2.7. Study Design and Procedures
high-density lipoprotein
ADVERSE EVENTS, BLOOD, ADVERSE EVENT
The study was conducted at Pharma Foods International Co., Ltd. (Kyoto, Japan). It was a randomized, double-blind, placebo-controlled, crossover trial. In this crossover trial, the participants were randomly allocated to the experimental food–placebo sequence or the placebo–experimental food sequence based on the random numbers (generated in Excel) assigned to each of them. The random allocation was performed by an independent third party not involved in the study, and the allocation sequence was concealed before and until assignment to prevent selection bias. The allocation was blinded to the participants, investigators, caregivers and outcome assessors. The two interventions of each sequence were separated by a washout period of one week. On the day prior to each intervention, each participant was given an identical meal as dinner and asked to refrain from consuming any food or beverage except water from 21:00 until 9:00 the following morning. On the day of intervention, which started shortly after 9:00, the participants were instructed to self-administer the experimental food or placebo with drinking water and then to consume the standardized high-fat meal within 15 min. Blood samples were collected before intake of the experimental food/placebo (0 h) and at 2 h, 3 h, 4 h, and 6 h after consumption of the high-fat meal. Throughout the study, the participants were instructed to maintain their habitual diet and physical activity patterns. The participants were also required not to start to use any functional foods or nutritional supplements (i.e., expect those routinely used) other than the experimental food/placebo during the study. On the day prior to each intervention, the participants were asked to refrain from alcohol intake and strenuous physical activity. Moreover, from the day prior to the first intervention until completion of the second intervention, any use of medicines or functional foods or nutritional supplements was documented on a daily basis. Adverse events were monitored via participant interview by the physician at the time of blood specimen collection and self-reports during the study.The primary endpoints of this study were the differences in postprandial serum TG levels at sequential sampling time points and the incremental area under the curve (iAUC) of postprandial serum TGs between the two intervention arms. Secondary outcome measures include the differences in postprandial serum remnant-like lipoprotein particle (RLP) cholesterol levels at sequential sampling time points and the RLP cholesterol iAUC between the intervention arms, and the differences in other lipid metabolism-related parameters, including FFAs, total cholesterol, phospholipids, beta lipoproteins (βLPs), high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, and blood glucose. The safety endpoint of this trial was the occurrence of adverse events.