SleepNCT07669766
Somato® (Phytomelatonin) Versus Synthetic Melatonin and Placebo on Sleep Quality
A study testing Plant-based melatonin and Melatonin in people with Sleep, run by Nutraland USA, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Plant-based melatonin and Melatonin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 244 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2026to 17 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
N/A Decentralized Trial - address for CRO headquarters, not the study location
Wilmington, Delaware, 19808
About this study
Official title: 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant-based melatoninDietary supplement
Also called Somato®, Phytomelatonin
2mg Phytomelatonin (plant-based melatonin from tomatoes) capsule
MelatoninDietary supplement
Also called Synthetic melatonin
10mg Synthetic Melatonin capsule
PlaceboDietary supplement
Placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| Somato® | Experimental | Somato® Phytomelatonin 2mg Receives: Dietary Supplement: Plant-based melatonin |
| Synthetic Melatonin | Active comparator | Synthetic Melatonin - 10mg Receives: Dietary Supplement: Melatonin |
| Placebo | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Pittsburgh Sleep Quality Index (PSQI) Global Score at 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.
Measured: Baseline (Day 0) and Day 28
Secondary outcomes (8)
Change from Baseline Objective Sleep Efficiency at 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.
Measured: Baseline (Day 0) and Day 28
Change from Baseline Objective Total Sleep Time at Day 28
Total accumulated sleep duration in minutes per night, measured continuously via the Oura Ring 3.0 wearable device.
Measured: Baseline (Day 0) and Day 28
Change from Baseline Objective Sleep Latency at Day 28
The time taken to transition from full wakefulness to sleep in minutes, measured continuously via the Oura Ring 3.0 wearable device.
Measured: Baseline (Day 0) and Day 28
Change from Baseline Objective REM Sleep Duration at Day 28
Total duration of Rapid Eye Movement (REM) sleep in minutes per night, measured continuously via the Oura Ring 3.0 wearable device.
Measured: Baseline (Day 0) and Day 28
Change from Baseline Objective Deep Sleep Duration at Day 28
Total duration of Deep (slow-wave) sleep in minutes per night, measured continuously via the Oura Ring 3.0 wearable device.
Measured: Baseline (Day 0) and Day 28
Change from Baseline Objective Light Sleep Duration at Day 28
Total duration of Light sleep in minutes per night, measured continuously via the Oura Ring 3.0 wearable device.
Measured: Baseline (Day 0) and Day 28
Change from Baseline Nocturnal Resting Heart Rate at Day 28
Average overnight resting heart rate in beats per minute (bpm), measured continuously via the Oura Ring 3.0 wearable device.
Measured: Baseline (Day 0) and Day 28
Change from Baseline Nocturnal Heart Rate Variability (HRV) at 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.
Measured: Baseline (Day 0) and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start13 Jan 2026
- Primary completion17 Apr 2026
- Study completion17 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutraland USA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Reputable Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07669766
- Sponsor's protocol ID
- BB2512MD-154
- Status last verified
- Jun 2026
- First submitted
- 3 Feb 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Solutions in Focus: A Randomized Comparison of Phytomelatonin (Somato®), Synthetic Melatonin, and Placebo
- ClinicalTrials.gov ID
- NCT07669766
- Acronym / sponsor ID
- BB2512MD-154
- Conditions
- Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- Nutraland USA, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Reputable Health
- Study start
- 13 Jan 2026 (actual)
- Primary completion
- 17 Apr 2026 (actual)
- Study completion
- 17 Apr 2026 (actual)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Somato® | Experimental | Dietary Supplement: Plant-based melatoninSomato® Phytomelatonin 2mg |
| Synthetic Melatonin | Active comparator | Dietary Supplement: MelatoninSynthetic Melatonin - 10mg |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plant-based melatoninAlso: Somato®, Phytomelatonin2mg Phytomelatonin (plant-based melatonin from tomatoes) capsule | Dietary supplement | Somato® |
| MelatoninAlso: Synthetic melatonin10mg Synthetic Melatonin capsule | Dietary supplement | Synthetic Melatonin |
| PlaceboPlacebo capsule | Dietary supplement | Placebo |
Primary outcome
Change from Baseline Pittsburgh Sleep Quality Index (PSQI) Global Score at Day 28
Time frame: 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.
8 secondary outcomes
Change from Baseline Objective Sleep Efficiency at Day 28
Time frame: Baseline (Day 0) and Day 28
Change from Baseline Objective Total Sleep Time at Day 28
Time frame: Baseline (Day 0) and Day 28
Change from Baseline Objective Sleep Latency at Day 28
Time frame: Baseline (Day 0) and Day 28
Change from Baseline Objective REM Sleep Duration at Day 28
Time frame: Baseline (Day 0) and Day 28
Change from Baseline Objective Deep Sleep Duration at Day 28
Time frame: Baseline (Day 0) and Day 28
Change from Baseline Objective Light Sleep Duration at Day 28
Time frame: Baseline (Day 0) and Day 28
Change from Baseline Nocturnal Resting Heart Rate at Day 28
Time frame: Baseline (Day 0) and Day 28
Change from Baseline Nocturnal Heart Rate Variability (HRV) at Day 28
Time frame: Baseline (Day 0) and Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plant-based melatonin and Melatonin in people with Sleep, run by Nutraland USA, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Pittsburgh Sleep Quality Index (PSQI) Global Score at Day 28 (time frame: Baseline (Day 0) and Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.