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| Name | Class |
|---|---|
| Enovate Biolife Pvt Ltd | INDUSTRY |
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The current study is design to asses the effect of E-AG-01/ E-AG-02/ E-AG-03 on mental alertness as compared to placebo.
Intake of caffeinated drinks is known to improve energy levels, alertness, and concentration levels. Caffeine is a stimulant of central nervous system and therefore is probably the most commonly used psychoactive substance in the world. Caffeine intake is preferred by many individuals because moderate amount of caffeine consumption postulates certain beneficial effects on nervous system as well as on general well-being, like increase in the level of alertness and diminution in exhaustion especially in low arousal circumstances (e.g. working at night), improvements in performance on vigilance tasks and simple tasks that require sustained response. Along with these virtues caffeine intake is associated with certain demerits also. High dose of caffeine that is more than 400 mg a day in healthy adults may be associated with adverse events such as psycho motor agitation, insomnia, headache, gastrointestinal complaints depending on several other lifestyle parameters.
Since caffeine intake is habitual, withdrawal of caffeine poses certain concerns on performance like its negative impact on mood levels following its withdrawal.
Hence there is always a need to find an alternative to caffeine which has the same attributes of caffeine but is not associated with its habit forming stance. In order to fulfill this unmet need Enovate Biolife has designed a novel natural caffeine free ingredient which postulates to enhance the mental alertness and combats mental fatigue similar as caffeine without causing adverse effects associated with caffeine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E-AG-01 | Experimental | 550 mg of 2 capsules having AG-01 and AG-07 will be administered orally twice daily for one day. |
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| E-AG-02 | Experimental | 550 mg of 2 capsules having AG-05 and AG-06 will be administered orally twice daily for one day. |
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| E-AG-03 | Experimental | 550 mg of 2 capsules having AG-01 and AG-05 will be administered orally twice daily for one day. |
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| E-AG-04 | Experimental | 550 mg of 2 capsules having AG-06 and AG-07 will be administered orally twice daily for one day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AG-01 | Dietary Supplement | Product to increase mental alertness |
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| Measure | Description | Time Frame |
|---|---|---|
| Alertness | To assess the effect on mental alertness by Attention network test after ingestion of single dose of investigational product. | Five hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shalini Srivastav, M D | Enovate Biolife Pvt Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vedic Lifesciences | Mumbai | Maharashtra | 400073 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19733954 | Result | Brunye TT, Mahoney CR, Lieberman HR, Taylor HA. Caffeine modulates attention network function. Brain Cogn. 2010 Mar;72(2):181-8. doi: 10.1016/j.bandc.2009.07.013. Epub 2009 Sep 5. |
| Label | URL |
|---|---|
| Caffeine modulates attention network function: BrunyéTT1, Mahoney CR, Lieberman HR, Taylor | View source |
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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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| AG-05 |
| Dietary Supplement |
Product to increase mental alertness |
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| AG-06 | Dietary Supplement | Product to increase mental alertness |
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| AG-07 | Dietary Supplement | Product to increase mental alertness |
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| D001519 | Behavior |