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The primary objective of this randomized, double-blind, placebo-controlled, cross-over study is to assess the acute effects of a novel ingredient, guayusa on alertness and mental fatigue compared to a placebo. This trial will utilize the COMPASS cognitive task and cognitive demand battery (CDB) and mood, motivation, and energy measures with assessments taking place at baseline, 60- and 120-minutes post treatment on three separate testing days separated by ~7 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active capsule 1: Lower dose guayusa ingredient | Experimental | Oral administration of 175 mg guayusa extract providing 35 mg caffeine |
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| Active capsule 2: Higher dose guayusa ingredient | Experimental | Oral administration of 300 mg guayusa extract providing 60 mg caffeine |
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| Placebo capsule | Placebo Comparator | Oral administration of 0 mg guayusa extract, 0 mg caffeine. Capsule color-matched to actives 1 and 2 to disguise potential differences in color of contents. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gel capsule | Other | Single capsule per dose |
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| Measure | Description | Time Frame |
|---|---|---|
| Mental alertness | Current subjective alertness rating on a Visual Analog Scale (VAS) in the COMPASS Cognitive Demand Battery (CDB) by marking on a 100-mm line with the end points labelled "not at all" (left hand end) and "extremely" (right hand end). Scores are calculated as percentage along the line from left to right. Increased alertness is better. | Change from pre-dose baseline to 60 minutes post-guayusa consumption compared to placebo |
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| Measure | Description | Time Frame |
|---|---|---|
| Mental alertness | Current subjective alertness rating on a Visual Analog Scale (VAS) in the COMPASS Cognitive Demand Battery (CDB) by marking on a 100-mm line with the end points labelled "not at all" (left hand end) and "extremely" (right hand end). Scores are calculated as percentage along the line from left to right. Increased alertness is better. | Change from pre-dose baseline to 120 minutes post-guayusa consumption compared to placebo. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dawn Beckman, MD | Mérieux NutriSciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biofortis Innovation Services, Division of Merieux NutriSciences | Addison | Illinois | 60101 | United States |
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| ID | Term |
|---|---|
| D005222 | Mental Fatigue |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D005782 | Gels |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| Mental fatigue | Current subjective alertness rating on a Visual Analog Scale (VAS) in the COMPASS Cognitive Demand Battery (CDB) by marking on a 100-mm line with the end points labelled "not at all" (left hand end) and "extremely" (right hand end). Scores are calculated as percentage along the line from left to right. Decreased mental fatigue is better. | Change from pre-dose baseline to 60 minutes and 120 minutes post-guayusa consumption compared to placebo |
| Energy & Fatigue State (EFS) Scales | Rating of current subjective feelings from none to strongest ever felt for physical energy, physical fatigue, mental energy, and mental fatigue. Each EFS-State scale dimension is comprised of answers from three items that are presented and then summed to composite scores ranging from 0 to 300 in the COMPASS Cognitive Demand Battery (CDB). Increased energy and lower fatigue is better. | Change from pre-dose baseline to 60 minutes and 120 minutes post-guayusa consumption compared to placebo |
| Mood | Bond-Lader Visual Analog Scale (VAS) in the COMPASS Cognitive Demand Battery, (CDB). 16 scales anchored at either side by an adjective describing a mood, to click at a point on the scale that represents the feeling at that point in time, scored from 0-100. From these 16 scales, three composite scores are calculated describing feelings of 'Alert', 'Calm' and 'Content'. Improved mood is better. | Change from pre-dose baseline to 60 minutes and 120 minutes post-guayusa consumption compared to placebo |
| Cognitive test Serial Subtraction | Serial 3s and Serials 7s in the COMPASS Cognitive Demand Battery (CDB). A random starting number (between 800 and 999) is displayed on the screen. Participants are required to subtract a number (e.g. 7s or 3s) from this and continue to subtract from the resultant numbers for the duration of the task. Higher accuracy is better. | Change from pre-dose baseline to 60 minutes and 120 minutes post-guayusa consumption compared to placebo |
| Cognitive test RVIP | Rapid Visual Information Processing (RVIP) in the COMPASS Cognitive Demand Battery (CDB). A series of numbers are displayed individually on the screen in quick succession (at a rate of 100 numbers per minute) and participants are required to respond when they see 3 odd numbers in a row or 3 even numbers in a row. Higher accuracy is better. | Change from pre-dose baseline to 60 minutes and 120 minutes post-guayusa consumption compared to placebo |
| Cognitive memory test: Words | Accuracy and reaction time for delayed word recall and delayed word recognition in the COMPASS Cognitive Demand Battery (CDB). Higher accuracy and faster reaction time are better. | Change from pre-dose baseline to 60 minutes and 120 minutes post-guayusa consumption compared to placebo |
| Cognitive memory test: Pictures | Accuracy and reaction time for delayed picture recognition in the COMPASS Cognitive Demand Battery (CDB). Higher accuracy and faster reaction time is better. | Change from pre-dose baseline to 60 minutes and 120 minutes post-guayusa consumption compared to placebo |