan “Cer and Maaclr esearch Center, Reseach insu fr Erdouine Sciences, Satis Bees Unversity of Mea Scenes, Tran, Kan and “Endoune Reseach Cents, Reseach institute fx Endocine ences Shahid Behe Univeraty of Media! Scenes Tehran an. Corespondence Or P Mimian, Department of Cia ation and Det, Fc of ution sere re ond eek eer! Manon an Fond Yeoelogy Rese Mae, eRe Ue Medel Sees Tera an Racied 17 May 2014 revised 30 August 201; accepted 12 September 2014; published online 29 Cctber 2014diagnosis of ype 2 diabetes, body mass index (BN) 25-30 kg/m’, were ‘age! 20-75 yaar, were nan-imoler, were nat curently receiving insulin ‘therapy and didnot have any cardiac, hepatic oF renal function eisorers ‘total of 40 type 2 diabetes patients were screned for incision in the study. All paricipants provide informe written consent. This study Was approved by the research council and ethics committee ofthe Research for Endocrine. Sciences, shania eheehti Uniersty of Medica! Sciences (registered in htp/inwierci ID umber IRCT20120225 6407), Study design This was 2 randomized crossover study. During the run‘in period (2 weeks) the participants consumed thei avn usval cit (50% of energy ‘om carbohydrate, 15% of energy from protein and 35% of energy from fat) with restrictions tat inckided no typeof legume. After 2 weeks ofthe rurvin period, patients were randomly asigned to one of the two diet intervention groups: legumefree TLC diet or legumebased TLC diet Random allocation of patients to intervention groups wos peforned using fandom sequencing generated inthe Statistical Package for Socal Sciance {SP55 Inc, Chicago, Il, USA} at the end of the turin period, and randomization was periormed by an assistant. After the interventional Petlod, 2 washout period was conducted for 4 weeks: then, the Groups followed the alternate treatment for 8 weeks. Because ths was 9 Satay Intervention, patients and investigators were not blinded. For asezting the Git complance, the participants were visited every week for 30-15 min per patient at the baseline and during intervention Compliance was assessed by duting each weeky vist when the 3-day diet, records were collected: the pancipans were educated by dietkians on Substitution of red meat by legumes, ancl advised to reduce saturated fatty {acid and cholesterol intakes and incase fiber intakes. Parbcipants also feceived education on using an exchange st of foods and preparation of the diet record, Every parcpant had to bring her 3day diet recor, Including 2 weekdays and 7 weekend day, at each Ws, Each food and beverage was then coded according to the prescrbed protocel and analyzed for content of energy and the other nutients by using NUTRITIONIST Il software (version 7.0; N-Squared computing Salem, OR, USA, which design for tranan foods. Estimated nurvent intakes fom al fecords collected. during. the intervention were averaged. for the determination of dletary complance. Inthe legume-ree TLC det, mean intake of energy, protein at, saturate fatty acid, monounsaturated fatty ‘acid and carbohydrate was determined by the dct record divided by the fecommended amounts of these nutints according to calorie requie ments ofeach patent. based on equations suggested by the Institute of Medicine, and Food and Nutrition Board"*™* Compliance was defined 90% In addition, intakes of cholesterl ad fer were according to the TLC diet {= 200mg cholesterol and 25-304 fiber intake) Inthe legume based TLC diet in adation tothe above, intakes of legume >90% of those Prescribed were considered as good compliance. Patcipants were asked otto change thir habitual physical acy levels forthe duration ofthe study. Inthe curent study, patents were not on @ weight-reducing dle, because weightloss was not a goal ofthe curent stu. Legumes intake and carlometabolc rik factors 5 MosseinpourNiazi et af Diets Two diet interventions were used in the curent study: (1) control diet wich was a legume free TLC det that consisted of SO-6O"% carbohydrate, 158 protein and 25-35% of encrgy from fat (-< 7% saturate fat, Up © 20% ‘monounsaturated fat and up 10 105 polyunsaturated fat) and “= 200 mg cholesterol and 25-304 fiber Intake; and (2) legume-ased TLC det, hich was the same 98 the contol cet, but the partpants were Bevised to replace to servings of red meat witn diferent types of cooked legumes suc as lens, chickpeas, peas and beans 3 days per week Half 2 ‘up of cooked legumes was considered a5 one serving of fed mest hutientcompestons ofthe lagumefree TLC diet and legume-based TLC diet consumed by the study participants are shown in Table 1. Measurement Cardiometabolic foctors inchided FBG, blood pressure, BML waist Circumference and pid profiles. Weight was measured using dig sales {Seca, Hamu, Germany), whe the participants were minimally clothed and not wearing shoes, and it was recorded to the neoest 1009, Height was messured while participants were standing without shoes, with thei shoulder in a normal positon, using a tape fixed to the wall. and it as recorded tothe nearest 0.5 cm BMI 35 calculated as weight (hg) divided by the square of height (m’). Waist circumference was measured at the level of the umbileus ste, using an outstretched tape meter, thou pressure to body surfaces, and it was recorded to the nearest 05cm, Systolic and diastolic blood pressures were measured sing a standard mercury sphygmomanometer, on the ight arm after a 15min rest 8 Siting postion. Twa measurements were taken at Imi intervals, andthe average of the measurement was recorded 35 the participants blood pressure. Adetional information about age, medial history, current use of medications. and cigarette smoking were obtained using. a9. oFal questionaire. Physial activity was assessed using an oral questionnaire, Iheludng 2 let of eommon setvies of daly if. the fequency and the mount of time spent on activities per week over the past 12 months were dacumented” Leva of physical acthity were expressed ae metabolic ‘equivalent hours per sock, Biochemical assessment AMter 12-I4h of overnight fasting, blood semples were diavm into vacutaner tubes in siting poston, from all study participants. Serum was separated and frozen at ~70°C. on the day of blood collection for biochemical analyss. All Blood analyses were performed at the TLGS research laboratory, using a Selectra 2 autoznalyeer (Vita Scintife, Spanketen, The Netherlands). The laboratory staf was blinded to the treatment status. Serum tighjceride concentrations were measured sing Uighyeere kits (Pars Azmoon Inc, Tehvan, Iran) by the enzymatic Calorimetic test with glhcerol phosphate ‘oxidase, “HOL_ cholesterol ‘was measured. afer precptation of the apolipapreteinB-containing lipoproteins with phosphotungistic acd, Serum fsting glucose concentra tion was assayed using an enzymatic colorimetic method with the Table 1. Dietary intakes ofthe participants by intervention period Daily dietary intake Legume fee TC dee Legume bosed TU det* P washout vents Energy (kcal) 2030225 075 2078220 Carbohydrate (% energy) 536213 39 ‘sa5215 Teta fat (4 eneray) 325206 032 323209 Protein (5 eneray) 139205 oat 133207 Saturated fatty acid (6 energy) 71205 025 123206 Monounsaturated faty acd (energy) 175409 oa 1ab204 Polyunsaturated ftty acid (% energy) 79208 oat 51202 Cholesterol (g) 1929 004 pse3 Total ber (9) 31azis 0.03 242209 Magnesium (mg) 450254 003 30z34 Meat (serving per day) 3802 Oo 35202 Legume (serving per week) 61201 =0001 a7201 {Abbreviation TL therapeutic este change. "This det was the same as lagume ee TLC cet two servings of red meat were replaced with ronsay legume suchas lentils, chickpeas peas an beans, 3 days per weck Hal 3 cup of cocked legume Was considered 35 one serving of el meat or Poul "Mean and $m, [al uch vals {© 2015 Mocmilan Publishers Limited Fropeon Journal of Clinical Nutriion (2015) 592-597 593Legumes intake and cardiometabolc rk factors 5 MosseinpourNazi et a! 504 ‘glucose oxdase technique. Total cholesterol was assessed with cholestero ‘esterase and cholestrol oxidase using the enzymatic colorimetic method, Lowdensity lipeproten (LDL) choesterl was measured enzymatically using commercially avalable kts (Pars Azmun). Inter and inaassay «coefficients of valtlons were both 2.2% for serum glucose, 2 and 0.5% for high-density Fpoprotein (HDL-C) end total cholesterol and 1.6 and 0.6% for teighcerides, expectively Statistical analysis ‘Tre Statistical Package for Social Science (version 15.0 SSS Ine was used {or statistical analyses, Batline and end-obintevention values were used 1 calulate the changes in each of the cardiometabolic factors, Paired est was used to compare baseline and end:ofintewention values in ‘each group. Repeated-measures analysis of variance was used to compare means ofcardiometabolic factors atthe ed ofthe intervention det, with baseline values, age and. physical aciviy as covarates. Results are ‘expressed a5 mean 25. A Pvalue < 005 was considered significant Baseline and end-ofntervention values ony for compliant partcipants| (n=31) were used in the analysis (patients completing two intervention ets during & weeks of treatment with compliance). Subsequently according (0 the intento-teat approach, all analyses were dane using dta for participants with compliance and noncompliance of let intervention (n= 38). Finally, analyses using imputation of mising datz was dene (n= 40) the amount of missing data was small andthe resus ‘Were consistent across the various approaches Inthe curtent stud, LDL cholesterol was the primary outcome and ota ‘cnoestaol and FBG were other prespecified putcomes, flood presure, ‘wglycerdes and HDL cholesterol and insulin were secondary outcomes. RESULTS ‘Thirty-one of the 40 participants who began the diet intervention ‘completed the entire cross-over study. Nine participants dropped ‘out because of changes in medications or because they had a poor compliance with the intervention protocol (Figure 1). The ‘mean age of participants who completed the study was 58.160 years; 774% were women. Activity levels of participants remained {the same across all study periods (in legume-free TLC diet group: 2:56:02; in legume-based TLC group: 249:+0.2). Analysis of the ‘diet records Is shown in Table 1. The lequme-based TLC diet that ‘emphasized substitution of red meat with legume intake had higher amounts of legume intake (6.1 vs 1-1 serving per week: P-<0001) and lower amounts of meat intake (38 vs 49 serving per day; P= 0.04), compared with the legume-ree TLC diet; there ‘was no significant difference in energy intake between the two ‘groups (P=0.78). The results were the same with regard to the intake of percentage of the protein (P=0.4), total fat (P= 032), ‘carbohydrate (P= 0.89), saturated fatty acid (P= 0.25), monounsa- turated fatty acid (P=087) and polyunsaturated fatty acids (P=01). The legume-based TLC diet had a higher amount of {aking inn i ot ropa att vl romaing od stp 022) smi ero [Beans bs Traps oie ng e=] [contend it ernie 19] Tan Tp ee ange) Preto wm L Figue 1. Flowchart for the participants. European Journal of Clinical Notetion (2015) 592-597 {© 2015 Macmilan Publishers Limitedtotal fiber (31.4 vs 269 per day; P=0.03) and magnesium (450 vs 408mg per day; P=0.03) and lower cholesterol {129 vs 169.9 per day; P=0.04) compared with the legume-ree TLC diet Cardiometabolic factors No significant diferences in the baseline characteristics of patients ‘were observed across the diet periods. Effects of the two diets on ‘ardiometabolic factors are shown in Table 2. After consumption ‘of both the legume-ree TLC and legume:based TLC diets, FG, fasting Insulin, triglyceride concentrations, LDL cholesterol and serum total cholesterol showed significant decreases from base- line values. Compared with the legume-ftee TLC diet, the legume based TLC diet significantly decreased FOG (-195 455 vs 287467, P-<0.001), fasting insulin (-1505 vs ~25=04, P=0.006), triglyceride concentrations (-195+64 vs ~ 385266, P=0.02) and LDL cholesterol (-8.7+27 vs ~15.6+5.1, P=0.02) Total cholesterol concentrations decreased after consumption of both TLC and legume TLC diets; however, the difference was not significant. BMI, waist circumference and systolic and diastolic blood pressures did not change significantly ater consumption of either of the two diets (Table 2) DISCUSSION In the current study, we observed that both the TLC diet with and without legumes had favorable effects on some cardiometabolic factors; however, compared with the TLC diet without legumes, consumption of @ TLC diet with legumes for 8 weeks significantly improved FBG, insulin concentration and some disturbances. in lipid profiles in overweight type 2 diabetes patients, This may be ‘explained in part by comparison of the nutrient profiles between the two diets. For example, legume diets had higher concentra. tions of magnesium and fiber and a lower concentration of cholesterol they are known to be associated with decreased levels, ‘of cardiometabolic risk factors and to improve diabetes and insulin resistance."*"" The National Institute of health considers serum total choles: terol and cholesterol lipid fractions LDL and HOL as valid biomarkers for the risk of cardiovascular disease.”” Triglyceride concentrations are also relevant, as indicators of cardiovascular disease risk in diabetes patients.” in the current study, compared, with the TLC diet without legumes, the legume-based TLC diet had beneficial effects on serum concentrations of total cholesterol, LDL cholesterol and trilyceries in type 2 diabetes patients these results are consistent with the results of previous trials demon- strating thatthe ingestion of legumes has a cholesterol-lowering effect. n a clinical study, incorporation ofa 15 serving of legume in a high-fiber and lowglycemic index diet for 4 weeks decreased total cholesterol, LOL cholesterol and tiglyceride concentrations, by 10-148.” In addition, among obese participants, calorie restricted legume-based det for 8 weeks decreased weight, serum TC and LDL-C.” Crujeras et ak reported that an addition of four Servings of legumes/week to a hypocaloric diet for 8 weeks led to improvements in both total cholesterol and ox-LDL cholesterol, malondialdehyde and urinary @-so-PGF2a. ‘The reduction ‘observed in LDL cholesterol is consistent with that reported in 2 previous meta-analyses of 26 randomized controled trials of the effect of dietary pulses (beans, chickpeas, lentils and peas) on ‘ardiovascular risk factors, which concluded a significant redue- tion in LDL cholesterol of 0.17 mmol at a median dose of 130 9/4, ‘of pulses fabout one serving daily) over a median follow-up of 6 weeks.” Most of the previous studies investigate the effect of legume in the framework ofa hypocaovic diet” inthe current study, we found that dietary advice on replacement of two Servings of red meat with legumes for 3 days per week in an isocaloric TLC diet had beneficial effects on disturbances of lipid profiles in diabetes patients, independent of SMI change. {© 2015 Mocmilan Publishers Limited Legumes intake and carlometabolc rik factors 5 MosseinpourNiazi et af Table 2. Means of cardiometabolic factors at bassline and after 8 weeks of intervention in type 2 dlabetic patients" Conuel de? LequmetaseaTicae® n aH 3 ‘Bm thy’) Baseline 278206 27706 ost End of tial 27906 272406 oor Change 0.06204 “ons? 018 Waist circumference fom) Baseline 965216 971225, 010 End oftial 97.14 14 952428 037 Change 13229 35418 033 58 fe Ha) Baseline 136204 125402 ost End of tial 13203 120403 oo Change 08203, 0a +03, 090 108° (men Ha) Baseline 1203 78201 032 End of tial 7.7202 75203 05 Change 04403 04403 069 786 (mg/ad Baseline 1476296 14332100 on End of tial 128.1289" mase73* 001 Change 195555 28767 <0001 esting Insulin (ue) Baseline 75207, ais06. 0.426 End of tial 60x05 45z03 aon Change 15205 35204 0.006 To ima/ay Baseline 14404105, 1510299 028 End of tial 12454 105% 12263 1064 003 Change -195264 385256 002 HOLE (nase Baseline 486227 473224 034 End of tial 46926 480826 oa Change 17213 osas12 023 10L¢ rman Baseline 9785.4 100: +56 039 End of tial 89.1452" 794550° O08 Change -87 227 = 1562541 02 Total cholestrel img/ap Baseline 1792266 744272 oat End of tial 1615270 156163 030 Change 177249) a ra3354 ost ‘Abbreviations BM body mass index DBP, diastole blond pressure FG, faxing blood glucose; HDL, highdenlly Hpoprotein LDL, low-density lipoprotein; SB, systolic blood pressure; TG wiglyeride; TLC Therapeute Lifestyle Changes Data ate mean =e. "The conta det was a legume free TLC det. "Te legume based TLC cet was the some 9 the contol det, bt two Servings of rel meat was replaced with diferent types of cooks legumes such as lets, chickpeas, pees end beans, 3 doy per week #005 compared with basen. Legumes are a good source of soluble fiber, which have been shown to have cardiometabolic protective effects, and are believed to bind to bile acids in the intestines and prevent reabsorption into the body. Consequently, an increase in the production of bile aids decreases the lver pool of cholesterol and increases the uptake of serum cholesterol by the liver, thereby decreasing circulating cholesterol in the blood.” In addition Fropeon Journal of Clinical Nutriion (2015) 592-597 595596 Legumes intake and cardiometabolc rk factors 5 MosseinpourNazi et a! specific phytochemicals such as phytosterols may reduce cardio- vascular disease by lowering blood cholesterol concentrations.” in the current study, replacement of red meat in the TLC diet by legumes-improved concentrations of glucose and insulin among ‘overweight diabetes patients, independent of BWI change. Some. previous studies investigating the effects of legume inclusion In the diet on biomakers of insulin sensitivity and diabetes have documented conficting results." In a cinical tal, incorpora- tion of 1 cup of legumes as part of a low-lycemicindex diet improves HDAC in diabetes patients In another study, inclusion ‘of chickpeas in the habitual ad libitum intake of 45 healthy participants for 12 weeks resulted in a reduction in serum total ‘cholesterol, fasting insulin concentration and homeostasis mode! fof assessmentinsulin resistance: In a cross-sectional study of non-diabetes participants, substituting a serving of total red meat intake with altermative protein food in a combination of poultry, fish, legumes and nuts was associated with, significantly lower fasting insulin, HbATC and C-reactive protein’” A previous meta- “analysis of 39 trials showed that pulses, alone or in low-Gl or highs fiber diets, improved markers of longer-term glycemic control in, humans. Pulses alone (11. trials) lowered FBG (-082, 95% confidence interval (Cl ~ 136 to ~0.27) and insulin (-049, 953%, 1-083 to ~004). Pulses in low-olycemic:index diets (19 tal) lowered glycosylated blood proteins (GP), measured as HbA\< of fructosamine (028, 95% Cl 042 to ~0.14). Finally, pulses in high-fiber diets (11 trials) lowered FBG (-032, 98% Cl -049 10 =0.15) and GP (-0.27, 95% Cl ~0.45 to ~0.08). In addition, 2 large prospective study shows that @ traditional Mediterranean food pattem, whichis rch in plant-based foods such as legumes, is associated with a significant reduction in the risk of developing type 2 diabetes." However, others found no beneficial effects: Hartman et al2® found that high-legume diet did not improve insulin sensitivity and inflammation after a 4-week intervention ‘compared with a healthy American diet among insulin resistance participants. In another study, compared with whole-grin-based {o0ds, inclusion of 140g of chickpeas in the diet did not improve insulin sensitivity, insulin and homeostasis model of assessment- insulin resistance and glucose concentrations among healthy participants” Comparison of the legume-based diet with healthy diet such ag the healthy American diet ** and whole- ‘rain-based foods * may explain the non-significant effect of iegumes on insulin sensitivity. In the current study, the legume- based TLC diet had a more beneficial impact on glycemic contol more fiber, magnesium, phytoestrogen and isoflavone intakes ‘owing to legume consumption might be responsible for these. effects!" Besides abnormalities in lipid metabolism, elevated. blood pressure is another cardiometabolic risk factor among diabetes patients. the current study, neither the TLC diet nor the TLC diet ‘with legumes had significant effects on systolic or diastolic blood, pressure, Previous tials examining the effect of legume con- sumption on blood pressure reported conflicting results. Some tials did not observe significant decreases in systolic and diastolic blood pressures after inclusion of legumes to, the diet among peripheral artery disease and obese subject:”>? however, others have found improvements in biood pressure resulting from the addition of legumes to the diets of obese or hypertensive patients "°° Given the variability in the findings of these trast femains unclear whether legume consumption improves blood pressure, and in which population or at what amounts a benefit may be conferred. To. mention limitations, inthe present study, we only recommended the types of intervention diets to be consumed, ‘and no particular pre-prepared diets were given to participants: therefore, the diets may not have been followed as carefully a5 in, tials in which prepared food was provided. In addition, owing to 2 limited budget, we could not measure the biochemical indices of lequme intake in this project. and compliance of participants was European Journal of Clinical Notetion (2015) 592-597 assessed by analyzing the 3-day diet selfsrecord. However, our results suggest that compliance of legume-based TLC diet could have benefits on cardiometabalic risk factors. The rate of non ‘compliance was also a imitation in the present study. About one fourth of the study participants were lost to follow-up, which might be considered another limitation ofthis study: however, this ‘was a cross-over trial, and cross-over trials are usually caried out ‘over 2 longer time period, which results in a greater number of patient exclusions, However, after analysis of data for both ‘compliance and non-compliance of participants, no difference ‘was shown with analysis of compliance participants. In addition, the rate of non-compliance in the lequme-based TLC diet and ‘control diet was the same, and thus compliance did not difer. Furthermore, because this vas a dietary intewvention, patients and investigators were not blinded. ‘CONCLUSIONS Dietary advice for diabetic patients on the substitution of red meat ‘ith legume intake within 2 TLC dietimproved glycemic control and lipid profiles such as triglycerides, total and LDL cholesterol, independent of any BMI change. CONFLICT OF INTEREST ACKNOWLEDGEMENTS “The author acknowledge Ms N Shia for ral eng of Engin granenar aed syntax ofthe mananipt Tita funded by gan no. 4 rr he earch Insite for Endocine Sciences, shat Sehesne Unvesty of Modal Scenes, AUTHOR CONTRIBUTIONS “The prcjct idea for this study was from SH. The project was designed by PM, SH and FA SH, and MH analyzed and Interpreted the data; SH and PPM prepared the manuscpt. Al authors read and approved the final manuscript Over FA superised the project and approved the final version ofthe manuscript to be submitted REFERENCES 1 Kalfotis Pipa Kallas, Har F PhosniO,Sogh J. Type Wabetes tmalftr ae canons ek faces cent therapeu speach. xp Gt 2 te OL, Canin A Ra meat: etry heme on an ak of ype 2 sabes: the mvaivement of a6ranced lpoudtion end products. 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J Agri Food (hem mor $5: 7981-7994, 25 Jenins Kendal CW, gsi 1S Atchel 5, Saye Paden S Blanco Maja tol Ec of aque sp of aoa gcemic index ton hci conto, feeb carioveses sk actos in type 2 dlabetes metus @ randomized rire ial chine Med 2012 12: 1653-1080, 26 Pauay Ronson x, Sal ML. Chickpeas may ifence fay 2 ad ee Inte ha at Set lean to sal proves in etm pi peo 2rd gicemiecomtol J Am De Ae 208; 108. 1009-1013, 27 Lay SH Sun Wilts WC, Eason AH Wu K, Pan Ae socio between red meat infle.and biomarker of infmation and ivcre metabolem Im women. A Jl hu 214; 9: 352280. 28 Haran Uber PS, Zhang 2. BaashowD, KA heron PM Ubrech eta Consumption ofa legume envched lowgleamie der cet asceated vith omarlers of iniuin resitnce ond ivlammation among men at sk for colorectal cance J Nw 2010, 140 60-67. 29 Net! P.Cehun Chrous A fects of lngterm consumption ae single meas of chika on psa glucose ns and wagered concertos. 20 Sevenpiper I, Kendall CW, Esfahan A, Wong JM, Carton Ak Sang HY et a Sect of nonci-seed pubes on Gycaenic contol asystenati fee and et uly of ardoized contol exparmental ian peopl ith a whut (taoaes. Cabrio 200 521479195. Narinee-Gonsier 16h, de Io. FuenteAribga Nunes Cordoba Jt astera Gort, Seuea J Yanquer Zeal Adberence to Meateranean det tee tak of devioping betes prospective cohort sty. BM 2008) 336 1348-1381 32 ZahvadiaP Wight 8, WeighelW leet HBalduin A, 0 Ket al Dall nonsoy legume cnsumpion reverses vascusr mosiment due © parpterl ane ce, Ahersclass 2013230: 310-314 53 Rowe L Para D, Mariner IK Legume, fof high protein aie hypoclerie ‘des effects on wight loss and mtochonalondton in obese ron Med Food 2008 1200-108. 24 Toxat J, Nisin &, Johanson M, Bick L. 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