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| Name | Class |
|---|---|
| HCD Research | INDUSTRY |
| British American Tobacco (Investments) Limited | INDUSTRY |
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This is a single center, randomized, double blind, placebo-controlled, crossover study to determine the acute effect of a developmental dietary supplement liquid shot product on cognitive task performance and perceived effect measures related to mood and mental energy. The study will be conducted in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo 60 ml Shot, matched in volume, taste and colour and did not contain any active ingredients. 1 shot to be consumed per session |
|
| Functional Energy shot | Experimental | 60ml functional energy shot contained a proprietary blend of caffeine, ginseng, vitamins and taurine. 1 shot to be consumed per session |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo shot | Dietary Supplement | 60ml shot served in an amber bottle and consumed after 40 minutes of baseline assessments |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mental energy via Cognitive Demand Battery (CDB) Performance Index; for the functional energy shot versus placebo shot. | CDB performance index score is a comprised averaged Z scores for the principal performance measure for each of the three tasks: Rapid Visual Information Processing (RVIP) % accuracy, Serial 3s total number correct, Serial 7s total number correct. A higher score signifies performance improvement. Objective tests within Computerised Mental Performance Assessment framework tasks (COMPASS) | Change from baseline to 120 min post- shot consumption |
| Measure | Description | Time Frame |
|---|---|---|
| Mental energy via Cognitive Demand Battery (CDB) Accuracy score for the functional energy shot versus placebo shot. | CDB accuracy score is a comprised averaged Z scores for the principal measures of accuracy of performance for the three tasks: Rapid Visual Information Processing (RVIP) % accuracy; Serial 3s % errors; Serial 7s % errors (the latter two were inverted so that a higher Z score related to better accuracy). A higher score signifies performance improvement. Objective tests within Computerised Mental Performance Assessment framework tasks (COMPASS) |
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Inclusion Criteria:
MAIN INCLUSION CRITERIA:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle M Niedziela, PhD | HCD Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schlesinger Group New Jersey | Iselin | New Jersey | 08330 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39850336 | Derived | O'Shea OK, Lawley N, Azzopardi A, Gutkowski A, Niedziela MM, Horn R, Kennedy DO, Adamson J. Acute beneficial effects of a functional energy shot on cognitive performance and mood states during cognitively demanding task performance: a randomized, double-blind, placebo-controlled, crossover trial. Front Nutr. 2025 Jan 9;11:1496092. doi: 10.3389/fnut.2024.1496092. eCollection 2024. |
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| ID | Term |
|---|---|
| D005222 | Mental Fatigue |
| ID | Term |
|---|---|
| D005221 | Fatigue |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
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| Functional energy shot | Dietary Supplement | 60ml shot served in an amber bottle and consumed after 40 minutes of baseline assessments |
|
| Change from baseline to 120 min post- shot consumption |
| Change in performance on Corsi blocks task for functional energy shot versus placebo | Objective tests within Computerised Mental Performance Assessment framework tasks (COMPASS) | Change from baseline to 120 min post- shot consumption |
| Change in performance on Rapid Visual Information Processing (RVIP) for functional energy shot versus placebo | Objective tests within Computerised Mental Performance Assessment framework tasks (COMPASS) | Change from baseline to 120 min post- shot consumption |
| Change in performance on Numeric working memory for functional energy shot versus placebo | Objective tests within Computerised Mental Performance Assessment framework tasks (COMPASS) | Change from baseline to 120 min post- shot consumption |
| Change in performance on Serial subtraction task for functional energy shot versus placebo | Objective tests within Computerised Mental Performance Assessment framework tasks (COMPASS) | Change from baseline to 120 min post- shot consumption |
| Change in Mood via Visual Analogue Scales (VAS) during Cognitive Demand Battery (CDB), for functional energy shot versus placebo | 0-100 mm subjective rating scale from none to strongest feelings, within Computerised Mental Performance Assessment framework tasks (COMPASS) for mental fatigue, alert, sociable, simulated, jittery, physical energy. The minimum score is 0 and the maximum score is 100. | Change from baseline to 120 min post- shot consumption |
| Change in physiological state via Profile Of Mood States (POMS) during Cognitive Demand Battery (CDB), for functional energy shot versus placebo | a 37-item inventory, the individual item scores of which are collapsed into six dimensions of mood: anger/hostility, confusion/bewilderment, depression/dejection, fatigue/inertia, tension/anxiety, and vigour/activity. | Change from baseline to 120 min post- shot consumption |
| D001519 | Behavior |