Somato® (Phytomelatonin) Versus Synthetic Melatonin and Placebo on Sleep Quality
25 de junio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
244
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
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Delaware
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Wilmington, Delaware, Estados Unidos, 19808
- N/A Decentralized Trial - address for CRO headquarters, not the study location
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador de placebos: Placebo
|
Cápsula de placebo
|
|
Comparador activo: Synthetic Melatonin
Synthetic Melatonin - 10mg
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10mg Synthetic Melatonin capsule
Otros nombres:
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Experimental: Somato®
Somato® Phytomelatonin 2mg
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2mg Phytomelatonin (plant-based melatonin from tomatoes) capsule
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from Baseline Pittsburgh Sleep Quality Index (PSQI) Global Score at Day 28
Periodo de tiempo: 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.
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Baseline (Day 0) and Day 28
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from Baseline Objective Sleep Efficiency at Day 28
Periodo de tiempo: 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.
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Baseline (Day 0) and Day 28
|
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Change from Baseline Objective Total Sleep Time at Day 28
Periodo de tiempo: 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
Periodo de tiempo: 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
|
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Change from Baseline Objective REM Sleep Duration at Day 28
Periodo de tiempo: 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
Periodo de tiempo: 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.
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Baseline (Day 0) and Day 28
|
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Change from Baseline Objective Light Sleep Duration at Day 28
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from Baseline 36-Item Short-Form Health Survey (SF-36) Score at Day 28
Periodo de tiempo: 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
Periodo de tiempo: 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
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Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Sub-component Scores at Day 28
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
13 de enero de 2026
Finalización primaria (Actual)
17 de abril de 2026
Finalización del estudio (Actual)
17 de abril de 2026
Fechas de registro del estudio
Enviado por primera vez
3 de febrero de 2026
Primero enviado que cumplió con los criterios de control de calidad
22 de junio de 2026
Publicado por primera vez (Actual)
25 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
30 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
25 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- BB2512MD-154
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .