2.2. Treatment
After a 2-week period of diet standardization, enrolled volunteers were randomized to receive either a daily 15 mL stick of a ready-to-drink formulation containing 2.5 g of phytosterols and 0.33 mg of thiamin in demineralized water and sodium carboxymethylcellulose as thickener (1 stick), or an indistinguishable placebo (The study products were manufactured and packaged in accordance with Quality Management System ISO 9001:2008 and the European Good Manufacturing Practices (GMP), satisfying requirements in “Code Of Federal Regulation” title 21, volume 2, part 111.Randomization was performed centrally using computer-generated codes. Participants and investigators were blinded to the group assignment. Randomization codes were kept in a sealed envelope that was opened after study completion and data analysis.For each treatment sequence, each patient was provided with boxes containing 30 sticks and was instructed to take a stick once daily, just before the main meal. At the end of each treatment sequence, all unused sticks were retrieved for inventory. Participants’ compliance was assessed by counting the number of returned sticks and calculating the ratio between the number of days from the first day of treatment and the number of sticks consumed by the participants.