Safety evaluation of certain food additives - ipcs inchem

PHYTOSTEROLS, PHYTOSTANOLS AND THEIR ESTERS 147
of coronary atherosclerosis, which can be detected by electron beam computer
tomography. No association was found for either end-point for -sitosterol and
campesterol levels, but plasma cholesterol levels were significantly associated with
both CHD family history and coronary artery calcium (Wilund et al., 2004).
In a prospective nested case–control study (1993–2003, European Prospective
Investigation of Cancer [EPIC] Norfolk population study, including 25 633
men and women between 45 and 79 years of age) of 373 cases of coronary
artery disease and 758 controls, -sitosterol and campesterol plasma concentrations
were investigated. Blood samples were taken at the beginning of the
prospective study. Phytosterol concentrations were similar in both groups and were
not associated with coronary disease. The -sitosterol/cholesterol ratio was
significantly lower in cases than in controls; the campesterol/cholesterol ratio did
not differ between groups (Pinedo et al., 2007).
A group of 1242 individuals aged >65 years who participated in the crosssectional
Longitudinal Aging Study Amsterdam (LASA) was investigated for an
association between CHD and phytosterol plasma concentrations. Concentrations
of -sitosterol, campesterol, stigmasterol and brassicasterol, as well as their ratios
to cholesterol, were significantly lower in cases than in controls. Based on logistic
regression analysis, a reduced risk for CHD was associated with higher -sitosterol
levels (Fassbender et al., 2008).
Similarly, results from another case–control study with women with incident
CHD and age-matched population-based controls did not show an association
between phytosterol plasma concentrations and CHD risk. Phytosterol plasma
levels of 186 female CDH patients were compared with those of 231 healthy
controls. Phytosterol levels of patients were higher than those of controls and did
not show a correlation to CHD risk. After adjustment to cholesterol, the odds ratio
was 0.89 (95% CI = 0.611.30) (Windler et al., 2009).
2.5.4 Other effects
In a population-based study, possible health effects after long-term (1-year)
consumption of food enriched with phytosterol esters were investigated in 185
volunteers. No adverse health effects were reported that could be linked to
phytosterol supplementation. Levels in erythrocyte membranes paralleled the
increase in plasma concentrations. No changes in erythrocyte membrane rigidity or
deformability were observed. No consistent effects on clinical chemistry or
haematological parameters were observed. Hormone levels in female and male
participants were unaffected by phytosterol consumption (Hendriks et al., 2003).
Female sex hormone levels were investigated in a human trial including
24 healthy volunteers (12 males and 12 females). Study participants daily
consumed 40 g of a margarine enriched with phytosterol esters (8.6 g phytosterols/
day) or a standard margarine. Serum sex hormone levels (estradiol, estrone,
progesterone, human luteinizing hormone, follicular stimulating hormone and sex
hormone binding globulin) in females were unaffected by phytosterol ester
consumption compared with controls, with the exception of progesterone, which
was significantly lower in the test group. Faecal composition and faecal bacterial