Trial · NCT05808595
Registered outcomes32
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 32
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The difference in change in stress as assessed by salivary cortisol from baseline at Days 14 and 28 between AlphaWave® L-Theanine and Placebo. | Day 0, day 14, day 28 | |
| Secondary | The difference in change in stress as measured by the Perceived Stress Scale (PSS) from baseline at Days 14 and 28 between AlphaWave® L-Theanine and Placebo. | Day 0, day 14, day 28 | |
| Secondary | The difference in change in the stress subscale as measured by the Depression Anxiety and Stress Scale (DASS)-21 from baseline at Days 14 and 28 between AlphaWave® L-Theanine and Placebo. | Day 0, day 14, day 28 | |
| Secondary | The difference in change in the depression subscale as measured by the Depression Anxiety and Stress Scale (DASS)-21 from baseline at Days 14 and 28 between AlphaWave® L-Theanine and Placebo. | Day 0, day 14, day 28 | |
| Secondary | The difference in change in the anxiety subscale as measured by the Depression Anxiety and Stress Scale (DASS)-21 from baseline at Days 14 and 28 between AlphaWave® L-Theanine and Placebo. | Day 0, day 14, day 28 | |
| Secondary | The difference in change in the total score measured by the Depression Anxiety and Stress Scale (DASS)-21 from baseline at Days 14 and 28 between AlphaWave® L-Theanine and Placebo. | Day 0, day 14, day 28 | |
| Secondary | The difference in change in sleep between AlphaWave® L-Theanine and Placebo from baseline at Days 14 and 28, as assessed by the Healthy People Sleep Quality Index (HPSQI). | Days 0, 14, and 28 | |
| Secondary | The difference in change in sleep between AlphaWave® L-Theanine and Placebo from baseline at Days 14 and 28, as assessed by actigraphy readings. | Days 0, 14, and 28 | Actigraphy readings will include data on sleep duration, sleep onset, wake time, sleep latency, sleep efficiency, sleep stages, arousal count, and sleep score (0-100). |
| Secondary | The difference in change in cognition between AlphaWave® L-Theanine and Placebo from baseline at Days 14 and 28. | Days 0, 14, and 28 | The difference in change in cognition will be assessed by the Computerized Mental Performance Assessment System (COMPASS): Stroop Test, Simple Reaction Time, and Choice Reaction Time. |
| Secondary | The difference in change in mood between AlphaWave® L-Theanine and Placebo from baseline at Days 14 and 28. | Days 0, 14, and 28 | The difference in change in mood will be assessed by the Profile of Mood States (POMS) questionnaire. |
| Secondary | Incidence of pre-emergent and post-emergent adverse events (AE) following supplementation with AlphaWave® L-Theanine and Placebo. | 28 days | |
| Secondary | Measurement of blood pressure (BP) following supplementation with AlphaWave® L-Theanine and Placebo. | screening, day 0, day 14, day 28 | |
| Secondary | Measurement of heart rate (HR) following supplementation with AlphaWave® L-Theanine and Placebo. | screening, day 0, day 14, day 28 | |
| Secondary | Measurement of aspartate aminotransferase (AST) following supplementation with AlphaWave® L-Theanine and Placebo. | screening, day 28 | |
| Secondary | Measurement of alanine aminotransferase (ALT) following supplementation with AlphaWave® L-Theanine and Placebo. | screening, day 28 | |
| Secondary | Measurement of alkaline phosphatase (ALP) following supplementation with AlphaWave® L-Theanine and Placebo. | screening, day 28 | |
| Secondary | Measurement of total bilirubin following supplementation with AlphaWave® L-Theanine and Placebo. | screening, day 28 | |
| Secondary | Measurement of creatinine following supplementation with AlphaWave® L-Theanine and Placebo. | screening, day 28 | |
| Secondary | Measurement of electrolytes following supplementation with AlphaWave® L-Theanine and Placebo. | screening, day 28 | Electrolytes to be measured include sodium, potassium, and chloride. |
| Secondary | Measurement of glucose following supplementation with AlphaWave® L-Theanine and Placebo. | screening, day 28 |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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