Juniper Online Journal of Case Studies
tshtaetudsuroartmionedoicf atthieonsstuwdeyr. eArneycosyrdmepdt.oms and changes in health Statistical analysis Subjects were randomized by a computer-generated ss ct ahtei sdtui cl ea l taon aeliyt sheesr wt heer e a cc at irvrei e do r o uptl a cuesbi nog gSrPoSuSp sVe(r2s:i1o)n. A2 4l l f5o%r Wl e vi ne dl oowf ss .i gAn li lf i ct ea sntcse . wCeorhe e nt w’ s ods i dweads auns edd pteor fdoertme remd i na et tt hh ee setf rf eecntg: t0h ≤( s tda n< d0 a. 2r;dSi sme da l ml eefaf encdt :i f0f e. 2r e≤n cde <) o0f . s5t;aMt i setdi ci ua ml r eesfuf el tcst : 0N. 5o ≤s udm<m0a. r8i;z Le da r gbey e mf f eecatnds ≥o f0 . 8a b[s1o6l ]u. tCe a tneugmo rbi ec rasl . p Na ruammeertiecrasl wd ea rt ae wa veari el asbul me dmaat rai, zme de abny , ms teaanndsaor df sdt aenv di aatri od ns ,t amt ii sntiimc su(mi . e, .m, nauxmi mb ue mr o)f. The change in subject’s measurements (WOMAC scores; SF- 36v2; SPPB) between treatment groups from baseline to the end o( wf ti trhe at thme ea np tp rwoeprrei aat ne at leyszt eodf nu os irnmg aal i trye, pheoamt eodg emneeai tsyu roef sv aArNi aOnVcAe at rneda t smpehnetr-ircei tl ay t ecda rardi evde r os eu te vi ne int ti as l lwy )a.s Tc ho em po av reer da l la ci nr oc si ds egnrcoeu posf by Fisher’s exact test and the chi squared test. Measurements Analysis of WOMAC scores, SF-36v2 and SPPB were based on [w1o7r- s1e9 ]p, ar iens, psetci ft fi vn ee lsys. , Tahned h fi ug hn ec tri os cnoa rl elsi mo ni t at thi eo nWs O[ M2 0A] C. Ti nhde i cSaFt 6e 36 consists of eight scaled scores, which are the weighted smuomr es od fi stahbei l qi tuy e[s1t i8o]n. sI ni nr et lhaet ii or ns et cot itohne. STPhPeBl ot we set r, ht hi geh secr osrceo trhe es it nh de i cs at ut ed yb eatstseers sl oewd eera cbho dsyu bf uj encct t’ si o- rne p[ 2o 1r t]e. dT haed vcel irns iec aelv teenatm( Af Eo r) aAnc dt i ocna tteagkoerni z; eOdu ti tc oamc ceo;rSdei nr igo ut os IAndt ev ne rssi teyE; vReenl at t(i SoAn Es h) .i p t o s t u d y ; Results Exploratory analysis on the effect of 8 weeks’ supplementation of specific fish collagen peptides (Naticol ® ), on osteoarthritis measurements, for subjects that completed the study With the exception of gender, there was no difference in ss uu bb jj ee cc tt sf raocmr o es sa cthr etar tema temn et ngtr og ur opus pa ht abda st er el iantem, es en et dTiasbc loen 2t i.nOu ne de dt huee ptroo dnuacut s(epal a (caecbtoi v eg r ogur opu) ,p )s e ea nTda bal en 3a. l l He regni cc e ,r eraecstui lotns ot no mstueadsyu–rei.me.e, 9n:t1s9aPrleacreebpoo:rAtecdtivoen. subjects that completed the
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of the target knee were included. The study occurred between M( l aasyt s9u, b2j0e 1c t7, l (afsi rt svti ssi ut )b. jBe ac ts ,e df i rosnt fvi ni sdi ti )n gasn fdr oDme cKeummbaerr e1t 2a ,l . 2[ 10 51 ]7, 3w0e rs eu br aj encdt so mw el yr ea sr sa ingdnoemd itsoe dt hi en tpol aocneeb oo f gt wr oou gp r, owuipt hs . 21 00 ss uu bb jj ee cc tt ss to the active group - i.e., receiving the investigational product (Naticol ® , fish collagen peptides). The investigational product (NATICOL ® , fish collagen peptides) was manufactured and rt oe l etahsee d Cuonodredri nt ha et orre/sIpnov ne ss ti bi gi al i tt oy ro f i Wn e bi sohxaersd t caonndt awi na isnpgr osvi indgel de dose sachets. A 10g sachet of the investigational products and tohnee cdoami l yp ai nr at at okre pi nr o2d0ucclt o(fmcaolltdo dl ieqxut irdi n()f rwu ietr ej u it coe ,b me icl ok nosru mc oel dd tea) 15 minutes before breakfast, for 8 weeks. The Naticol® reveals the presence of numerous amino acids including proline, hvayldureoxisyaplrsoolisnuem, gmlyacriinzeedainndTaabrglein1i.ne, see Table 1. Nutritional At baseline, subjects were provided with a box containing 8-weeks supply of the study product, along with an additional 4-day supply in case of loss. Subjects were instructed to one sachet each morning, with their breakfast, for the duration of the study. Subjects returned after 8 weeks. At each visit the vitals, anthropometric measurements, concomitant medication at hned f oa nl l yo wai dnvge rqsuee set vi oennnt sa i rwe es :r eWreesct oe rr dn e Od .n tSaur bi oj e ac tnsd cMo mc Mp al estteedr Up anri tviecri ps iat ni et sg lOo bs tael oaasrstehsrsi mt i se nItnsdheoxr tLfiokremr t 3S6c(aSl eF - 3( W6 vO2M) . AS uC b) j eacntds returned any unused study product and compliance was au snsdeesrswe de nat ntdh enSehwo rst t uP dh yy s ipcraol dPuecrtf oardmma innci es t Be raet dt e. r Sy u(bSjPe Pc tBs) at el ssot ad ti eet a ac hn dv i es xi te. rScui sbej ercot su twi neer ea innds t nr uo ct t ec do ntsou fmo lel omw etdhi ec iart isotna sn dt ahradt could interfere with the assessment of the study product for
How to cite this article: Seán Lacey, Christelle Bonnet, Kelly Seamans, Andrea Doolan. Effect Size Statistics to Inform an Exploratory Analysis of a Double-Blinded, Randomised, Placebo Controlled Pilot Clinical Study to Evaluate the Efficacy of Naticol ® , Specific Fish Collagen Peptides to Alleviate Symptoms of Osteoarthritis in the Knee . JOJ Case Stud. 2019; 10(2): 555783. DOI: 10.19080/JOJCS.2019.10.555783 0032 Table 2: Count of subject demographics, along mean ± SD [Min, Max] of vital signs, anthropometric measurements at baseline. Placebo Active p-value n 10 20 Male:Female 0:10 2:18 <0.001* Age (years) 62.3± 6.31 [51, 73] 60.4± 6.98 [39, 72] 0.463
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