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| Name | Class |
|---|---|
| Momentous | UNKNOWN |
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The purpose of this clinical trial is to assess the effects of a supplement combination on measures of sleep quality and stress in healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AM active, PM active | Experimental |
| |
| AM active, PM placebo | Active Comparator |
| |
| AM placebo, PM active | Active Comparator |
| |
| AM placebo, PM placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| All Active Supplement Combinations (Ashwagandha, Rhodiola rosea, magnesium threonate, L-theanine, and apigenin)) | Combination Product | Ashwagandha, Rhodiola rosea, magnesium threonate, L-theanine, and apigenin. |
| Measure | Description | Time Frame |
|---|---|---|
| Cohen's Perceived Stress scale | To determine changes in perceived stress by way of the Cohen's Perceived Stress scale. The minimum is 0 and max is 40, with higher values meaning more stress. | Baseline, Day 7, Day 14, Day 21, Day 28 |
| Positive mood and emotion | Assessed by the Positive and Negative Affect Scale. Min values of 0 and max of 50, higher scores indicate more positive moods and emotions. | Baseline, Day 7, Day 14, Day 21, Day 28 |
| Negative mood and emotion | Assessed by the Positive and Negative Affect Schedule. Min values of 0 and max of 50, higher scores indicate more negative moods and emotions. | Baseline, Day 7, Day 14, Day 21, Day 28 |
| Weekly sleep disturbances. | Assessed by the Patient Reported Outcome Measures of sleep disturbances. Min values of 8 and max values of 40. Higher scores mean more sleep disturbances. | Baseline, Day 7, Day 14, Day 21, Day 28 |
| Weekly sleep impairment | Assessed by the Patient Reported Outcome Measures of sleep impairments. Min values of 8 and max values of 40. Higher scores mean more sleep impairments. | Baseline, Day 7, Day 14, Day 21, Day 28 |
| Changes in daily psychological stress | Assessed by the Daily Stress Response Scale. Min 0, max 60 with higher scores indicating higher stress. | Daily for 4-weeks from baseline to Day 28. |
| Changes in daily physiological stress |
| Measure | Description | Time Frame |
|---|---|---|
| Percent compliance of supplement use | To determine the percent of compliance when taking AM and PM pills. Will be measured by the amount of pills taken / pills prescribed multiplied by 100. | End of Week 2 and Week 3. |
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Inclusion Criteria:
If participant began taking a supplement within the past month, participant will be asked to discontinue supplement use followed by a 2-week washout prior to participation.In all other cases, supplement use will be asked to be maintained throughout the study.
• The participant has an apple device with iOS 16 or greater software.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Carolina Sport Science Lab | Columbia | South Carolina | 29208 | United States |
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Randomized, placebo-controlled, between subjects, double-blind.
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| AM Active Supplement Combination (Ashwagandha and Rhodiola rosea) | Combination Product | Ashwagandha and Rhodiola rosea |
|
| PM Active Supplement Combination (Magnesium threonate, L-theanine, and apigenin) | Combination Product | Magnesium threonate, L-theanine, and apigenin. |
|
| AM and PM Placebo | Other | Placebo AM and PM |
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Assessed by Daily Stress Response Scale. Min 0, max 60 with higher scores indicating higher stress. |
| Daily for 4-weeks from baseline to Day 28. |
| Changes in subjective sleep quality. | Assessed by the Pittsburgh Sleep Quality Index questionnaire. Min 0 and max 21, higher scores indicate worse sleep quality. | Baseline and Day 28. |
| Changes in objective sleep quality. | Assessed by the Absolute Rest device, higher scores are better. | Daily for 4-weeks from baseline to Day 28. |
| Changes in sleep efficiency. | Assessed by the Absolute Rest device, total time asleep divided by time in bed, expressed as a percentage, higher is better. | Daily for 4-weeks from baseline to Day 28. |
| Changes in sleep latency | Assessed by the Absolute Rest device, time taken to fall asleep. | Daily for 4-weeks from baseline to Day 28. |
| Changes in sleep duration | Assessed by the Absolute Rest device, total sleep time. | Daily for 4-weeks from baseline to Day 28. |
| Changes in sleep apnea | Assessed by the Absolute Rest device, values measures by oxygen saturation. | Daily for 4-weeks from baseline to Day 28. |
| ID | Term |
|---|---|
| C030693 | Ashwagandha |
| C011369 | threonic acid |
| C026166 | theanine |
| D047310 | Apigenin |
| ID | Term |
|---|---|
| D047309 | Flavones |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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