NCT06021223

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
189

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

August 22, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 1, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2025

Completed
Last Updated

September 16, 2025

Status Verified

January 1, 2025

Enrollment Period

1.4 years

First QC Date

August 22, 2023

Last Update Submit

September 10, 2025

Conditions

Healthy Adults

Keywords

Mental energyChicken extractMechanisms

Outcome Measures

Primary Outcomes (19)

  • 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 Outcomes (1)

  • Sleep quality measured by modified Pittsburgh Sleep Quality Index (PSQI)

    At baseline and on Day 14

Study Arms (3)

Chicken extract supplement (high-dose)

EXPERIMENTAL

140ml of chicken extract supplement (high-dose) to be consumed daily for 2 weeks

Dietary Supplement: Chicken extract supplement (high-dose)

Chicken extract supplement (low-dose)

EXPERIMENTAL

140ml of chicken extract supplement (low-dose) to be consumed daily for 2 weeks

Dietary Supplement: Chicken extract supplement (low-dose)

Placebo

PLACEBO COMPARATOR

140ml of placebo (caesinate) to be consumed daily for 2 weeks

Other: Placebo

Interventions

Chicken extract supplement (high-dose)DIETARY_SUPPLEMENT

140ml of chicken extract supplement (high-dose) to be consumed daily for 2 weeks

Chicken extract supplement (high-dose)
Chicken extract supplement (low-dose)DIETARY_SUPPLEMENT

140ml of chicken extract supplement (low-dose) to be consumed daily for 2 weeks

Chicken extract supplement (low-dose)
PlaceboOTHER

140ml of placebo to be consumed daily for 2 weeks

Placebo

Eligibility Criteria

Age35 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University Hospital Shuang Ho Hospital

New Taipei City, 235, Taiwan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2023

First Posted

September 1, 2023

Study Start

August 22, 2023

Primary Completion

January 8, 2025

Study Completion

January 8, 2025

Last Updated

September 16, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)