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

Healthy Adults Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06021223
• Other study ID #: BEC-002
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 22, 2023
• Est. completion date: August 31, 2025

Study information

• Verified date: August 2023
• Source: Brand's Suntory Asia
• Contact: Lee Cheng Phua, PhD
• Email: leecheng.phua[@]suntory.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 189
• Est. completion date: August 31, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Adults

Intervention

Dietary Supplement:
• Chicken extract supplement (high-dose)
140ml of chicken extract supplement (high-dose) to be consumed daily for 2 weeks
• Chicken extract supplement (low-dose)
140ml of chicken extract supplement (low-dose) to be consumed daily for 2 weeks

Other:
• Placebo
140ml of placebo to be consumed daily for 2 weeks

Locations

Country	Name	City	State
Taiwan	Taipei Medical University Hospital Shuang Ho Hospital	New Taipei City

Sponsors (2)

Lead Sponsor	Collaborator
Brand's Suntory Asia	Taipei Medical University Shuang Ho Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reaction time and sustained attention (composite) assessed by Cogstate Brief Battery (CBB)		At baseline and on Day 14
Primary	Reaction time assessed by Deary-Liewald reaction time task		At baseline and on Day 14
Primary	Sustained attention assessed by psychomotor vigilance test		At baseline and on Day 14
Primary	Sustained attention assessed by trail making test		At baseline and on Day 14
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Cerebral blood flow using arterial spin labelling magnetic resonance imaging (MRI)		At baseline and on Day 14
Primary	Cerebral oxygenation using functional MRI blood oxygenation level dependent (BOLD) imaging		At baseline and on Day 14
Primary	Whole body metabolic rate using indirect calorimetry	Resting body metabolic rate will be measured	At baseline and on Day 14
Primary	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
Primary	Salivary cortisol level		At baseline and on Day 14
Primary	Plasma carnosine		At baseline and on Day 14
Primary	Plasma anserine		At baseline and on Day 14
Primary	Plasma L-histidine		At baseline and on Day 14
Primary	Plasma methylhistidine		At baseline and on Day 14
Primary	Plasma beta-alanine		At baseline and on Day 14
Secondary	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