Somato® (Phytomelatonin) Versus Synthetic Melatonin and Placebo on Sleep Quality
25 juni 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
244
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
Delaware
-
Wilmington, Delaware, Verenigde Staten, 19808
- N/A Decentralized Trial - address for CRO headquarters, not the study location
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-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Ja
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Placebo-vergelijker: Placebo
|
Placebo-capsule
|
|
Actieve vergelijker: Synthetic Melatonin
Synthetic Melatonin - 10mg
|
10mg Synthetic Melatonin capsule
Andere namen:
|
|
Experimenteel: Somato®
Somato® Phytomelatonin 2mg
|
2mg Phytomelatonin (plant-based melatonin from tomatoes) capsule
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change from Baseline Pittsburgh Sleep Quality Index (PSQI) Global Score at Day 28
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change from Baseline Objective Sleep Efficiency at Day 28
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
|
Change from Baseline Objective Deep Sleep Duration at Day 28
Tijdsspanne: 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
|
|
Change from Baseline Objective Light Sleep Duration at Day 28
Tijdsspanne: 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
|
|
Change from Baseline Nocturnal Resting Heart Rate at Day 28
Tijdsspanne: 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
|
|
Change from Baseline Nocturnal Heart Rate Variability (HRV) at Day 28
Tijdsspanne: 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
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change from Baseline 36-Item Short-Form Health Survey (SF-36) Score at Day 28
Tijdsspanne: 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
Tijdsspanne: 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.
|
Baseline (Day 0) and Day 28
|
|
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Sub-component Scores at Day 28
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
13 januari 2026
Primaire voltooiing (Werkelijk)
17 april 2026
Studie voltooiing (Werkelijk)
17 april 2026
Studieregistratiedata
Eerst ingediend
3 februari 2026
Eerst ingediend dat voldeed aan de QC-criteria
22 juni 2026
Eerst geplaatst (Werkelijk)
25 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
30 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
25 juni 2026
Laatst geverifieerd
1 juni 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- BB2512MD-154
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
ONBESLIST
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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