OBJECTIVE:The current study aimed to evaluate the effect of fortified milk combined with a lifestyle and counselling programme on several CVD risk factors after a 3-month dietary intervention. DESIGN:Hypercholesterolaemic adults were randomized to a group supplemented with low-fat milk that was enriched with phytosterols, α-linolenic and linoleic fatty acids, vitamins and antioxidants (enriched milk group, EMG: n 40), a placebo milk group (PMG: n 36) or a control group (CG: n 25). The EMG and PMG consumed respectively 500 ml of enriched milk or placebo milk daily and attended biweekly counselling sessions over a 3-month period. SETTING:Harokopio University, Athens, Greece. SUBJECTS:A sample of 101 hypercholesterolemic adults aged 40-60 years. RESULTS:Regarding lifestyle changes, total and saturated fat intakes decreased significantly in both intervention groups compared with the CG (P < 0·005). Furthermore, total steps were increased (P = 0·029) and BMI was decreased (P = 0·017) significantly in both intervention groups compared with the CG. Regarding biochemical indices, EPA content in erythrocyte membranes increased (P < 0·001) while serum C-reactive protein decreased (P = 0·003) significantly in both intervention groups compared with the CG. Finally, significant increases in plasma folic acid and vitamin B12 levels and a significant decrease in homocysteine levels were observed in the EMG compared with the PMG and CG (all P < 0·001). A favourable change in LDL cholesterol:HDL cholesterol was also observed in the EMG and tended to be significant compared with the PMG and CG (P = 0·066). CONCLUSIONS:The present study showed that consumption of fortified milk accompanied with lifestyle counselling induces extra benefits in terms of LDL cholesterol:HDL cholesterol and serum homocysteine levels.