ABSTRAK
Uji klinis acak tersamar ganda paralel ini merupakan penelitian pendahuluan,bertujuan mengetahui pengaruh suplementasi serat larut dan diet rendah kaloriseimbang (DRKS) selama 4 minggu terhadap kadar kolesterol low-densitylipoprotein (LDL) serum pada obes I usia 30−50 tahun. Sejumlah 31 subyekdipilih dengan kriteria tertentu dan dibagi menjadi dua kelompok denganrandomisasi blok, 15 orang kelompok perlakuan (KP) dan 16 orang kelompokkontrol (KK). Subyek KP mendapat serat larut psyllium husk (PH) 8,4 g/hari danDRKS 1200 kkal/hari, sedangkan subyek KK mendapat plasebo dan DRKS 1200kkal/hari. Data terdiri atas usia, indeks massa tubuh (IMT), asupan zat gizi, sertakadar kolesterol LDL serum. Pemeriksaan kolesterol LDL dilakukan pada awaldan akhir penelitian. Analisis data menggunakan uji t tidak berpasangan danMann-Whitney, batas kemaknaan 5%. Karakteristik data dasar dan sebaransubyek kedua kelompok sebanding. Analisis lengkap dilakukan pada 28 subyek(KP dan KK masing-masing 14 subyek). Suplementasi ditoleransi baik dan tidakditemukan efek samping serius. Median usia subyek KP dan KK berturut-turut35,0 (30−45) tahun dan 34,50 (30−48) tahun serta rerata IMT 28,0 ± 1,1 kg/m2dan 27,2 ± 1,4 kg/m2. Rerata kadar kolesterol LDL serum awal KP 137,0 ± 37,0mg/dL dan KK 134,4 ± 29,1 mg/dL. Defisit energi KP lebih rendah tidaksignifikan (p = 0,62) dibandingkan KK, berturut-turut -282,0 ± 482,6 kkal/haridan -331,8 ± 578,3 kkal/hari. Persentase asupan energi terhadap anjuran KP (94,2± 18,5%) lebih tinggi signifikan (p = 0,02) daripada KK (85,4 ± 22,9%). Asupankarbohidrat (KH) total KP (613,1 ± 134,5 kkal/hari) lebih tinggi signifikan (p =0,02) dibandingkan KK (545,4 ± 161,1 kkal/hari). Asupan protein, lemak total,dan kolesterol KP dan KK sesuai rekomendasi NCEP-ATP III. Pada keduakelompok, asupan asam lemak jenuh cenderung tinggi, tetapi asupan asam lemaktak jenuh tunggal dan jamak rendah. Asupan serat subyek KP 17,2 ± 2,8 g/haridan KK 8,6 (5,2−15,2) g/hari. Dengan suplementasi PH tidak tercapairekomendasi asupan serat. Persentase asupan KH sederhana terhadap energi totalKP 11,5±5,4% lebih tinggi signifikan (p = 0,00) dibandingkan KK 6,0(1,2524,2)%. Penurunan kadar kolesterol LDL serum KP -2,1 ± 16,2 mg/dLlebih sedikit tidak signifikan (p = 0,15) dibandingkan pada KK -10,9 ± 15,3mg/dL. Penelitian ini belum dapat membuktikan suplementasi PH 8,4 g/hari danDRKS 1200 kkal/hari selama 4 minggu lebih baik dalam menurunkan kadarkolesterol LDL serum dibandingkan plasebo pada subyek obes I.
ABSTRACT
This parallel double blind randomized clinical trial is a preliminary study thataims to investigate the effect of soluble fiber supplementation 8.4 g/day and lowcaloriebalanced diet (LCBD) for 4 weeks on serum low-density lipoprotein(LDL) cholesterol level in obese I, aged 30−50 years old. A total of 31 subjectswere selected using certain criteria and randomly allocated to one of two groupsusing block randomization; 15 subjects for treatment (T) group and 16 subjects forcontrol (C) group, respectively. The T group received psyllium husk (PH) 8.4g/day and LCBD 1200 kcal/day, and the C group received placebo and LCBD1200 kcal/day. Data include age, body mass index (BMI), intake of energy,macronutrient, and fiber, as well as serum LDL cholesterol level. Serum LDLcholesterol level was examined before and after treatment. Statistical analysesinclude independent t-test and Mann-Whitney with significance level of 5%.Subjects characteristics of the two groups at baseline was not statisticallydifferent. Twenty eight subjects (14 subjects in each group) completed theintervention. Supplementation was well tolerated and there were no seriousadverse events. The mean age in T and C group was 35.0 (30.0−45.0) and 34.5(30.0−48.0) years, respectively, and BMI was 28.0 ± 1.1 and 27.2 ± 1.4 kg/m2,respectively. The pretreatment serum LDL cholesterol level in T and C group was137.0 ± 37.0 and 134.4 ± 29.1 mg/dL, respectively. Energy deficit in T group wasinsignificantly lower (p = 0.62) than in C group; -282.0 ± 482.6 and -331.8 ±578.3 kcal/day, respectively. Percentage of energy intake to recommendation in Tgroup (94.2 ± 18.5%) was significantly higher (p = 0.02) than that in C group(85.4 ± 22.9%). Total carbohydrate (CHO) intake in T group (613.1 ± 134.5kcal/day) was significantly higher (p = 0.02) than in C group (545.4 ± 161.1kcal/day). Total protein, fat, and cholesterol intake were similar to the NCEP-ATPIII recommendation in both groups. Intake of SAFA was higher thanrecommended, meanwhile PUFA and MUFA intake were lower than thoserecommended in both groups. Dietary fiber intake in T and C group was 17.2 ±2.8 and 8.6 (5.2−15.2) g/day, respectively. During the intervention, PHsupplementation did not meet the recommendation. Percentage of simple CHO tototal energy in T group 11.5±5.4% was significantly higher (p = 0.00) than in Cgroup 6.0 (1.2524.2)%. PH supplementation decreased serum LDL cholesterollevel (-2.1 ± 16.2 mg/dL) lower than placebo (-10.9 ± 15.3 mg/dL), but notsignificant different (p = 0.15). This study shows that PH supplementation 8.4g/day in combination with LCBD 1200 kcal/day for 4 weeks in obese I aged30−50 years old is not proven to decrease the serum LDL cholesterol level. |
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