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| Name | Class |
|---|---|
| Taipei Medical University Shuang Ho Hospital | OTHER |
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This exploratory trial investigates the effect of a chicken extract supplement on mental energy and its potential underlying mechanisms of action among healthy adults using a randomized, double-blind, placebo-controlled clinical trial design. Mental energy is a multi-dimensional construct comprising transient feelings about fatigue, vigor and motivation and cognitive performance in terms of sustained attention and reaction time.
A sub-study investigates the immediate biochemical changes after taking chicken extract.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chicken extract supplement (high-dose) | Experimental | 140ml of chicken extract supplement (high-dose) to be consumed daily for 2 weeks |
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| Chicken extract supplement (low-dose) | Experimental | 140ml of chicken extract supplement (low-dose) to be consumed daily for 2 weeks |
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| Placebo | Placebo Comparator | 140ml of placebo (caesinate) to be consumed daily for 2 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chicken extract supplement (high-dose) | Dietary Supplement | 140ml of chicken extract supplement (high-dose) to be consumed daily for 2 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Reaction time and sustained attention (composite) assessed by Cogstate Brief Battery (CBB) | At baseline and on Day 14 | |
| Reaction time assessed by Deary-Liewald reaction time task | At baseline and on Day 14 | |
| Sustained attention assessed by psychomotor vigilance test | At baseline and on Day 14 | |
| Sustained attention assessed by trail making test | At baseline and on Day 14 | |
| Fatigue assessed by Profile of Mood States (POMS) | POMS-fatigue scores range from 0 to 24, with higher score indicating greater fatigue. | Daily from baseline to Day 14 |
| Fatigue assessed by visual analogue scale (VAS) | VAS scores range from 0 to 100, with higher score indicating greater fatigue. | Daily from baseline to Day 14 |
| Vigor assessed by Profile of Mood States (POMS) | POMS-vigor scores range from 0 to 28, with the higher score indicating greater vigor. | Daily from baseline to Day 14 |
| Vigor assessed by visual analogue scale (VAS) | VAS scores range from 0 to 100, with higher score indicating greater vigor. | Daily from baseline to Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep quality measured by modified Pittsburgh Sleep Quality Index (PSQI) | In the PSQI, scores from the individual items are used to generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score, with a range of 0-21 points, with higher scores indicating poorer sleep quality. The modified PSQI measures the sleep quality in the past two weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Medical University Hospital Shuang Ho Hospital | New Taipei City | 235 | Taiwan |
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| Chicken extract supplement (low-dose) | Dietary Supplement | 140ml of chicken extract supplement (low-dose) to be consumed daily for 2 weeks |
|
| Placebo | Other | 140ml of placebo to be consumed daily for 2 weeks |
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| Motivation assessed by visual analogue scale (VAS) |
VAS scores range from 0 to 100, with higher score indicating greater motivation. |
| Daily from baseline to Day 14 |
| Cerebral blood flow using arterial spin labelling magnetic resonance imaging (MRI) | At baseline and on Day 14 |
| Cerebral oxygenation using functional MRI blood oxygenation level dependent (BOLD) imaging | At baseline and on Day 14 |
| Whole body metabolic rate using indirect calorimetry | Resting body metabolic rate will be measured | At baseline and on Day 14 |
| Plasma global metabolome (metabolic profile) using liquid chromatography mass spectrometry (LCMS) | Plasma samples will be analyzed to putatively identify biomarkers of product intake by comparison of test group with control group using high-performance liquid chromatography coupled to mass spectrometer (LCMS). LCMS analysis allows the simultaneous and non-targeted analysis of a wide array of endogenous and exogenous metabolites. | At baseline and on Day 14 |
| Salivary cortisol level | At baseline and on Day 14 |
| Plasma carnosine | At baseline and on Day 14 |
| Plasma anserine | At baseline and on Day 14 |
| Plasma L-histidine | At baseline and on Day 14 |
| Plasma methylhistidine | At baseline and on Day 14 |
| Plasma beta-alanine | At baseline and on Day 14 |
| At baseline and on Day 14 |