The Effects of Chicken Extract on Mental Energy in Healthy Adults and the Underlying Mechanisms

Study Overview
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Brief Summary
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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.

Official Title
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Trial of a Chicken Extract for Improving Mental Energy and Mechanisms of Action in Healthy Adults: A Randomized, Double-blind, Placebo-controlled Exploratory Study

Conditions
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Healthy Adults

Intervention / Treatment
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* Dietary Supplement: Chicken extract supplement (high-dose)
* Dietary Supplement: Chicken extract supplement (low-dose)
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female at 35-64 years of age Assessed by investigator to be in good health Normal cognition based on investigator's clinical judgement per the routine practice Modified PSQI score > 5 Agree to participate in the study and provide written informed consent Agree to abstain from herbal extracts or dietary supplements throughout the study period Exclusion Criteria: BMI < 18.5 or ≥ 27 kg/m2 Concurrent pharmacological treatments Current systemic diseases or current/history of neurological or cerebrovascular diseases Active peptic ulcer, or a history of peptic ulcer within the last 2 years Medications or interventions in the last 4 weeks, which in the investigators' judgement could potentially affect the outcome measures Regular significant quantities of dietary supplements or herbal extracts (> 2 times a week) in the last 4 weeks Regular excessive caffeine consumption, heavy alcohol consumption or heavy habitual smokers Any drastic changes in lifestyle (including diet, smoking, sleep, exercise, and mental and physical activities) in the last 4 weeks Not able to maintain the same lifestyle throughout the study period Inadequate visual and auditory acuity to allow neuropsychological testing per investigator's judgment Inability to undergo fMRI scan Any consumption of chicken extract supplement, or carnosine or anserine supplement, in the preceding 4 weeks History of allergy to caseinate, milk, or chicken meat Women who are pregnant or lactating or intending to do so Current enrolment in another interventional study Subjects who show unstable sleep habits during the previous month Excessive blood donation or blood drawn prior to baseline

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chicken extract supplement (high-dose)<br>140ml of chicken extract supplement (high-dose) to be consumed daily for 2 weeks | Dietary Supplement: Chicken extract supplement (high-dose)<br>* 140ml of chicken extract supplement (high-dose) to be consumed daily for 2 weeks<br>|
| Experimental: Chicken extract supplement (low-dose)<br>140ml of chicken extract supplement (low-dose) to be consumed daily for 2 weeks | Dietary Supplement: Chicken extract supplement (low-dose)<br>* 140ml of chicken extract supplement (low-dose) to be consumed daily for 2 weeks<br>|
| Placebo Comparator: Placebo<br>140ml of placebo (caesinate) to be consumed daily for 2 weeks | Other: Placebo<br>* 140ml of placebo to be consumed daily for 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | At baseline and on Day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mental energy, Chicken extract, Mechanisms