4.3. Study Design
120 mg/dL ≤ LDL
This study was a double-blinded, randomized, and placebo-controlled trial with a 12-week treatment period. After an initial screening, 72 subjects (Male 36, Female 36) with 120 mg/dL ≤ LDL <160 mg/dL were selected as shown in After allocating the participants into two groups, they were directed to take two tablets per day containing policosanol 10 mg (RaydelAll participants received advice to avoid excess food (<1800 and 1500 kcal for men and women, respectively, per day), cholesterol (<600 mg per day), and alcohol drinking (<30 and <15 g of ethanol for men and women, respectively, per day), and no smoking both direct and indirect, which can interfere with the lipoprotein metabolism. They were also instructed to avoid intense exercise (<30 min daily at 60–80% maximum capacity). After 12 weeks of consumption, the blood parameters of all participants who completed the program were analyzed. Then, the lipid and lipoprotein parameters were analyzed after excluding those who violated dietary and exercise guidelines, such as omitting daily consumption, overeating, a significantly more fat diet, smoking, and heavy drinking, and failed the other exclusion criteria after stratified analysis based on the self-reported questionnaire.