[Minimal effective dose on serum cholesterol concentration and the safety evaluation of dressing containing plant sterol in Japanese subjects].
We examined the minimal effective dose on serum cholesterol concentration and the safety of dressing containing plant sterol in humans. EXP.1: Sixty-eight healthy Japanese males (total cholesterol (TC) > or = 170 mg/dL) were randomly divided into four groups, and were given 0, 400, 800 or 1200 mg/day of plant sterol in 15 g dressing for 4 weeks followed by the washout period of 4 weeks. Although there were no significant differences in serum TC and low-density lipoprotein cholesterol (LDL-C) concentrations among all groups after feeding plant sterol for 4 weeks, in 36 subjects with TC > or = 220 mg/dL, serum LDL-C concentration tended to reduce when received 800 or 1200 mg of plant sterol, and the difference between 0 and 1200 mg groups was statistically significant. The difference between 0 and 800 mg groups was near significant (p=0.053). Intake of 400 mg of plant sterol did not change serum LDL-C concentration. EXP.2: Twenty-one healthy Japanese subjects (TC > or = 180 mg/dL, 10 men, 11 women) were given 2400 mg/day of plant sterol in 45 g dressing for 4 weeks. Clinical data were all remained normal. These results indicated that minimal effective dose of the plant sterol on serum cholesterol concentration in healthy male subjects is around 800 mg/day, and intake of 2400 mg/day of plant sterol is regarded to be safe.
Kurokawa
Masanori
M
R&D Division, Q.P. Corporation, Tokyo, Japan. masanori_kurokawa@kewpie.co.jp
Masuda
Yasunobu
Y
Noda
Mitsuhiro
M
Marushima
Ranko
R
Usuda
Mika
M
Takeda
Sayaka
S
Hasegawa
Mineo
M
Homma
Yasuhiko
Y
Sugano
Michihiro
M
D000328:Adult; D044466:Asian People; D008078:Cholesterol, LDL / Q000097:blood*; D005260:Female; D005503:Food Additives / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D010840:Phytosterols / Q000008:administration & dosage* / Q000009:adverse effects; D013997:Time Factors
D008078:Cholesterol, LDL; D005503:Food Additives; D010840:Phytosterols