series gas chromatograph equipped w

series gas chromatograph equipped with a split/splitless mode injector, and a flame ionization detector. The injector and detector were maintained at 280 and 300C,respectively, and samples were analyzed by multilevel temperature programing in the range of 90–265 C with ultra high
purity grade helium as the carrier gas. The percent composition of fatty acids was calculated from the individual peak areas using appropriate standards. The procedure was
routinely validated by proficiency testing using GC/MS. The OS levels were calculated by adding the individual EPA, DPA, and DHA levels. The OI was determined as previously described [13]. Analyses of all other serum analytes, including TG, VLDL-C, IDL-C, LDL-C, HDL-C, apo-A, and apo-B, hsCRP were performed at Atherotech Diagnostics Lab (Birmingham, Alabama, USA), as described earlier [34]. Power and sample size Earlier randomized placebo-controlled studies have indicated that the administration of EPA or DHA therapy over a 6 to 7 week time period can result in an increase in blood LC n-3 PUFA levels of at least 47 % and a decrease in blood TG levels of 18–21 % [35, 36]. Assuming a mean baseline blood OS level of at least 3 % and a change in
standard deviation of 1.5 % within a given study stratum [37], a sample size of 40 subjects per study stratum (i.e. 20 subjects assigned to 6:1-OM3 therapy, and 20 subjects assigned to placebo) would result in a minimum power of 90 % to detect an increase in blood OS levels of at least 60 % in subjects within the 6:1-OM3 study arm relative to subjects within the placebo arm, at a significance level of alpha=0.05 [37]. Assuming a mean baseline blood TG levels of at least 1.58 mmol/L and a change standard deviation of 0.40 mmol/L within a given study stratum, the
proposed sample size of 40 subjects per study stratum (i.e.20 subjects assigned to 6:1-OM3 therapy, and 20 subjects assigned to placebo) would result in a minimum power of 95 % to detect a relative decrease in blood TG levels of at least 30 % in subjects within the 6:1-OM3 study arm relative to subjects within the placebo arm, at a significance level of alpha =0.05.
Data analyses At the conclusion of the study, the Clinical Trial Review Committee assessed the CRF for compliance with the protocol and subjects who ingested a minimum of 80 % of the assigned capsules were locked in. The tabulated data were then un-blinded and analyses performed on the ‘‘per protocol’’ subset of study. The median change and interquartile range in blood OS and OI levels over the 8-week period, as well as all secondary outcome measures was computed for each study subject and organized by subpopulations based on treatment group, and cohorts. Percent changes from baseline to week 8 were calculated for each treatment group (placebo and 6:1-OM3) and placeboadjusted median percent changes were then calculated. A two-tailed t test (unpaired) was performed using GraphPad Prism version 6.0 for Macintosh (GraphPad Software) to illustrate placebo-adjusted changes and significance was defined as aPvalueB0.05. Safety evaluation
The qualified principal investigators at each site evaluated patient health while remained blinded to the study treatment regiment. All adverse events, defined as ‘‘treatmentemergent’’ (TEAE), which occurred during the study period, were evaluated and classified as related or unrelated to treatment by the principal investigator. Each TEAE was recorded in an individual subject’s case report form at each clinic visit, through patient health evaluations, including a
questionnaire, physical examination, clinical laboratory test evaluations, weight, and BMI. Reports were compiled, and categorized based upon grade, severity, and relationship to study treatment. The Clinical Trial Review Committee reviewed the subjects’ case report forms, and agreed with the principal investigator’s assignments.
Results
Study description and demographic characteristics of the enrolled subjects The study protocol outline is shown in Fig.1. Of the 655 screened, 509 subjects were ineligible for study enrollment as per inclusion/exclusion criteria in the methods section. The remaining 146 subjects were stratified into two Cohorts and were randomized, blinded and treated with
either corn oil (A) or 6:1-OM3 (B). Thirty-six subjects were either lost to follow-up or the compliance with the treatment was less than 80 %. The OS data from the 655
screened subjects showed LC n-3 PUFA nutritional deficiency was prevalent in general US population, with 89 % of subjects falling below 6.1 % OS (median OS 4.48 %; range 1.84–5.89 %). The baseline characteristics of the enrolled and randomized study population (Table1) were comparable within Cohorts, and across treatment groups with approximately equal numbers of males and females enrolled. The median baseline LC n-3 PUFA level (measured as OS or
OI) or mean serum TG levels were comparable among two Cohorts and treatment groups. The mean BMI was[30 (obese) for all groups and Cohorts. Statin use was also

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seri gas chromatograph dilengkapi dengan injeksi split splitless modus, dan api ionisasi detektor. Injeksi dan detektor yang dipertahankan di 280 dan 300 C, masing-masing, dan sampel dianalisis oleh programing bertingkat suhu dalam kisaran 90-265 C dengan ultra tinggikemurnian kelas helium sebagai gas pembawa. Komposisi persen asam lemak dihitung dari luas puncak individu yang menggunakan sesuai standar. Prosedur inirutin divalidasi oleh kemampuan pengujian menggunakan GC/MS. Tingkat OS dihitung dengan menambahkan tingkat individu EPA, DPA, dan DHA. OI ditentukan sebagai dijelaskan sebelumnya [13]. Analisis dari semua analytes serum lainnya, termasuk TG, VLDL-C, IDL-C, LDL-C, HDL-C, apo-A, dan apo-B, hsCRP dilakukan di laboratorium diagnostik Atherotech (Birmingham, Alabama, AS), seperti dijelaskan sebelumnya [34]. Kekuatan dan sampel ukuran awal acak placebo-dikontrol studi telah menunjukkan bahwa administrasi EPA atau DHA terapi selama 6 sampai 7 minggu periode waktu dapat menyebabkan peningkatan kadar darah LC n-3 PUFA setidaknya 47% dan penurunan kadar TG darah 18-21% [35, 36]. Dengan asumsi tingkat darah OS dasar yang berarti minimal 3% dan perubahanstandard deviation of 1.5 % within a given study stratum [37], a sample size of 40 subjects per study stratum (i.e. 20 subjects assigned to 6:1-OM3 therapy, and 20 subjects assigned to placebo) would result in a minimum power of 90 % to detect an increase in blood OS levels of at least 60 % in subjects within the 6:1-OM3 study arm relative to subjects within the placebo arm, at a significance level of alpha=0.05 [37]. Assuming a mean baseline blood TG levels of at least 1.58 mmol/L and a change standard deviation of 0.40 mmol/L within a given study stratum, theproposed sample size of 40 subjects per study stratum (i.e.20 subjects assigned to 6:1-OM3 therapy, and 20 subjects assigned to placebo) would result in a minimum power of 95 % to detect a relative decrease in blood TG levels of at least 30 % in subjects within the 6:1-OM3 study arm relative to subjects within the placebo arm, at a significance level of alpha =0.05.Data analyses At the conclusion of the study, the Clinical Trial Review Committee assessed the CRF for compliance with the protocol and subjects who ingested a minimum of 80 % of the assigned capsules were locked in. The tabulated data were then un-blinded and analyses performed on the ‘‘per protocol’’ subset of study. The median change and interquartile range in blood OS and OI levels over the 8-week period, as well as all secondary outcome measures was computed for each study subject and organized by subpopulations based on treatment group, and cohorts. Percent changes from baseline to week 8 were calculated for each treatment group (placebo and 6:1-OM3) and placeboadjusted median percent changes were then calculated. A two-tailed t test (unpaired) was performed using GraphPad Prism version 6.0 for Macintosh (GraphPad Software) to illustrate placebo-adjusted changes and significance was defined as aPvalueB0.05. Safety evaluationThe qualified principal investigators at each site evaluated patient health while remained blinded to the study treatment regiment. All adverse events, defined as ‘‘treatmentemergent’’ (TEAE), which occurred during the study period, were evaluated and classified as related or unrelated to treatment by the principal investigator. Each TEAE was recorded in an individual subject’s case report form at each clinic visit, through patient health evaluations, including aquestionnaire, physical examination, clinical laboratory test evaluations, weight, and BMI. Reports were compiled, and categorized based upon grade, severity, and relationship to study treatment. The Clinical Trial Review Committee reviewed the subjects’ case report forms, and agreed with the principal investigator’s assignments.ResultsStudy description and demographic characteristics of the enrolled subjects The study protocol outline is shown in Fig.1. Of the 655 screened, 509 subjects were ineligible for study enrollment as per inclusion/exclusion criteria in the methods section. The remaining 146 subjects were stratified into two Cohorts and were randomized, blinded and treated witheither corn oil (A) or 6:1-OM3 (B). Thirty-six subjects were either lost to follow-up or the compliance with the treatment was less than 80 %. The OS data from the 655screened subjects showed LC n-3 PUFA nutritional deficiency was prevalent in general US population, with 89 % of subjects falling below 6.1 % OS (median OS 4.48 %; range 1.84–5.89 %). The baseline characteristics of the enrolled and randomized study population (Table1) were comparable within Cohorts, and across treatment groups with approximately equal numbers of males and females enrolled. The median baseline LC n-3 PUFA level (measured as OS orOI) or mean serum TG levels were comparable among two Cohorts and treatment groups. The mean BMI was[30 (obese) for all groups and Cohorts. Statin use was also

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kromatografi gas seri dilengkapi dengan mode split / injector tidak pisah, dan detektor ionisasi nyala. Injektor dan detektor dipertahankan pada 280 dan 300? C, masing-masing, dan sampel dianalisis dengan multilevel programing suhu dalam kisaran 90-265? C dengan ultra tinggi
kemurnian kelas helium sebagai gas pembawa. Komposisi persen asam lemak dihitung dari luas puncak individu dengan menggunakan standar yang sesuai. Prosedur ini
secara rutin divalidasi oleh uji profisiensi menggunakan GC / MS. Tingkat OS dihitung dengan menambahkan individu tingkat EPA, DPA, dan DHA. The OI ditentukan seperti yang dijelaskan sebelumnya [13]. Analisis semua analit serum lainnya, termasuk TG, VLDL-C, IDL-C, LDL-C, HDL-C, apo-A, dan apo-B, hsCRP dilakukan pada Atherotech Diagnostik Lab (Birmingham, Alabama, Amerika Serikat), seperti yang dijelaskan sebelumnya [34]. Power dan ukuran sampel studi plasebo-terkontrol Sebelumnya acak telah menunjukkan bahwa pemberian EPA atau DHA terapi selama periode waktu 6 sampai 7 minggu dapat menyebabkan peningkatan kadar darah LC PUFA minimal 47% dan penurunan 3 n- tingkat TG darah 18-21% [35, 36]. Dengan asumsi tingkat OS darah dasar rata-rata minimal 3% dan perubahan
standar deviasi dari 1,5% dalam stratum studi tertentu [37], ukuran sampel dari 40 subyek per studi strata (yaitu 20 mata pelajaran ditugaskan untuk 6: 1-OM3 terapi, dan 20 mata pelajaran ditugaskan untuk plasebo) akan menghasilkan kekuatan minimal 90% untuk mendeteksi peningkatan kadar OS darah minimal 60% dalam mata pelajaran dalam 6: 1-OM3 studi lengan relatif terhadap mata pelajaran dalam kelompok plasebo, pada tingkat signifikansi alpha = 0,05 [37]. Dengan asumsi rata-rata dasar kadar TG minimal 1,58 mmol / L dan perubahan standar deviasi 0,40 mmol / L dalam studi strata tertentu,
ukuran sampel yang diusulkan dari 40 subyek per studi strata (subyek ie20 ditugaskan untuk 6: 1-OM3 terapi, dan 20 mata pelajaran ditugaskan untuk plasebo) akan menghasilkan kekuatan minimum 95% untuk mendeteksi penurunan relatif dalam tingkat TG darah minimal 30% dalam mata pelajaran dalam 6: 1-OM3 studi lengan relatif terhadap mata pelajaran dalam kelompok plasebo , pada tingkat signifikansi alpha = 0,05.
Analisa data Pada akhir penelitian, Clinical Pengadilan Komisi Peninjau menilai CRF kepatuhan dengan protokol dan mata pelajaran yang tertelan minimal 80% dari kapsul ditugaskan terkunci di. Data ditabulasi kemudian un-buta dan analisis dilakukan pada '' per protokol '' bagian dari studi. Perubahan median dan kisaran interkuartil dalam OS darah dan kadar OI selama periode 8 minggu, serta semua ukuran hasil sekunder dihitung untuk setiap mata pelajaran studi dan diselenggarakan oleh sub-populasi berdasarkan kelompok perlakuan, dan kohort. Perubahan persen dari awal sampai minggu 8 dihitung untuk setiap kelompok perlakuan (plasebo dan 6: 1-OM3) dan placeboadjusted perubahan median persen kemudian dihitung. Sebuah uji dua sisi t (berpasangan) dilakukan dengan menggunakan GraphPad Prism versi 6.0 untuk Macintosh (GraphPad Software) untuk menggambarkan perubahan plasebo-disesuaikan dan signifikansi didefinisikan sebagai aPvalueB0.05. Evaluasi keselamatan
Para peneliti utama yang memenuhi syarat di setiap situs dievaluasi pasien sementara kesehatan tetap blinded dengan resimen pengobatan studi. Semua efek samping, yang didefinisikan sebagai '' treatmentemergent '' (TEAE), yang terjadi selama masa studi, dievaluasi dan diklasifikasikan sebagai terkait atau tidak terkait dengan pengobatan oleh peneliti utama. Setiap TEAE tercatat dalam bentuk laporan kasus subjek individu pada setiap kunjungan klinik, melalui evaluasi pasien kesehatan, termasuk
kuesioner, pemeriksaan fisik, evaluasi uji laboratorium klinis, berat badan, dan BMI. Laporan disusun, dan dikategorikan berdasarkan kelas, tingkat keparahan, dan hubungan dengan mempelajari pengobatan. Clinical Pengadilan Komite Ulasan Ulasan formulir laporan kasus subyek ', dan setuju dengan tugas peneliti utama itu.
Hasil
deskripsi Studi dan karakteristik demografi dari subyek terdaftar Studi protokol garis ditunjukkan pada Gambar 1. Dari 655 disaring, 509 subyek tidak memenuhi syarat untuk pendaftaran studi sesuai kriteria inklusi / eksklusi di bagian metode. Sisanya 146 subyek dikelompokkan menjadi dua Kohort dan diacak, buta dan diperlakukan dengan
baik minyak jagung (A) atau 6: 1-OM3 (B). Tiga puluh enam mata pelajaran yang baik hilang untuk menindaklanjuti atau sesuai dengan perlakuan kurang dari 80%. Data OS dari 655
subyek disaring menunjukkan LC n-3 PUFA kekurangan gizi adalah umum di populasi umum di AS, dengan 89% dari subyek jatuh di bawah 6,1% OS (OS median 4,48%; kisaran 1,84-5,89%). Karakteristik dasar dari populasi penelitian yang terdaftar dan acak (Table1) dibandingkan dalam Kohort, dan seluruh kelompok perlakuan dengan jumlah kira-kira sama laki-laki dan perempuan yang terdaftar. Median dasar LC n-3 PUFA tingkat (diukur sebagai OS atau
OI) atau rata-rata kadar TG serum sebanding antara dua Kohort dan kelompok perlakuan. Mean BMI adalah [30 (obesitas) untuk semua kelompok dan Kohort. Penggunaan statin juga