The goal of this clinical trial is to evaluate the effect of the Botanical Extract in improving sleep symptoms of nonrestorative sleep (NRS) in healthy adults. The main question it aims to answer is • Does the Botanical Extract improve sleep quality and reduce symptoms of nonrestorative sleep (NRS)? Researchers will compare the Botanical Extract to a placebo to see if it works. Participants will: * Take one of 3 doses of the Botanical Extract (125 mg/day, 250mg/day ,500mg/day) or a placebo every day for 8 weeks. * Visit the clinic four times for checkups and tests and receive three follow-up phone calls.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
160
Two capsules per day (125 mg/day) before sleep, with or without food, for 8 weeks.
Two capsules per day (250 mg/day) before sleep, with or without food, for 8 weeks.
Two capsules per day (500 mg/day) before sleep, with or without food, for 8 weeks
Two capsules per day before sleep, with or without food, for 8 weeks.
Atlantia Food Clinical Trials Ltd.
Cork, Ireland
RECRUITINGSleep restorative quality
To evaluate the impact of 8 weeks daily supplementation of the Botanical Extract on Non-Restorative Sleep (NRS) as assessed by Restorative Sleep Questionnaire (RSQ-W) score compared to placebo. The total score range from 0-100 with higher scores indicating better restorative sleep.
Time frame: 8 weeks
Sleep Quality
To evaluate the impact of 8 weeks daily supplementation with the Botanical Extract compared to placebo on Sleep quality as assessed by Pittsburgh Sleep Quality Questionnaire (PSQI). The total score range from 0 to 21 with the higher score indicating worse sleep quality.
Time frame: 8 weeks
Attention-Rapid Visual Information Processing (RVIP)
To evaluate the impact of 8 weeks of daily supplementation with the Botanical Extract compared to a placebo on attention using the Millisecond Rapid Visual Information Processing (RVIP) task. The following metrics will be collected and evaluated: latency (speed of response) probability of false alarms, and sensitivity
Time frame: 8 weeks
Attention-Sustained Attention to Response Task (SART).
To evaluate the impact of 8 weeks of daily supplementation with the Botanical Extract compared to a placebo on attention as assessed by the Millisecond Sustained Attention to Response Task (SART). The following metrics will be collected and evaluated: errors of commission, errors of omission, and reaction time.
Time frame: 8 weeks
Cognition
To evaluate the impact of 8 weeks daily supplementation with the Botanical Extract compared to placebo on cognition as assessed by Cognitive Function: PROMIS - Abilities-Short Form 8a. The form consists of 8 items, each rated on a 5-point scale from "Never" to "Very often" with higher scores indicating better cognitive function
Time frame: 8 weeks
Stress
To evaluate the impact of 8 weeks daily supplementation with the Botanical Extract compared to placebo on stress as assessed by serum cortisol levels (μg/dL).
Time frame: 8 weeks
Sleep parameters-Total Sleep Time (TST)
To assess the effect of 8 weeks of daily Botanical Extract supplementation versus placebo on TST(minutes), based on Actigraphy-measured average weekly differences and total change from baseline (Day 0) to Day 56.
Time frame: 24-hour wear time for 8 weeks
Sleep Parameters- Wake After Sleep Onset (WASO)
To assess the effect of 8 weeks of daily Botanical Extract supplementation versus placebo on WASO (minutes), based on Actigraphy-measured average weekly differences and total change from baseline (Day 0) to Day 56.
Time frame: 24-hour wear time for 8 weeks
Sleep Parameters- Sleep Onset Latency (SOL)
To assess the effect of 8 weeks of daily Botanical Extract supplementation versus placebo on SOL (minutes), based on Actigraphy-measured average weekly differences and total change from baseline (Day 0) to Day 56.
Time frame: 24-hour wear time for 8 weeks.
Sleep Parameters- Sleep Efficiency (SE)
To assess the effect of 8 weeks of daily Botanical Extract supplementation versus placebo on SE (%), based on Actigraphy-measured average weekly differences and total change from baseline (Day 0) to Day 56. 24-hour wear time for 8 weeks
Time frame: 24-hour wear time for 8 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.