SYSTEMATIC ASSESSMENT OF AN EPIDEMIOLOGIC STUDY Title: Vegetarian compared with meat dietary protein source and phosphorus homeostasis

in chronic kidney disease. Author(s): Moe SM, Zidehsarai MP, Chambers MA, et al. Volume: 6 !" P !es: !#$%6& Ye r: !'(( Li"# to Arti$le: http)**c+asn.asn+ournals.org*content*6*!*!#$.long INT%ODUCTION: %e&ie' o( liter ture ,he authors o- this article state that the purpose o- this study was to determine i- dietary protein sources o- phosphate in-luenced phosphorus metabolism and hormonal changes in humans because this would a--ect dietary recommendations -or patients with ad.anced C/0. % tio" le ,he authors o- this article acknowledge the recommendation to restrict dietary phosphate intake to 1''mg*d -or patients with ad.anced C/0, but also suggest that protein sources o- phosphate may be osigni-icance when considering phosphate balance. ,he ne2t logical step is to conduct a research study to test the e--ect o- protein sources o- phosphorous on phosphorus balance in patients with ad.anced C/0. )*+otheses or O,-e$ti&es ,he ob+ecti.e o- this study was to determine i- dietary protein sources o- phosphate in-luence phosphorus metabolism and hormonal changes in patients with C/0. STUDY DESIGN AND MET)ODS Desi!": Ge"er l ++ro $h: 0escripti.e testing conducted. Le&el o( me sureme"t: Measurement was conducted at the indi.idual le.el. S+e$i(i$ .esi!": ,his was a cross%o.er trial.

Po+ul tio" t %is#: ,he population -rom which the study sample was selected was indi.iduals with stage late 3 or stage & C/0 with a mean e456 75 3!.3 8*%6 m9*min and normal serum phosphorus. :ndi.iduals were men and women with a mean age o- 6( 8*%1.& years old and mean ;M: o- 3! 8*% # with one <ispanic participant. S m+li"! Metho. ". S m+le Si/e: :ndi.iduals were recruited -rom nephrology clinics and asked to participate i- they met inclusion criteria. ,he sampling method was not speci-ied by the authors. ,he resulting sample si=e was 1 participants. Sele$tio"
:nclusion criteria were)

". E0$lusio" Criteri

(or Stu.* Grou+:

age > (1 years e456 !' to &# ml*min by modi-ied -our%parameter Modi-ication o- 0iet in 6enal 0isease e?uation urine protein*creatinine ratio @ # blood pressure @ (#'*A# mm<g not taking calcium binder or supplements, .itamin 0, or phosphate binders normal serum phosphorus and calcium corrected -or albumin and intact parathyroid hormone P,<" @ ('' pg*m9 medically stable able to gi.e in-ormed consent and come -or all .isits Anyone who -ailed to meet inclusion criteria was e2cluded -rom the study. Participants meeting inclusion criteria were admitted to the :ndiana Clinical 6esearch Center -or the duration o- the study which was one week. Potential selection bias may ha.e occurred as the article does not speci-y what nephrology clinics the participants were selected -rom and $ out o- 1 participants were Caucasian. De+e". "t & ri ,le: According to this articleBs study ob+ecti.e, the dependent .ariable was the phosphorus metabolism and hormonal changes in patients with C/0. Patients collected a !&%hour urine sample the day be-ore beginning dietary inter.ention.

,he same collection system was used again during the :C6C stay in which !m9 urine was collected at each collection time and analy=ed separately. ,he remaining urine was pooled -or a !&%hour urine assessment to be compared with baseline .alues. Crine was e.aluated using 9itholink -or urine phosphorus, creatinine, sodium, uric acid, citrate, ammonium, protein%to% creatinine ratio, and sul-ate. ;lood was also analy=ed -or intact P,< using 0iaSorin !6('' :6MA and intact 545!3 by batched analyses at the end o- the study Vitamin 0!803 was analy=ed by li?uid chromatography*mass spectroscopy and li?uid chromatography* tandem mass spectroscopy. I".e+e".e"t V ri ,le: ,he key independent .ariable o- this study was dietary protein sources o- phosphate which were classi-ied as either meat (casein) or vegetarian sources. 0iets measured to be !!''kcal with (''mg calcium 3'''mg sodium with target phosphorus (!''mg*d and initial goal o- !'D protein with use o- a so-tware program. 7nce the -ood was -ormulated, it was -ro=en, treated with a preser.ati.e, and the phosphorous content was analy=ed. ,he phosphorus content o- both the meat casein" and .egetarian diets measured 1'' mg per day. All -ood was prepared by :C6C sta-- and gi.en to the sub+ects. Pote"ti l Co"(ou".i"! or E((e$t1Mo.i(*i"! V ri ,le: M #e list o( these2 i"$lu.i"! those th t h &e uthors h &e $o"si.ere. +lus other *ou thi"# m * ,e im+ort "t3 Grou+ them i" 4 $ te!ories: Co"trolle. ,* stu.* .esi!" (,* m t$hi"!2 r ".omi/ tio"2 et$3) age e456 baseline lab .alues

blood pressure medications, supplements causes o- C/0 comorbidities Co"trolle. ,* " l*sis ,o determine whether the e--ect o- dietary source oprotein was dependent on the order in which the diets were assigned, models including the interaction between period and dietary source were tested -irst. Not $o"trolle. ,he authors do not speci-y what, i- any, potential con-ounders were not controlled -or and the reader did not identi-y any.

I"(orm tio" 5i s Co"trolle. ,* Stu.* Desi!": Participants were randomly assigned to either the meat (casein" diet group or the vegetarian diet groupE howe.er, the study as not double or triple%blind which may ha.e resulted in bias. %ESULTS Missi"! D t : Fle.en patients were consented and two -ailed screening because o- e456 greater than the inclusion criteria. Gine patients were enrolled and one patient dropped out a-ter the -irst arm othe study due to hunger. Fight patients completed both arms consisting o- -our men and -our women and they were -urther analy=ed. ,he authors o- this article report that the dietary compliance was high based on a -ood -re?uency ?uestionnaire that was used. M -or Fi".i"!s: ,here was a signi-icant correlation between the change in plasma phosphorus concentration and the change in 545!3 r H '.#&, P H '.'3" ,here was a signi-icantly higher a.erage plasma 545!3 ('(pg*dl .ersus 6(pg*dl, PH.''1" with the meat%based diet compared with the .egetarian diet. ,here was a signi-icantly higher a.erage serum phosphorus 3.6 versus 3.3 mg*dl, P @ '.'''(", calcium A.( versus 1.1 mg*dl, P H '.'''(", and 5ePhosph !& versus (1D, P H '.'''(" and lower

P,< && versus #! pg*ml, P H '.'''!" with the meat%based diet compared with the .egetarian diet. Co"trol (or Co"(ou".i"!: AgeE e456E blood pressureE certain laboratory .aluesE and calcium binder or supplements, .itamin 0, or phosphate binder were all controlled by study design in the inclusion criteria. ,he cause o- C/0 was identi-ied in the participants and it was hypertension in one sub+ect, diabetes in two sub+ects, 4G in one sub+ect, urologic abnormalities in two sub+ects, and cause was unknown in two sub+ects. Comorbid conditions were identi-ied in the participants and included diabetes in -our sub+ects and hypertension in si2 sub+ects. Participants on certain medications were identi-ied. 5i.e were on diuretics and three sub+ects were on angiotensin con.erting en=yme inhibitors or receptor blockers. ,he authors o- this study article did not identi-y and con-ounders in the study. St tisti$ l A" l*sis: Authors o- this article calculated that an 1'D power would re?uire n H # to determine di--erences in phosphaturia and n H 1 to detect di--erences in 545!3. ,he comparisons o- blood and urinary measures a-ter ( week ooutpatient diet was analy=ed with paired t tests 6egressions were calculated using Pearson Product Moment. 5or the :C6C !&%hour inpatient studies, the outcomes were analy=ed using linear mi2ed%e--ects models to compare the o.erall le.els o- each o- the .ariables during the !&%hour inpatient time period. A signi-icance le.el o- I H '.'# was used -or statistical tests. DISCUSSIONS AND CONCLUSIONS I"ter" l V li.it*: Although participants were randomly assigned to either the meat (casein" diet group or the vegetarian diet group, the study as not

double or triple%blind. ,he reader belie.es that this negati.ely impacts the internal .alidity o- the study results. E0ter" l V li.it*: ,he authors o- this article acknowledge the small sample si=e and short duration o- this study and the reader belie.es that this negati.ely impacts the e2ternal .alidity o- the results. Additionally, Se.en out o- eight participants were Caucasians and there-or the results o- this study cannot be e2trapolated to other populations.

Co"siste"$* 'ith Other Stu.ies: Do the uthors ttem+t to i"te!r te the results 'ith those o( +re&ious stu.ies6 7h t (i".i"!s re i"$o"siste"t6 The uthors o( this rti$le re+ort +re&ious stu.ies ,he authors o- this study report that the results o- this study are consistent with the -indings in another se.en week crosso.er study that reported signi-icantly decreased serum phosphorus le.els in participants who -ollowed a .egetarian diet when compared to those who -ollowed a meat based diet. Theoreti$ l Im+ort "$e o( %esults: Do the results .. "*thi"! to e0isti"! #"o'le.!e ,out the +ro,lem u".er stu.*6 )o' mi!ht these results ((e$t +u,li$ he lth6 ,he results o- this study do not add anything to e2isting knowledge about the problem under study. ,he results o- this study will most likely not a--ect public health at this time. <owe.er, they may stimulate -urther studies regarding this sub+ect matter. Pr $ti$ l Im+ort "$e o( %esults: As result o( this stu.*2 shoul. i".i&i.u ls or !e"$ies .o "*thi"! .i((ere"tl* (rom ,e(ore6 ,his study :ndi.iduals or agencies should not do anything di--erently based on the results o- this study. <owe.er, it may be bene-icial to educate patients with C/0 on plant and animal sources or protein and continue to educate on hidden sources ophosphorus as the article mentions. Further Stu.*:

,he authors o- this study suggest that, due to the studyBs small sample si=e and short duration, larger studies are needed to determine i- dietary protein

sources o- phosphate in-luence phosphorus metabolism and hormonal changes in patients with C/0. ,hey suggest that i- the results o- this study are con-irmed in longer studies, then they will pro.ide a rationale -or recommending a predominance o.egetarian sources o- protein to patients with C/0. ,he authors o- this article did not appropriately acknowledge the higher biological .alue o- protein -rom animal sources or the current recommendations -or protein consumption in C/0. ,he reader suggests that the suggested recommendations may be con-licting with current e.idence and e.idence based practices regarding MG, -or C/0.