Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleep Supplement 1 | Active Comparator | Participants served Sleep Supplement 1 |
|
| Sleep Supplement 2 | Active Comparator | Participants served Sleep Supplement 2 |
|
| Sleep Supplement 3 | Active Comparator | Participants served Sleep Supplement 3 |
|
| Sleep Supplement 4 | Active Comparator | Participants served Sleep Supplement 4 |
|
| Placebo | Placebo Comparator | Participants served placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep Supplements | Dietary Supplement | Sleep supplements |
|
| Measure | Description | Time Frame |
|---|---|---|
| PROMIS Sleep Disturbance 8A | Perceived sleep quality | 0, 4, 8, and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| PROMIS Sleep Related Impairment 8A | Perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. | 0, 4, 8, and 12 weeks |
| Insomnia Severity Index (ISI) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Objectives | Occurrence of any Adverse Events (AEs/SAEs) | 0, 4, 8, and 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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.
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:
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlantia Clinical Trials Inc., 142 E. Ontario, Suite 1200 | Chicago | Illinois | 60611 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Randomised, Double-Blind, Placebo-Controlled, Parallel
Not provided
Not provided
Not provided
| Placebo | Other | Matching placebo |
|
Severity of sleep difficulties and satisfaction with sleep
| 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 | 0, 4, 8, and 12 weeks |
| Bristol Stool Scale (BSS) | Stool frequency and consistency | 0, 4, 8, and 12 weeks |
| D001523 |
| Mental Disorders |