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Completed

NCT Number: NCT06021223

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

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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Key information

Conditions

Age range

35 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Medical University Hospital Shuang Ho Hospital

New Taipei City, 235, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chicken extract supplement (high-dose)

Dietary Supplement

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

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

Primary outcomes

  1. Reaction time and sustained attention (composite) assessed by Cogstate Brief Battery (CBB)

    Time frame: At baseline and on Day 14

  2. Reaction time assessed by Deary-Liewald reaction time task

    Time frame: At baseline and on Day 14

  3. Sustained attention assessed by psychomotor vigilance test

    Time frame: At baseline and on Day 14

  4. Sustained attention assessed by trail making test

    Time frame: At baseline and on Day 14

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. Cerebral blood flow using arterial spin labelling magnetic resonance imaging (MRI)

    Time frame: At baseline and on Day 14

  11. Cerebral oxygenation using functional MRI blood oxygenation level dependent (BOLD) imaging

    Time frame: At baseline and on Day 14

  12. Whole body metabolic rate using indirect calorimetry

    Time frame: At baseline and on Day 14

    Resting body metabolic rate will be measured

  13. 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.

  14. Salivary cortisol level

    Time frame: At baseline and on Day 14

  15. Plasma carnosine

    Time frame: At baseline and on Day 14

  16. Plasma anserine

    Time frame: At baseline and on Day 14

  17. Plasma L-histidine

    Time frame: At baseline and on Day 14

  18. Plasma methylhistidine

    Time frame: At baseline and on Day 14

  19. Plasma beta-alanine

    Time frame: At baseline and on Day 14

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Brand's Suntory Asia

Industry

Collaborators

  • Taipei Medical University Shuang Ho Hospital

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 1, 2023
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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