Sleep Promoting Effects of IQP-AO-101: A Double-Blind, Randomized, Placebo-Controlled Exploratory Trial

Udo Bongartz, Bee-Kwan Tan, Stephanie Seibt, Gordana Bothe, Ralf Uebelhack, Pee-Win Chong, Natalia Wszelaki, Udo Bongartz, Bee-Kwan Tan, Stephanie Seibt, Gordana Bothe, Ralf Uebelhack, Pee-Win Chong, Natalia Wszelaki

Abstract

Objective: The purpose of this study was to explore the clinical benefit and tolerability of IQP-AO-101 in healthy subjects with sleep complaints.

Methods: This double-blind, randomized, placebo-controlled trial involved fifty subjects with sleep complaints. Subjects with a Pittsburgh Sleep Quality Index (PSQI) score between 6 and 15 were randomized to receive either IQP-AO-101 or placebo for 6 weeks, following a run-in period of one week. Sleep parameters were assessed at baseline and after 1, 4, and 6 weeks using the modified Athens Insomnia Scale (mAIS). Subjects were also instructed to wear an activity tracker and keep a sleep diary during the study. Other questionnaires administered were the Frankfurt Attention Inventory (FAIR-2) and the Profile of Mood States (POMS-65). Blood samples for safety laboratory parameters were taken before and at the end of the study.

Results: After 6 weeks, subjects who consumed IQP-AO-101 reported significant improvements in mAIS scores compared with placebo, including mAIS total score (11.76 ± 6.85 vs 4.00 ± 4.80; p < 0.001); night parameters composite score (5.20 ± 3.80 vs 2.04 ± 3.16; p = 0.001); and day parameters composite score (6.56 ± 4.10 vs 1.96 ± 2.65; p < 0.001). All individual parameters (Items 1 to 8) were also significantly improved from baseline after 6 weeks of IQP-AO-101 intake. Analysis of variance with baseline values as covariates showed statistically significant improvements across all individual parameters for IQP-AO-101 when compared to placebo. The measurements using the activity tracker, sleep diary, FAIR-2, and POMS did not reveal any significant differences between groups. No adverse effects related to the intake of IQP-AO-101 were reported. Tolerability was rated as very good by all the subjects and by the investigator for all cases.

Conclusions: In this study, IQP-AO-101 was well tolerated and efficacious for promoting sleep and enhancing daytime performance in subjects with moderate sleep disturbances.

Clinical trial registration: This trial is registered with ClinicalTrials.gov, no. NCT03114696.

Figures

Figure 1
Figure 1
Study schedule.
Figure 2
Figure 2
Mean mAIS total score (all parameters) during the 6-week IP intake. ∗p < 0.001 vs. placebo. Error bars denote standard error of mean.
Figure 3
Figure 3
Mean scores of individual mAIS parameters throughout the study. P values for comparison against placebo.
Figure 4
Figure 4
Frequency distribution, global assessment of benefit by investigator and subjects.

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