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This study is a randomized, double-blind, placebo-controlled study of N=140 adult men and women with sub-clinical sleep issues. This study to assess the effect of a novel dietary supplement on sleep related outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Maltodextrin + Flavoring |
|
| Novel Sleep Supplement | Experimental | Novel powdered sleep supplement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novel powdered sleep supplement | Dietary Supplement | A dietary sleep supplement consisting of vitamins, minerals, adaptogens, and whole food ingredients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tracked sleep activity | Assessed via Oura ring | 42 days |
| Sleep quality | Pittsburgh Sleep Quality Index and Restorative Sleep Questionnaire weekly | Baseline, week 3, and week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Dietary habits | Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool | Baseline and endpoint (week 6) |
| Oura Actigraphy - Daytime Activity | Daytime activity |
| Measure | Description | Time Frame |
|---|---|---|
| Comprehensive Metabolic Blood Panel | Serum concentrations of sodium, potassium, carbon dioxide, chloride, albumin, total protein, glucose, and calcium, ALT, AST, bilirubin, BUN, creatinine | Baseline and endpoint (week 6) |
| Complete blood count |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | Contact | (805) 292-0714 | ellen@citruslabs.com |
| Name | Affiliation | Role |
|---|---|---|
| Ellen O'Gorman | Citruslabs | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Citruslabs | Recruiting | Santa Monica | California | 90404 | United States |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| Placebo | Dietary Supplement | maltodextrin placebo |
|
| 42 days |
Circulating concentrations of white blood cells, red blood cells, hemoglobin, and hematocrit
| Baseline and endpoint (week 6) |
| D001523 |
| Mental Disorders |