Clinical study design
This study enrolled 45 healthy volunteers (24 female and 21 male subjects) to participate in a 6-week sleep and overall well-being trial. Subjects were randomized to receive UP165 (Supplement) or a nonactive corn starch placebo (Placebo). Subjects (age range 19–73 years) were instructed to consume the supplement or placebo ∼60 minutes before bedtime daily for 4 weeks after a 2-week baseline period (no supplementation). The active test material, UP165, was administered orally at 250 and 500 mg/day. Following a 2-week baseline monitoring period, groups were assigned. Sleep Quality (latency, efficiency, and deep/rapid eye movement [REM] time) was monitored nightly, and POMS and Pittsburgh Sleep Quality Survey were monitored weekly for each subject in each group for a period of 4 weeks. Salivary cortisol level was also determined for all subjects on Day 0 and weekly for 4 weeks.