- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06021223
The Effects of Chicken Extract on Mental Energy in Healthy Adults and the Underlying Mechanisms
Trial of a Chicken Extract for Improving Mental Energy and Mechanisms of Action in Healthy Adults: A Randomized, Double-blind, Placebo-controlled Exploratory Study
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lee Cheng Phua, PhD
- Email: leecheng.phua@suntory.com
Study Locations
-
-
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New Taipei City, Taiwan, 235
- Taipei Medical University Hospital Shuang Ho Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Chicken extract supplement (high-dose)
140ml of chicken extract supplement (high-dose) to be consumed daily for 2 weeks
|
140ml of chicken extract supplement (high-dose) to be consumed daily for 2 weeks
|
Experimental: Chicken extract supplement (low-dose)
140ml of chicken extract supplement (low-dose) to be consumed daily for 2 weeks
|
140ml of chicken extract supplement (low-dose) to be consumed daily for 2 weeks
|
Placebo Comparator: Placebo
140ml of placebo (caesinate) to be consumed daily for 2 weeks
|
140ml of placebo to be consumed daily for 2 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reaction time and sustained attention (composite) assessed by Cogstate Brief Battery (CBB)
Time Frame: At baseline and on Day 14
|
At baseline and on Day 14
|
|
Reaction time assessed by Deary-Liewald reaction time task
Time Frame: At baseline and on Day 14
|
At baseline and on Day 14
|
|
Sustained attention assessed by psychomotor vigilance test
Time Frame: At baseline and on Day 14
|
At baseline and on Day 14
|
|
Sustained attention assessed by trail making test
Time Frame: At baseline and on Day 14
|
At baseline and on Day 14
|
|
Fatigue assessed by Profile of Mood States (POMS)
Time Frame: Daily from baseline to Day 14
|
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)
Time Frame: Daily from baseline to Day 14
|
VAS scores range from 0 to 100, with higher score indicating greater fatigue.
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Daily from baseline to Day 14
|
Vigor assessed by Profile of Mood States (POMS)
Time Frame: Daily from baseline to Day 14
|
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)
Time Frame: Daily from baseline to Day 14
|
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)
Time Frame: Daily from baseline to Day 14
|
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)
Time Frame: At baseline and on Day 14
|
At baseline and on Day 14
|
|
Cerebral oxygenation using functional MRI blood oxygenation level dependent (BOLD) imaging
Time Frame: At baseline and on Day 14
|
At baseline and on Day 14
|
|
Whole body metabolic rate using indirect calorimetry
Time Frame: At baseline and on Day 14
|
Resting body metabolic rate will be measured
|
At baseline and on Day 14
|
Plasma global metabolome (metabolic profile) using liquid chromatography mass spectrometry (LCMS)
Time Frame: At baseline and on Day 14
|
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
Time Frame: At baseline and on Day 14
|
At baseline and on Day 14
|
|
Plasma carnosine
Time Frame: At baseline and on Day 14
|
At baseline and on Day 14
|
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Plasma anserine
Time Frame: At baseline and on Day 14
|
At baseline and on Day 14
|
|
Plasma L-histidine
Time Frame: At baseline and on Day 14
|
At baseline and on Day 14
|
|
Plasma methylhistidine
Time Frame: At baseline and on Day 14
|
At baseline and on Day 14
|
|
Plasma beta-alanine
Time Frame: At baseline and on Day 14
|
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)
Time Frame: At baseline and on Day 14
|
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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At baseline and on Day 14
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- BEC-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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