Background: Different doses of phytosterols/-stanols up to a maximum of 4.0 g/day have been used in human safety studies, whereas only one small-scale study investigated some detailed clinical information about consumption levels exceeding 8.6 g/day.
Objective: To determine which population groups are likely to be at risk of excessive intakes if liberal enrichment of foods with phytosterols/-stanols will be allowed.
Design and subjects: Cross-sectional study among a representative sample (n=23 106) of the Dutch population, aged 20-60 y (MORGEN-project, 1993-1997). Phytosterol/-stanol intake was assessed with virtual replacement of one to four ordinary foods in the diet with enriched products. Percentile values were used to describe the distribution in simulated intake for different groups in the population, varying in sociodemographic and health characteristics. Multiple linear regression was used to describe the contribution of the different population characteristics to the simulated phytosterol/-stanol intake.
Results: If three commonly consumed products (margarine, cheese, yoghurt) were completely replaced, the median daily phytosterol/-stanol intake will be about 5.5 g in men and 4.6 g in women. In males, the intake above the 90th percentile will exceed 8.6 g/day. Women will approach this level. Especially, age, body mass index, socioeconomic status, subjective health, smoking behaviour, alcohol consumption, pregnancy (women) and high cholesterol level (men) contributed to the variance in the simulated intake (P<0.05), although the total explained variance was low (1-3%).
Conclusions: If liberal phytosterol/-stanol fortification is allowed, the daily intake might exceed the recommended intake level as well as our 'cutoff' level of 8.6 g/day. Postlaunch monitoring to identify consumers and real intake levels, refinement of scenario buiding, as well as human safety studies for levels above 8.6 g/day are necessary.