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1 Effects of a Mixing Tea Drink Containing Depolymerized. Sodium Alginate on Serum Total Cholesterol and Assessment of its Safety ABSTRACT A double blind placebo-controlled study was conducted in 100 subjects whose serum total cholesterol level was 200^S/aI- or higheq and LDl-cholesterol was I2\mS/dL or higher to clarify the effect of a mixing tea drink containing depolymefized sodium alginate on the serum total cholesterol. The subjects were randomly divided into two groups. For 12 weeks, subjects in the test group were given I bottle of the test drink and subjects in the placebo group were given the placebo drink. It is noteworthy that total cholesterol in the test group decreased at 12 weeks compared to the baseline (0 week). The level of LDl-cholesterol decreased significantly at 4, 8 and 12 weeks compared to the baseline (p<0.05). Total cholesterol and LDl-cholesterol levels were also found to be significantly lower at 4, 8 and L2 weeks than those in placebo group when shown as percentages to the initial levels (1,<0.05). And the administration of the test drink for L2 weeks did not show any adverse effects. Furthermore,2! subjects whose serum total cholesterol level was 200 mg/dl or highe4 and LDl-cholesterol was I20 ms/dl or higher were given 3 bottles of the test drink a day for 4 weeks and the safety of its excessive intake was evaluated. No adverse effect was observed in physiological, hematological and biochemical parameters by this experiment. These results suggested that the tested mixing tea drink containing depolymertzed sodium alginate improved hypercholesterolemia on subjects with total cholesterol2-2}} mg/ dl, and LDl-cholesterol>Lz} mg/dl without any adverse effects. Opn Pharmacol Ther 2OO7 ; 35 : L133-47) KEY WORDS Depolymeized sodium alginate, Mixing tea drink, Total cholesterol
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3 Screening Wash out Double blind. placebo controlled study Postobservation period Control group group Fig. 1 Protocol of double blind, placebo controlled study of the mixing tea drink containing depolymerized sodium alginate Thble 1 Composition of placebo drink and test drink Energy (kcal) Water (g) Protein Lipid (g) Dietary fiber (S) Carbohydrate (g) Sodium (g) esh (g) Depolymerized sodium alginate (S) by Medical*Online Presented
4 Sex Age Height Body weight BMI Systolic blood pressure Diastolic blood pressure Pulse Total cholesterol LDL-cholesterol HDL-cholesterol Tiiglyceride
5 Group are expressed as meantsd. Data *p<o.os vs. placebo group, #p{0.05 vs. baseline (O w), ##p{0.0l vs. baseline. Thble 4 Effects of test drink on serum total cholesterol and LDl-cholesterol in all subjects Group Data are expressed as mean-fsd. *p<o.os vs. placebo group, **p(0.01 vs. placebo group, #p<o.os vs. baseline (ow),##p10.01vs. baseline, $p(0.05 (twoway ANOVA).
6 Group expressed as meantsd. Dataare #p<o.os vs. baseline (0w), ##p10.01vs. baseline. 0.5t0.2# 0.5t t LL6.2# # 5L2.9!L28.4 Table 6 Effects of test drink on serum total cholesterol and LDl-cholesterol in all subjects (total cholesterol >22O nlg/dl) Group Data are expressed as meantsd. *p<o.os vs. placebo group, #p10.05 vs. baseline (O w), ##p<0.0i vs. baseline. 1138
7 hrameter Group Data are expressed as meantsd. *p(0.05 vs. placebo soup, * * : p<0.01 vs. placebo group, #P<O.os vs. baseline (O w).
8
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10 Screening Wash out Open study Appendix 1 Protocol of excessive intake safty study of the mixing tea drink containing depolymerized sodium alginate. Appendix 2 Baseline characteristics of the study subjects for Study II Unit All subjects (n:zl) Unit Data are expressed as meantsd. n:2i Appendix 4 Daily activity of study subjects (Stuay I ) Group n Data are e:<pressed as meantsd.
11 krameter Data are expressed as meantsd. n:21 Appendix 6 Changes in subject characteristics (Study I ) Unit Group n Data are expressed as mean-fsd. * *p(0.01 vs. placebo Soup, #p<o.os vs. baseline (O w), ##p10.0i vs. baseline.
12 Standard value ?00/ ul 5795tt t r265x 5947! t t 1190 M xL04/uL F xto4/ul!! r"" t46.4## r## 460.9L # M s/dl F rr.2-r5.2 s/dl 14.6+r.4# L1.5# 14.2iL L+t M L.9o/o F /o t t4.2# i4.r M fL F fl 94.7l_5.0## r # t5.6## ## 94.8t5.4# 94.6t4.0## M pg F pg i L2.0# ## ##! "" ## M 31.8-s6.4% F % 32.4L r tt tr.r xt04/ ul ! ## 25.6t t5.r## # "" s/dl 7.3f # t L0.4 7.LL s/dl "" 4.5t t0.2## ** # ms/ai- 0.7t # 0.7r # r0-40u/l t r L U/L r t i t t U/L r87.5t ,5+30.6## t82j+20.5## # U/L 2L r97.7 i5r.8# # t50.3# 2t4.6i g+54.5## 22r ## M <7eU/L F =48U/L M U/L F rJ/L 37.2L t21.9 I24.9t t r r r t # t t t mg/dl t2.5"" 13.8i3.4 t3.5t2.8# 13.6t t+3.2 1z.o ms/ar are expressed as meantsd. Data t it t *p{0.05 vs. placebo group, * *p(0.01 vs. placebo group. #p vs. baseline (0 w), ##p10.0t vs. baseline.
13 Appendix 7 (continued) Standard value Creatinine M mg/dl F ms/dl meq,/f meq/l meq/l ms/tr ^g/dr ms/ar M 60-2L0us/dL F us/dL ms/al o/o 0.7t0.1# !0.f" 140.9t 1.8 r4l.2+t.3 4.r+0.3"" ** t ** "" 2.2t0.1## 2.3+0J*## # L I t0.3#!! 4.9!0.4"" t03# 9.4t0.3"" t0.2# ## 140.9i 1.6 r40.6tl.7# "" ** L## 2.3!.0.t** # ## t0.3# Data are expressed as meantsd. *p(0.05vs.placebogroup,**p(0.01vs.placebogroup,#p(0.05vs.baseline (ow),##p{o.}ivs.baseline ## 0.7t0.2** i # L04.2tt.g## ** * *,## 3.7t L # 9r "" Appendix 8 Changes in subject characteristics (Study II) Body weight BMI Body fat ratio Systolic blood pressure Diastolic blood pressure Pulse Data are expressed as meantsd. n:21 #p<o.os vs. baseline (o w), oob<0.0i vs. baseline 59.8t 11.9# 22.L+3.L# t i t f 11.9# 22.It i ltI.o 69.7! ## r# t07.7+t
![Standard value 150-219 ^s/dr 3500-9700/ ul M 438-577xL04/ ul F 376-516 xto+/ ui M 13.6-18.3 s/at F 7I.2-15.2 s/dl M 40.4-5]-.9o/o F 34.3-45.20/o M 83-101fL F 80-101fL M 28.2-34.7 pe F 26.4-34.](/docs-images/88/114729001/images/14-1.jpg "3 pg M 31.8-36.4%o F 31.3-36.1% I+.0-37.9xL04/ ul 6.5-8.2 e/dl 3.7-5.5 s/dl 70-40u/L 5-45U/L 120-245U/L 0.2-1.0 mg/at 104-338 U/L M S79U/L F <48U/L M 50-230 U/L F 50-2r0u/L 8-20 ng/dl M 0.65-1.")
14 Standard value ^s/dr / ul M xL04/ ul F xto+/ ui M s/at F 7I s/dl M ]-.9o/o F /o M fL F fL M pe F pg M %o F % I xL04/ ul e/dl s/dl 70-40u/L 5-45U/L U/L mg/at U/L M S79U/L F <48U/L M U/L F 50-2r0u/L 8-20 ng/dl M ^e/at F mg/at <7.0 mg/dl meq/l meq/l meq/t ms/ar mg/at r ms/dl M us/dL F us/dL ms/at o/o M 2I-282 ng/ml F ne/ml mg/af M ms/ai- F ms/dl ^g/tt <7.5mg/dL me/ar L347"" t73# 14.rtl ## 225.Li33.2!4 30.1t 1.6## 32.6l0.9## r t t t 10.4 r68.3tl t0.5## t2.7t3.r f 5.0t tL -## 4.2t0.4** 101.9t t t0.4"" t t i L t7.0 r02.4i t t i t ## 29.9it t0.9## ! t0.2 2t t72.7tr t ,8f 15.6 L72.2t '," tL t 1.3## # 9.6i t0.6"" O.f " 93.3i t # I L i tL L.4t i i t t4.0## f i t i # I82.5i tL t f f r3g.7tl.2## 4.2t0.4# ## i "" ,9t ## t20.r Data are expressed as meantsd, n:21 #p(0.05 vs. baseline (o w), ##p10.01vs. baseline.
15 Appendix 9 (continued) hrameter Standard value NEEA meq/l 0.5t A t lipoprotein f mg/dl L28.9 M3.9t1S2.8 4E4.BtL34.t utt.t+lz4.t ApoA- I M mg/,at L54.Eir6.T r86.2+2l.l 1b9.0t22.0 1ss.bt16.5 F mg/dl Apo A- II M "7 mg/at 30.2ts.3 3L.oil.z sr.tl4.s 30.9rb.1 F mg/at Apo B M mg/,ar 98.6t20.9 gg.btz t20.6 gz.gtzz.t F mg/dl Apo C- II M mg/at 3.6+t.b 4.0+Ls# s.gtr. # 4.0+Lz## F ms/al- Apo C-IIII M mg/at 9.2+L F mg/dl Apo E M mg/dl t0.7# F mg/dL ApoB/A- I Tt0.z 0.zl,0.z 0.6t0.2 vitamin A 27.2-t02.7 ug/dl #o lr5.f# Vitamin E O.?5-I.41mg,/dL I.Z+0.2## I
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