(OR23-01-25) A Randomized, Triple-Blind, Placebo-Controlled Clinical Trial Investigating a Corn Leaf Extract (UP165) on Sleep Quality in Healthy Adults With Sleep Difficulties

Objectives: To investigate the safety and efficacy of a standardized corn leaf extract (UP165) on sleep quality in a healthy population with difficulty falling asleep and/or staying asleep.

Methods: This study consisted of a 28-day randomized, triple-blind, placebo-controlled, parallel clinical trial. Eighty healthy adults (n=40 per group) with difficulties falling and/or staying asleep were assigned to UP165 (500 mg orally administrated 60 minutes before bedtime) or placebo. Participants completed a 7-day run-in period prior to study visits at baseline (Day 0), Day 14 and Day 28 during which objective (actigraphy with electroencephalogram) and subjective (Pittsburgh Sleep Quality Index) sleep measures, blood serotonin, melatonin, and gamma-aminobutyric acid (GABA) levels were assessed. Safety was assessed at screening and Day 28.

Results: There were significant increases in total sleep time (35.2 ± 109.4 vs. -16.9 ± 74.1 min), rapid eye movement (REM; 8.3 ± 27.8 vs. -4.4 ± 22.0 min) and light sleep time (30.8 ± 91.4 vs. -12.4 ± 47.9 min) for the UP165 group compared to the Placebo group (all p< 0.05) at Day 28. Participants supplemented with UP165 had an increase in REM sleep (6.4 ± 17.4 vs. -3.2 ± 15.6 min; p=0.042) and decrease in awake duration (-17.9 ± 57.0 vs. 17.0 ± 64.1 min; p=0.021) compared to those on placebo at Day 14. Further, participants supplemented with UP165 had significantly fewer sleep interruptions and shorter sleep onset latency at Day 14 with shorter wake after sleep onset (WASO) and higher sleep efficiency at Days 14 and 28. Subjective sleep latency significantly improved from baseline at Days 14 and 28 for the UP165 group whereas the Placebo group improved at Day 28 only (p < 0.05). There were no significant differences in blood serotonin, melatonin, or GABA levels between UP165 and placebo. Supplementation with UP165 was found to be safe and well tolerated in the studied population.

Conclusions: The current study demonstrated supplementation with UP165 for 28 days significantly improved objective measures of sleep in a population of healthy adults with sleep difficulties.

Funding Sources: Funding by Unigen, Inc.