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| Name | Class |
|---|---|
| British American Tobacco (Investments) Limited | INDUSTRY |
| HCD Research | INDUSTRY |
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A home placement, randomized, double blind, placebo-controlled, study to determine the effect of dietary liquid shot beverage products on self-reported measures of sleep, stress and mood on generally healthy participants with current self-reported mild/moderate sleep difficulties (but not clinical insomnia) and mild/moderate stress.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo comparator | Placebo Comparator | Investigational liquid shot beverage product: prototype 60ml product that does not contain study ingredients |
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| Experimental Product 1 | Experimental | Developmental liquid shot beverage product: prototype 60ml product that contains study ingredients |
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| Experimental Product 2 | Experimental | Developmental liquid shot beverage product: prototype 60ml product that contains study ingredients |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary supplement liquid shot beverage products | Dietary Supplement | Participants will use their product as instructed for 3 of the 4 study weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Sleep Disturbance | Change in Patient-Reported Outcomes Measurement Information Systems (PROMIS) - Sleep disturbance 8A Scores range from 8-40, where lower scores indicate lower sleep disturbance | Time points: Week 1, 2, 3 and 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Impairment | Change in Patient-Reported Outcomes Measurement Information Systems (PROMIS) - Sleep-related impairment score 8A Scores range from 8-40, where lower scores indicate lower sleep impairment | Time points: Weeks 1, 2, 3, and 4 |
| Insomnia Severity Scores range from 0-24, where lower scores indicate lower insomnia severity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Niedziela, PhD | HCD Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sago Atlanta - The Palisades Complex | Atlanta | Georgia | 30328 | United States |
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Parallel Assignment
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Change in Athens Insomnia Scale (AIS) score Scores range from 0-24, where lower scores indicate lower insomnia severity |
| Time points: Weeks 1, 2, 3, and 4 |
| Restorative Sleep Scores range from 0-100, where higher scores indicate better restorative sleep | Change in Restorative Sleep Questionnaire (RSQ) score Scores range from 0-100, where higher scores indicate better restorative sleep | Time points: Weeks 1, 2, 3, and 4 |
| Contentedness/Anxiety Scores range from 6-24, where lower scores indicate lower levels of state anxiety | Change in 6-item State Anxiety Inventory (STAI) - State Only portion Scores range from 6-24, where lower scores indicate lower state anxiety | Time points: Weeks 1, 2, 3, and 4 |
| Profile of Mood States (POMS 35 Item version) | Change in the following POMS scores:
Scores range from 0-20 for each score • Total Mood Disturbance Scores for total mood disturbance range from -20 to 100 | Time points: Weeks 1, 2, 3, and 4 |
| Daily Sleep diary | Change in the following:
| Time points: averages of weeks 1, 2, 3, and 4 (Sunday night - Thursday night consumption only, reported on Monday - Friday mornings) |