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This study is a double-blind, randomized, three-arm, single-dose, placebo-controlled crossover trial of forty (40) apparently healthy male and female participants. The objective of this study is to assess the effects of AmaTea Max Organic Guayusa Extract and Lion's Mane on cognitive responses including mental clarity, mood, focus, concentration, productivity, anxiety/stress, happiness, and accuracy.
This study is a double-blind, randomized, three-arm, single-dose, placebo-controlled crossover trial of forty (40) apparently healthy male and female participants. The objective of this study is to assess the effects of AmaTea Max Organic Guayusa Extract and Lion's Mane on cognitive responses including mental clarity, mood, focus, concentration, productivity, anxiety/stress, happiness, and accuracy. Since these dietary supplements are on the market for consumer use, it is important to investigate and confirm their potential benefits, comparisons, and safety through further research.
Subjects will attend 4 study visits. During Visit 1, subjects will be screened for participation (i.e., medical history, routine blood work, background baseline diet). During Visits 2, 3 and 4, at 3 time points (pre-ingestion, 60 and 120 minutes post ingestion), participants will complete subjective baseline testing including questionnaires that assess mental clarity, mood, focus, concentration, productivity, anxiety/stress, and the Happiness Scale in addition to completing a series of objective neuropsychological tests (e.g., Go/no-go test, N-back test, Serial Sevens test) to assess cognitive performance. Safety will be monitored via vital signs (heart rate, blood pressure) and adverse events (AE) throughout study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 650 mg of placebo, given as two capsules containing maltodextrin |
|
| AmaTea Max Guayusa extract | Experimental | 650 mg of AmaTea Guayusa Extract, given as two capsules |
|
| Lion's Mane | Experimental | 1000 mg of Lion's Mane, given as two capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | 650 mg of placebo, given as two capsules containing maltodextrin |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration | Concentration as measured by a traditional 10 cm visual analogue scale (VAS), where values can range from 0 to 10, and higher values represent better concentration. | Change from baseline to 60 minutes and 120 minutes. |
| Mental Clarity | Mental clarity as measured by a traditional 10 cm visual analogue scale (VAS), where values can range from 0 to 10, and higher values represent better mental clarity. | Change from baseline to 60 minutes and 120 minutes. |
| Mood | Mood as measured by a traditional 10 cm visual analogue scale (VAS), where values can range from 0 to 10, and higher values represent better mood. | Change from baseline to 60 minutes and 120 minutes. |
| Focus | Focus as measured by a traditional 10 cm visual analogue scale (VAS), where values can range from 0 to 10, and higher values represent better focus. | Change from baseline to 60 minutes and 120 minutes. |
| Productivity | Productivity as measured by a traditional 10 cm visual analogue scale (VAS), where values can range from 0 to 10, and higher values represent better productivity. | Change from baseline to 60 minutes and 120 minutes. |
| Stress | Stress as measured by a traditional 10 cm visual analogue scale (VAS), where values can range from 0 to 10, and higher values represent greater stress. | Change from baseline to 60 minutes and 120 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic blood pressure | Systolic blood pressure in mm of mercury. | Change from baseline to 60 minutes and 120 minutes. |
| Diastolic blood pressure | Diastolic blood pressure in mm of mercury. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tim Ziegenfuss, PhD | The Center for Applied Health Sciences, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Center for Applied Health Sciences | Canfield | Ohio | 44406 | United States |
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| AmaTea Guayusa Extract |
| Dietary Supplement |
650 mg of AmaTea Guayusa Extract, given as two capsules |
|
| Lion's Mane | Dietary Supplement | 1000 mg of Lion's Mane, given as two capsules |
|
| Happiness |
Happiness as measured by The Subjective Happiness Scale, where values can range from 4 to 28, and higher values represent greater happiness. |
| Change from baseline to 60 minutes and 120 minutes. |
| Cognitive Control | Cognitive control as measured by the Go/No-go Test. | Change from baseline to 60 minutes and 120 minutes. |
| Working Memory | Working memory as measured by the N-back Test. | Change from baseline to 60 minutes and 120 minutes. |
| Attention | Attention as measured by the Serial Sevens Test. | Change from baseline to 60 minutes and 120 minutes. |
| Change from baseline to 60 minutes and 120 minutes. |
| Heart rate | Heart rate measured in beats per minute. | Change from baseline to 60 minutes and 120 minutes. |