Sleep
Conditions
Brief summary
This study examines the effects of a plant-based phytomelatonin supplement compared to synthetic melatonin and placebo in adults with suboptimal sleep quality. The research uses a randomized, double-blind, placebo-controlled, three-arm clinical trial design. The primary aim is to determine whether phytomelatonin improves sleep outcomes compared to placebo and whether it matches or exceeds synthetic melatonin. Participants will be randomly assigned to receive 2 mg phytomelatonin, 10 mg synthetic melatonin, or an inactive placebo. Each participant will take one capsule nightly for 28 days. Objective sleep metrics will be captured continuously using the Oura Ring wearable device. Subjective outcomes will be measured at baseline and post-intervention using validated surveys such as the Pittsburgh Sleep Quality Index and the SF-36. Weekly visual analog scales will assess morning grogginess. Safety, tolerability, and user experience differences between groups will also be evaluated.
Interventions
DIETARY_SUPPLEMENTPlant-based melatonin
2mg Phytomelatonin (plant-based melatonin from tomatoes) capsule
DIETARY_SUPPLEMENTMelatonin
10mg Synthetic Melatonin capsule
DIETARY_SUPPLEMENTPlacebo
Placebo capsule
Sponsors
Nutraland USA, Inc.
Reputable Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Device Compliance: Willingness to consistently wear an Oura Ring Gen3 and maintain an active membership throughout the study duration. * Baseline Sleep Score: A baseline Oura sleep score of less than 75, indicating sub-optimal sleep quality. * Oura Ring Usage History: Demonstrated at least 80% adherence to Oura Ring use during the 30 days prior to enrollment. * Health and Supplement Stability: No significant changes in dietary supplement use or medical history within the past 30 days, to ensure stability in baseline physiological and health conditions.
Exclusion criteria
* Current or recent use (within the past 30 days) of any sleep-promoting dietary supplement. * Current or recent use (within the past 30 days) of any sleep-promoting medications, whether prescription or over-the-counter. * Pregnant or breastfeeding women will be excluded from the study. * Substance Use Disorder: Individuals with a history of drug or alcohol dependency who have not maintained sobriety for a minimum of the past 12 months. * Severe Medical Conditions: Presence of severe or unstable medical conditions that may interfere with study participation or outcomes. * Use of Mood-Affecting Medications: Use of any medications known to significantly influence mood, circadian rhythms, or melatonin pathways. * Sensitivity to Nightshades: Known sensitivity or allergy to nightshade plants, including tomatoes, due to the nature of the study intervention.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline Pittsburgh Sleep Quality Index (PSQI) Global Score at Day 28 | Baseline (Day 0) and Day 28 | The PSQI is a self-administered questionnaire used to measure sleep quality and disturbances over a 1-month time interval. The questionnaire consists of 19 individual items, creating 7 component scores that are summed to yield one global score. The total score ranges from 0 to 21, where lower scores denote better sleep quality. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline Objective Sleep Efficiency at Day 28 | Baseline (Day 0) and Day 28 | Sleep efficiency percentage as measured continuously via the Oura Ring 3.0 wearable device. Calculated as the percentage of time in bed spent asleep. |
| Change from Baseline Objective Total Sleep Time at Day 28 | Baseline (Day 0) and Day 28 | Total accumulated sleep duration in minutes per night, measured continuously via the Oura Ring 3.0 wearable device. |
| Change from Baseline Objective Sleep Latency at Day 28 | Baseline (Day 0) and Day 28 | The time taken to transition from full wakefulness to sleep in minutes, measured continuously via the Oura Ring 3.0 wearable device. |
| Change from Baseline Objective REM Sleep Duration at Day 28 | Baseline (Day 0) and Day 28 | Total duration of Rapid Eye Movement (REM) sleep in minutes per night, measured continuously via the Oura Ring 3.0 wearable device. |
| Change from Baseline Objective Deep Sleep Duration at Day 28 | Baseline (Day 0) and Day 28 | Total duration of Deep (slow-wave) sleep in minutes per night, measured continuously via the Oura Ring 3.0 wearable device. |
| Change from Baseline Objective Light Sleep Duration at Day 28 | Baseline (Day 0) and Day 28 | Total duration of Light sleep in minutes per night, measured continuously via the Oura Ring 3.0 wearable device. |
| Change from Baseline Nocturnal Resting Heart Rate at Day 28 | Baseline (Day 0) and Day 28 | Average overnight resting heart rate in beats per minute (bpm), measured continuously via the Oura Ring 3.0 wearable device. |
| Change from Baseline Nocturnal Heart Rate Variability (HRV) at Day 28 | Baseline (Day 0) and Day 28 | Overnight Heart Rate Variability (HRV) in milliseconds (ms) using the rMSSD (Root Mean Square of Successive Differences) method, measured continuously via the Oura Ring 3.0 wearable device. |
Countries
United States
Outcome results
None listed