SleepPhase 1NCT06935123
Impact of Nutritional Supplementation on Sleep Quality
A Phase 1 study testing Sleep Supplements in people with Sleep and Sleep Quality, run by Pharmavite LLC at 1 site in United States.
Trial summary
This is a randomized, double-blind, placebo-controlled, 5-arm parallel-group study to evaluate the effects of 4 nutritional supplements on sleep over a 12 week period in healthy U.S. adults. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Sleep Quality
- What is being tested?
- Sleep Supplements
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 376 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2025to 31 Oct 2025
- Phase
- Phase 1
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be able to give written informed consent.
- Be between 18-65 years of age (inclusive).
- Insomnia severity Index score ≤14.
- PROMIS Sleep Disturbance Questionnaire raw score ≥23
- Be willing to maintain stable dietary habits and physical activity levels throughout the study period.
- Willing to consume the study product daily for the duration of the study.
Who cannot join
- Participants who are pregnant or wish to become pregnant during the study or who are lactating and/or currently breastfeeding.
- Participants currently of biological childbearing potential, but not using a continuous effective method of contraception as determined by the investigator.
- Has a history of drug and/or alcohol abuse.
- Hypersensitive to the contents of the study product.
- Participants with work schedules that result in irregular sleep patterns/ or have night-shift employment.
- High caffeine intake, >400mg/day.
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- Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history. Excluded health conditions include:
- Diagnosed Sleep disorders
- Major psychiatric diagnosis (e.g., bipolar), as diagnosed by a healthcare professional, including major depressive disorder (e.g., clinical depression)
- Immunocompromised health conditions
- Currently or recently (in the past 4 weeks) taking a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results. Prohibited medications include:
- Prescribed sleep medications
- Prescribed Medications which impact sleep, including but not limited to sedative hypnotics, anxiolytics, and antidepressants.
- Current or recent (in the past 4 weeks) use of prohibited nutritional and non-nutritional supplements with known or possible sleep effects (e.g. valerian, multivitamins, melatonin)
- Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the study.
- Participants may not be participating in other clinical studies. If the participant has previously taken part in an experimental study, the Investigator must ensure sufficient time has elapsed before entry to this study to ensure the integrity of the results.
Trial locations and contacts
1 site in 1 country.
United States1 site
Atlantia Clinical Trials Inc., 142 E. Ontario, Suite 1200
Chicago, Illinois, 60611
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Parallel-Group Study Evaluating Nutritional Supplementation On Sleep Quality
This is a randomized, double-blind, placebo-controlled, 5-arm parallel-group study to evaluate the effects of 4 nutritional supplements on sleep over a 12 week period in healthy U.S. adults.
- Conditions
- Sleep, Sleep Quality
- Being tested
- Sleep Supplements, Placebo
- Keywords
- sleep, sleep quality, magnesium
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep SupplementsDietary supplement
Sleep supplements
PlaceboOther
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Sleep Supplement 1 | Active comparator | Participants served Sleep Supplement 1 Receives: Dietary Supplement: Sleep Supplements |
| Sleep Supplement 2 | Active comparator | Participants served Sleep Supplement 2 Receives: Dietary Supplement: Sleep Supplements |
| Sleep Supplement 3 | Active comparator | Participants served Sleep Supplement 3 Receives: Dietary Supplement: Sleep Supplements |
| Sleep Supplement 4 | Active comparator | Participants served Sleep Supplement 4 Receives: Dietary Supplement: Sleep Supplements |
| Placebo | Placebo comparator | Participants served placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
PROMIS Sleep Disturbance 8A
Perceived sleep quality
Measured: 0, 4, 8, and 12 weeks
Secondary outcomes (4)
PROMIS Sleep Related Impairment 8A
Perceived functional impairments during wakefulness associated with sleep problems or impaired alertness.
Measured: 0, 4, 8, and 12 weeks
Insomnia Severity Index (ISI)
Severity of sleep difficulties and satisfaction with sleep
Measured: 0, 4, 8, and 12 weeks
Depression, Anxiety, and Stress Scale - 21 Items (DASS-21)
Severity of general psychological distress and symptoms related to depression, anxiety, and stress
Measured: 0, 4, 8, and 12 weeks
Bristol Stool Scale (BSS)
Stool frequency and consistency
Measured: 0, 4, 8, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start15 May 2025
- Primary completion26 Sep 2025
- Study completion31 Oct 2025
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, Double-Blind, Placebo-Controlled, Parallel
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 376 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmavite LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06935123
- Sponsor's protocol ID
- AFCRO-189
- Status last verified
- Feb 2026
- First submitted
- 11 Apr 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Parallel-Group Study Evaluating Nutritional Supplementation On Sleep Quality
- ClinicalTrials.gov ID
- NCT06935123
- Acronym / sponsor ID
- AFCRO-189
- Conditions
- Sleep, Sleep Quality
- Keywords
- sleep, sleep quality, magnesium
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 376 participants (actual)
- Lead sponsor
- Pharmavite LLCIndustry (pharma, biotech, devices)
- Study start
- 15 May 2025 (actual)
- Primary completion
- 26 Sep 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 20 Apr 2025 (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 is a randomized, double-blind, placebo-controlled, 5-arm parallel-group study to evaluate the effects of 4 nutritional supplements on sleep over a 12 week period in healthy U.S. adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
- Model description
- Randomised, Double-Blind, Placebo-Controlled, Parallel
| Arm | Type | Receives |
|---|---|---|
| Sleep Supplement 1 | Active comparator | Dietary Supplement: Sleep SupplementsParticipants served Sleep Supplement 1 |
| Sleep Supplement 2 | Active comparator | Dietary Supplement: Sleep SupplementsParticipants served Sleep Supplement 2 |
| Sleep Supplement 3 | Active comparator | Dietary Supplement: Sleep SupplementsParticipants served Sleep Supplement 3 |
| Sleep Supplement 4 | Active comparator | Dietary Supplement: Sleep SupplementsParticipants served Sleep Supplement 4 |
| Placebo | Placebo comparator | Other: PlaceboParticipants served placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be able to give written informed consent.
- Be between 18-65 years of age (inclusive).
- Insomnia severity Index score ≤14.
- PROMIS Sleep Disturbance Questionnaire raw score ≥23
- Be willing to maintain stable dietary habits and physical activity levels throughout the study period.
Key exclusion criteria (16 listed)
- Participants who are pregnant or wish to become pregnant during the study or who are lactating and/or currently breastfeeding.
- Participants currently of biological childbearing potential, but not using a continuous effective method of contraception as determined by the investigator.
- Has a history of drug and/or alcohol abuse.
- Hypersensitive to the contents of the study product.
- Participants with work schedules that result in irregular sleep patterns/ or have night-shift employment.
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 |
|---|---|---|
| Sleep SupplementsSleep supplements | Dietary supplement | Sleep Supplement 1, Sleep Supplement 2, Sleep Supplement 3, Sleep Supplement 4 |
| PlaceboMatching placebo | Other | Placebo |
Primary outcome
PROMIS Sleep Disturbance 8A
Time frame: 0, 4, 8, and 12 weeks
Perceived sleep quality
4 secondary outcomes
PROMIS Sleep Related Impairment 8A
Time frame: 0, 4, 8, and 12 weeks
Insomnia Severity Index (ISI)
Time frame: 0, 4, 8, and 12 weeks
Depression, Anxiety, and Stress Scale - 21 Items (DASS-21)
Time frame: 0, 4, 8, and 12 weeks
Bristol Stool Scale (BSS)
Time frame: 0, 4, 8, and 12 weeks
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 27 Feb 2026.
- Individual participant dataSharing planned: No
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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 Phase 1 study testing Sleep Supplements in people with Sleep and Sleep Quality, run by Pharmavite LLC 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 6 inclusion and 16 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 27 Feb 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
PROMIS Sleep Disturbance 8A (time frame: 0, 4, 8, and 12 weeks). 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 27 Feb 2026.