2.2. Study Test Materials, Supplementation, and Dosages
The test dietary materials were a proprietary hesperetin-7-The study was a three-period crossover trial, wherein subjects of each group consumed the placebo and both a high dose (300 mg) and a low dose (150 mg) of the HEPT7G/βCD inclusion complex during three consecutive periods in a crossover manner, allowing a washout period of at least three days. Based on the safety test results concerning the HEPT7G/βCD inclusion complex [Hard hydroxypropyl methylcellulose (HPMC) capsules were prepared to contain a placebo and both high and low doses of the HEPT7G/βCD inclusion complex and were identical in appearance, size (17.2 mm), color (light brown), and packaging. Calcium stearate (CAS 1592-23-0; MW 607.02 g/mol) at a concentration of 1.0% was used as a lubricant with anti-adherent properties. The specifications of the active raw ingredient and placebo were confirmed by an independent laboratory of a capsule manufacturer (Japan Tablet Co., Ltd., Kyoto, Japan). The placebo capsule contained only β-CD, whereas, the high-dose active ingredient capsule contained 150 mg of HEPT7G/βCD inclusion complex [i.e., 19.50 mg of HEPT7G equivalent], and the low-dose active ingredient capsule contained 75 mg of HEPT7G/βCD inclusion complex [i.e., 9.75 mg of HEPT7G equivalent]. The weight of the capsules was adjusted based on the density and amount of β-CD.