Minimal Effective Dose on Serum Cholesterol Concentration and the Safety Evaluation of Dressing Containing Plant Sterol in Japanese Subjects

Abstract

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) 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 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 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.

A dose-response and meta-analysis of phytosterols consumption on liver enzymes

“…For example, studies by Hendriks et al (1999) and Jakulj et al (2005) were not included in our analyses due to the lack of baseline values of liver enzymes. However, the results in these two studies were in line with our results, and did not find any significant relationship between Phytosterol supplementation and liver enzymes (Hendriks et al , 1999; Seki et al , 2003; Richter et al , 1996; Kurokawa et al , 2008; Jakulj et al , 2005; Derosa et al , 2018; Christiansen et al , 2001; Hsu et al , 2017; Gylling et al , 2010). Conversely other studies have reported contradictory results to that reported in our study.…”

“…Eighteen studies reported the effect of Phytosterol supplementation on liver function. Among the included studies one study, used two doses of Phytosterol (Hironaka et al , 2006) and two used three doses (Kurokawa et al , 2008; Davidson et al , 2001)and we considered as separate studies. These studies were published between 1996 and 2018.…”

“…Twelve of studies were from the Asian populations (Hironaka et al , 2006; Hsu et al , 2017; Javanmardi et al , 2018b; Kriengsinyos et al , 2015; Ishizaki et al , 2003; Matsuoka et al , 2004; Seki et al , 2003; Kurokawa et al , 2008; Takeshita et al , 2007), three from American populations (Davidson et al , 2001), and three from European populations (Gylling et al , 2010; Richter et al , 1996). The duration of intervention ranged from 4 to 52 weeks.…”

“…The duration of intervention ranged from 4 to 52 weeks. Four studies were conducted on males (Seki et al , 2003; Kurokawa et al , 2008) and two on females (Hsu et al , 2017; Takeshita et al , 2007). All studies were trial and two had a crossover design (Kurokawa et al , 2008; Takeshita et al , 2007).…”

“…Four studies were conducted on males (Seki et al , 2003; Kurokawa et al , 2008) and two on females (Hsu et al , 2017; Takeshita et al , 2007). All studies were trial and two had a crossover design (Kurokawa et al , 2008; Takeshita et al , 2007). The dose of Phytosterol supplementation differed from 12 to 9000 milligrams/day.…”