Effect Size Statistics to Inform an Exploratory Analysis of…

Juniper Online Journal of Case Studies

iwmhpi lreo vt he ed souvbej re ctths ei n8 t hwee ae cktsi v(edg =r o 0u .p0 7i mapnrdo v0e.d1 5i n, rbeostphe cc at isveesl y( )d, = -0.18) and 0.09, respectively). SPPB Noting higher scores indicate better lower body function [21]. Hence, a negative effect size (Baseline – Week 8) represents an improvement in lower body function over the 8 weeks. Both gTroot aulp ss c oerxep. eWr i ehni lcee dt h ea np l ai mc epbroo vgermo uepn te xi pn e rtiheen cCehdaai r s mt eas ltl aa nn dd nwehgi ll ieg ti bh lee a ci mt i vper ogvr eomu pe ne txsp e(rdi e =n c e- 0d. 2a 5s ma na ldl i m- 0p. 1r 0o ,v erme sepnetcitni vbe ol yt )h, tneosttspr(des=en-0te.4d7inanTdabdl=e 5-0a.3n3d, Freigsupreect1iv(ce)ly. ). Gait score results are Adverse events Fisher’s exact test found there was a statistically insignificant association between the number of adverse events reported per vt hi seirt ea nwd at sr e aat mset na tt i sgtrioc ua lpl y( p i =n s1i g. 0n0i 0f i )c,asnete Taas bs ol ec i3a.t Fi ounr t hbeertmwoe reen, tt ra ekae tnmaenndt gOruotuc po ma ne do tf haen: Iandtveenrssi et ye, vReenl at t(i po n=s h1 i. p0 0t o0 , s0t u. 8d9y4; , A0c. t6i 3o n8 and 0.051, respectively). Discussion This double-blinded, placebo-controlled pilot clinical study ds pe emc oi fni cs tf ri sa ht e cs ot lhl ae gpeont epnetpi at il df oe sr , oNnac tei cdoal i®l y, ot or aal ldl eovs ieast eo fs Ny ma t pi ct oo lm®s, oi nf onsat teuoraer, t ha rni dt i s eifnf e tcht e ski znee ec. aTl chuel asttiuodnys dsehsoi gwn twh aa st esxupbljoercat tso ri ny tt hh ee amc taijvoer i gt yr o ou fp me xepaes rui reenmc eedn tms ot rhea no f saunb j iemc tpsr oi nv e mt heen tp laaccreobsos gt hr oo suep oofv eprr et vhieo u8 s wpereekc sl i no ifc tahl ea ns tdu dc yl i. nTi chael s es t ur edsi ue sl t st oc oarsrsoebs os rtaht ee pp oh tyesni ct ai al lmeof bf ei lcittsy aosf acsos lel as sgeedn bhyytdhreo lWy seastteesr noOn n tj oa irni ot Mp ac iMn a satnedr Universities (WOMAC) scoring system. Clinical studies suggest that the ingestion of 10g collagen hydrolysates daily reduces pain in patients with osteoarthritis of the knee or hip while blood concentration of hydroxyproline is increased. Clinical use was associated with minimal adverse eufnfepcletsa,samnat itnalsyteg[a2s3t]r.ointestinal, characterized by fullness or In a prospective, randomized, double-blind, placebo- ckonne ter ool lsetde o as trut hdryi t iisn, oe rl da el r li yn t awkoe moefn c wo liltahg e mn i lpde- pt ot i dme so dfeorra t ae da nu dr a tiimo np roofv6e mp ho ynst ihcsa ls hmo wo beidl i ttyo saisg nai fsisceasnstel yd rbe yd utchee j oWi net spt eari nn Oc l ni nt ai crai ol sMt uc dMya sctoe nr f Ui rnmi veedr stiht iaets c(oWl lOa gMeAn C p) espc toi rdiensg as ryes t eamh. i Tg hh liys efficient nutraceutical to improve joint health in patients with osteoarthritis which can help to maintain an active lifestyle throughout ageing [24].

We can also indicate a double-blind, placebo-controlled, rpaonr dk o smkiizne d( P Ct rPi )a l a nwdi t hb o vc ionl el a gbeonn eh y( Bd Cr oPl)y ssaot ue sr c ei ss ocl aa trerdi e df roo umt tpoe pst ti du ed yt o t choe n terfof el ct thi ve epnreosgs r eosfs i oo nr a ol lfy o ss tuepopalretmh rei nt itse di n cpoaltl iaegnetns diagnosed with knee osteoarthritis. Improvement in treatment with reduction in WOMAC and quality of life (QOL) scores from baseline to 13 weeks were recorded. Indeed, all the score levels of WOMAC and QOL decreased significantly (p<0.01) in the study group compared to placebo group after week 13. Safety and tolerability were also good [15]. Additionally, research in mice has demonstrated that after oral administration of radiolabeled gelatin hydrolysate, the radioactivity was specifically found in cartilage indicating an accumulation of these peptides within the connective tissue [25]. The study demonstrated the intestinal absorption and cr oa rl et i l oa fg ec oa lcl ca ug me nu lha yt idorno loyfs ac toel sl a gi ne nr eppe apitri doef. Tdha umsa, gt eh de pc oa rt et inl at igael cc oo ul l ladg eb ne ahsysdorcoi laytseadt ewsi. t Ah trhe ec eanc tc ua mn i uml aa tl i sotnu od fy ohr aa sl l ya lasdoms ui ngi gs et es rt ee dd that oral ingestion of collagen hydrolysates 9 might have beneficial effects on joint health such as osteoarthritis (OA) as ca os sl loacgieant e hdy dwr iotlhy s ao tset es oma ri gt hh rt i triecd uc caer tti hl aeg em odrepsht roul oc tgiioc na l icnh aknng ee es joints, [26]. This mechanism about absorption, distribution and collagen pc lei np itci da lel ya rcec cuomr du el adt ioonn j ioni nctapr at iilna gaen dmpa hy yesxi cpal la imn otbhiel i tbye. nHeofwi t se vwe re, af onrt i b- iennf leafmi t sm. aI nt odreye dp, r ot hpee rl ti it ee sr a mt uar ye rael spoo rbt se tahna t a idndt irtai o- anrat li c uwl aa yr ao ds tme oi nairstthr raittiios n d eomf ocnosltlraagteend ai n s itghnei f i ckannete l oocfa l s iunbf jl ea cmt sm awt iiot nh decrease (increase in T regs, IL-10 and decrease in IL-1β) and a mitigation in the symptoms inherent to the pathology [13]. Similarly, oral administration of collagen hydrolysates in mice with post-traumatic osteoarthritis inhibited synovial inflammation and induced cartilage regeneration [12]. Moreover, in this pilot clinical trial study, we may indicate tt hh ae ts ftruodmy , t5h (e5258. 6 (%9 :)1o9f Pt hl aecpe lbaoc:e Ab oc t gi vreo)u spuabnj edc 1t s4 t (h7a3t . 7c o%m) pol fe tt eh de active group had a body weight greater than 70kg at baseline. From Table 2, the maximum weight of subjects (that completed the study) at baseline was 85.5kg and 100.0kg for the placebo and active groups, respectively. In Shigemura et al. [27], the daily ingested dose of collagen hydrolysates is linked to the bi nogdeys twe de i dg ho ts .eT/ hk ge sbeoaduyt hwoeri sg he tx aa mn di nf eo do dt h- dee rrei vl ae tdi ohnysdhriopx by ep trwo lei en ne loef vt ehles ci no l hl augme na np eppl at isdme sa. Ht oe ensctei ,mh ae tael tthhye veof lfue nc tt ieveer sb ei nngeef si ct ieadl 3d 0o .s8e, 1T 5h 3e . a8vaenr da g3e8p4l.a6smmga pceornkc ge nbtor da tyi owne oi gf hhtyodfr cooxlyl apgr eo nl i nhey dc or onltyasi anti ensg. peptides was dose-dependent, reaching maximum levels of 6.43,

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 0035

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