Safety evaluation of certain food additives - ipcs inchem

PHYTOSTEROLS, PHYTOSTANOLS AND THEIR ESTERS 141
Table 6. Observed effects on carotenoid, tocopherol and vitamin levels in human placebo-controlled, double-blinded studies
Food additive Study population Food item Daily intake a Study duration Observations Reference
Judd et al.
(2002)
42 days Decrease in absolute carotene
and carotene
plasma levels
2.2 g phytosterols/
day
Salad
dressings
53 moderately
hypercholesterolaemic
subjects
Phytosterol
esters
Ntanios et al.
(2002)
2 × 3 weeks Decrease in absolute carotene
plasma levels
compared with controls (no
lipid adjustment performed)
Fat spread 1.8 g phytosterols/
day
53 volunteers (normo- to
hypercholesterolaemic)
Phytosterol
esters
Raeini-Sarjaz
et al. (2002)
No effect on carotenoid
levels (increases noted
indicate changes in food
consumption behaviour)
2 × 3 weeks, crossover
Margarine 1.92 g sterol
esters/day, 1.76 g
stanol esters/day
15 hypercholesterolaemic
men
Phytosterol or
phytostanol
esters
Hendriks et al.
(2003)
1 year No effect on erythrocyte
deformability or clinical
chemistry parameters;
lower absolute and LDLadjusted
-carotene
concentrations, lower
absolute -carotene,
lycopene and -tocopherol
concentrations
185 healthy volunteers Fat spread 1.7 g phytosterols/
day
Phytosterol
esters
Homma et al.
(2003)
4 weeks No decrease in absolute
retinol or -carotene plasma
levels; slight decrease in tocopherol
level at 3 g/day
105 healthy volunteers Fat spread 2 or 3 g
phytostanols/day
Phytostanol
esters