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The primary aim of this randomised, double-blind, placebo-controlled, cross-over study is to assess the short-term cognitive effects of a single dose (300 mg) of Mango Leaf Extract compared to a placebo on cognitive function, including during cognitively demanding task performance. The trial will utilise the COMPASS cognitive assessment system and cognitive demand battery (CDB), and Profile of Mood States (POMS), visual analogue mood scales (VAMS), and Stress Visual Analogue Scales (S-VAS) with assessments taking place at baseline, 30 minutes, 180 minutes and 300 minutes post treatment, on two separate testing days separated by 7 days (minimum).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active capsule | Experimental | Colored capsule containing 300 mg mango leaf extract (Zynamite®) standardized to contain ≥ 60% mangiferin. Supplied by PLT Health Solutions, Inc. |
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| Placebo capsule | Placebo Comparator | Colored capsule, appearance-matched to the active experimental capsule |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mango leaf extract capsule | Other | Single dose |
| |
| Placebo capsule |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of attention | Average % correct of attention tasks - choice reaction time, digit vigilance and 3 x rapid visual information processing task). Higher accuracy is better. | Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo |
| Measure | Description | Time Frame |
|---|---|---|
| General mood and psychological state, including depression and anxiety: VAMS | Visual Analogue Mood Scales (VAMS). Current subjective position marked on 100 mm lines anchored at either end by 18 antonyms (e.g. 'alert-inattentive', 'lethargic-energetic'). Better mood scores are a better outcome. | Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fiona Dodd, PhD | U. Northumbria, Brain Performance and Nutrition Research Centre, Department of Psychology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northumbria University, Brain Performance and Nutrition Research Centre | Newcastle upon Tyne | NE1 8ST | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38665302 | Derived | Dodd FL, Kennedy DO, Johnson J, Haworth E, Greener JP, Jackson PA. Acute effects of mango leaf extract on cognitive function in healthy adults: a randomised, double-blind, placebo-controlled crossover study. Front Nutr. 2024 Apr 11;11:1298807. doi: 10.3389/fnut.2024.1298807. eCollection 2024. |
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Capsules will disguise potential differences in colour/particle size of powders
| Other |
Single dose |
|
| General mood and psychological state, including depression and anxiety: POMS | Profile of Mood States (POMS) consisting of 65 adjectives rated on a 0-4 scale. Better mood scores are a better outcome. | Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo |
| General mood and psychological state, including depression and anxiety: S-VAS | Stress Visual Analogue Mood Scales (S-VAS). Four items (anxious, stressed, relaxed, calm) rated not at all to extremely on 100 mm lines. Better mood scores are a better outcome. | Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo |
| Cognitive domain factor scores | Composite cognitive factors (speed of attention, working memory, speed of memory and episodic memory) averaged across individual tasks. Higher scores are better. | Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo |
| Global cognitive performance measures: Speed | Speed of cognitive performance comprising reaction time (msec) data averaged from all of the computerized cognitive assessment tasks that return speed data. Faster average speed is a better outcome. | Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo |
| Global cognitive performance measures: Accuracy | Accuracy of cognitive performance comprising % accuracy data averaged from all of the computerized cognitive assessment tasks that return accuracy data. Higher average % accuracy is a better outcome. | Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo |
| Cognitive performance: Episodic long term memory | A computerized series of individual cognitive tasks are presented on screen. Test components are word recall, word recognition and picture recognition. Better task performance is a better outcome. | Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo |
| Cognitive performance: Attention | A computerized series of individual cognitive tasks are presented on screen. Test components are choice reaction time, digit vigilance and simple reaction time. Better task performance is a better outcome. | Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo |
| Cognitive performance: Working memory | A computerized series of individual cognitive tasks are presented on screen. Test components are numeric working memory and corsi blocks. Better task performance is a better outcome. | Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo |
| Cognitive performance: Executive function | A computerized peg and ball cognitive task is presented on screen. Better task performance is a better outcome. | Change from pre-dose (baseline) to 30, 180 and 300 minutes post-treatment, comparing mango leaf to placebo |
| Cognitive function and mental fatigue during extended performance of cognitively demanding tasks | Cognitive Demand Battery (CDB) of component tasks: Serial 3s/7s, Rapid Visual Information Processing task (RVIP), Mental Fatigue Visual Analog Scale (VAS). 30 minute test (10 minute computerized assessment run three times in succession). Higher function and lower fatigue are better outcomes. | 30, 180 and 300 minutes post-dose compared to placebo |