A Study Design Of Pp1420 Embedded The Energy Intake

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Abstract The imbalance between the energy intake and the energy expenditure can overtime lead to obesity, a major global health problem. PP1420 was designed to mimic human natural gut hormone (PP) controlling appetite. The study design of PP1420 embedded the energy intake study in human in laboratory setting is a unique opportunity in order to investigate energy intake studies, and understand how to measure and analyse food intake data in Phase I clinical studies. In this thesis, the student explored the energy intake, fluid intake, and visual analogue scale (VAS) of subjects in the first (8mg of PP1420) and the second (16mg) cohort of the study. The analysis showed no statistically significant change of each meal between visits for all subjects and of individual subject in both cohorts. The Coefficient of Variation (CV) of Energy Intake (EI) of each meal type per visit of the cohort showed low-variance in every meal type of each visit in both cohorts. Although there was also no statistically significant change of total (24-hr) fluid intake across three dosing visits of both cohorts, there were insignificant negative relationships between the fluid intake and the energy intake of all dosing visits in the 1st cohort and of the dosing visit 3 in the 2nd cohort. For VAS score, there is no significant VAS change from baseline among three dosing visits in both cohorts in response to questions about Hunger, Sickness, Satisfaction of Appetite, Fullness, and Prospective Food
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