2.3. Study Design
This was a randomized, double-blind, cross-over trial. The experiment was divided into two phases. Phase I was a study of RPG dietary fiber as an ingredient in pasta-based bakery products. Phase II was a study of RPG dietary fiber in the form of capsules and powders taken with meals. In each phase, all subjects received one of the test meals according to a random sequence automatically generated using a random number table. All subjects were required to eat all of the meals in each experiment phase. All 12 subjects participated in both phases of the experiment and took part in all the sample trials. The interval between the two phases of the experiment was 14 days, with a gap of 3 days between each sample experiment within each phase.The subjects were required to maintain the following dietary habits and lifestyle for 3 d before the start of the experimental day and during the washout period: a reasonable diet, regular meals, no overeating, no excessive dietary control, no alcohol consumption, regular work and rest, no late nights, no strenuous exercise on the day before the test, and no food or water after 10 p.m. on the night before the test. Subjects were followed up on and instructed regarding their diet during the study period using a dedicated recorder. All twelve subjects arrived at the Recovery Plus Clinic on the experimental day at 8:20 a.m. after 10–14 h of fasting using a convenient mode of transport. After resting for 10 min, all subjects consumed the designated control meal or the experimental meal at the stipulated time between 8:30 a.m. and 9:00 a.m.