Somato® (Phytomelatonin) Versus Synthetic Melatonin and Placebo on Sleep Quality
25. juni 2026 oppdatert av: Nutraland USA, Inc.
Sleep Solutions in Focus: A Randomized Comparison of Phytomelatonin (Somato®), Synthetic Melatonin, and Placebo
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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
244
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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Delaware
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Wilmington, Delaware, Forente stater, 19808
- N/A Decentralized Trial - address for CRO headquarters, not the study location
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Placebo komparator: Placebo
|
Placebo kapsel
|
|
Aktiv komparator: Synthetic Melatonin
Synthetic Melatonin - 10mg
|
10mg Synthetic Melatonin capsule
Andre navn:
|
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Eksperimentell: Somato®
Somato® Phytomelatonin 2mg
|
2mg Phytomelatonin (plant-based melatonin from tomatoes) capsule
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from Baseline Pittsburgh Sleep Quality Index (PSQI) Global Score at Day 28
Tidsramme: 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.
|
Baseline (Day 0) and Day 28
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from Baseline Objective Sleep Efficiency at Day 28
Tidsramme: 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.
|
Baseline (Day 0) and Day 28
|
|
Change from Baseline Objective Total Sleep Time at Day 28
Tidsramme: Baseline (Day 0) and Day 28
|
Total accumulated sleep duration in minutes per night, measured continuously via the Oura Ring 3.0 wearable device.
|
Baseline (Day 0) and Day 28
|
|
Change from Baseline Objective Sleep Latency at Day 28
Tidsramme: 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.
|
Baseline (Day 0) and Day 28
|
|
Change from Baseline Objective REM Sleep Duration at Day 28
Tidsramme: 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.
|
Baseline (Day 0) and Day 28
|
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Change from Baseline Objective Deep Sleep Duration at Day 28
Tidsramme: 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.
|
Baseline (Day 0) and Day 28
|
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Change from Baseline Objective Light Sleep Duration at Day 28
Tidsramme: 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.
|
Baseline (Day 0) and Day 28
|
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Change from Baseline Nocturnal Resting Heart Rate at Day 28
Tidsramme: 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.
|
Baseline (Day 0) and Day 28
|
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Change from Baseline Nocturnal Heart Rate Variability (HRV) at Day 28
Tidsramme: 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.
|
Baseline (Day 0) and Day 28
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from Baseline 36-Item Short-Form Health Survey (SF-36) Score at Day 28
Tidsramme: Baseline (Day 0) and Day 28
|
The SF-36 is a multi-purpose, short-form health survey.
Scored from 0 to 100, where higher scores mean better health outcomes.
|
Baseline (Day 0) and Day 28
|
|
Change from Baseline Morning Functioning Visual Analogue Scale (VAS) Composite Score at Day 28
Tidsramme: Baseline (Day 0) and Day 28
|
Morning functioning assessed via a 6-item questionnaire utilizing a Visual Analogue Scale.
Items measure dimensions such as grogginess, sleepiness, difficulty concentrating, alertness, feeling refreshed, and readiness for the day.
Individual items are directionally aligned and averaged to create a composite score ranging from 1 to 10, where higher scores represent better morning functioning.
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Baseline (Day 0) and Day 28
|
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Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Sub-component Scores at Day 28
Tidsramme: Baseline (Day 0) to Day 28
|
The Pittsburgh Sleep Quality Index (PSQI) is a 19-item self-reported questionnaire that evaluates subjective sleep quality changes from baseline.
Each component is scored on a Likert scale ranging from 0 to 3, where higher scores reflect a greater severity of sleep difficulties within that specific domain.
|
Baseline (Day 0) to Day 28
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Samarbeidspartnere og etterforskere
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Sponsor
Samarbeidspartnere
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
13. januar 2026
Primær fullføring (Faktiske)
17. april 2026
Studiet fullført (Faktiske)
17. april 2026
Datoer for studieregistrering
Først innsendt
3. februar 2026
Først innsendt som oppfylte QC-kriteriene
22. juni 2026
Først lagt ut (Faktiske)
25. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
30. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
25. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- BB2512MD-154
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