Clinical trial NCT06021223: The Effects of Chicken Extract on Mental Energy in Healthy Adults and the Underlying Mechanisms
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy Adults
Keywords: Mental energy
Chicken extract
Mechanisms
Lead sponsor: Brand's Suntory Asia
Sponsor class: INDUSTRY
Collaborators: name: Taipei Medical University Shuang Ho Hospital
First posted: 2023-09-01
Enrollment: 189
Sex: ALL
Minimum age (years): 35
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Reaction time and sustained attention (composite) assessed by Cogstate Brief Battery (CBB)
timeFrame: At baseline and on Day 14
measure: Reaction time assessed by Deary-Liewald reaction time task
timeFrame: At baseline and on Day 14
measure: Sustained attention assessed by psychomotor vigilance test
timeFrame: At baseline and on Day 14
measure: Sustained attention assessed by trail making test
timeFrame: At baseline and on Day 14
measure: Fatigue assessed by Profile of Mood States (POMS)
timeFrame: Daily from baseline to Day 14
measure: Fatigue assessed by visual analogue scale (VAS)
timeFrame: Daily from baseline to Day 14
measure: Vigor assessed by Profile of Mood States (POMS)
timeFrame: Daily from baseline to Day 14
measure: Vigor assessed by visual analogue scale (VAS)
timeFrame: Daily from baseline to Day 14
measure: Motivation assessed by visual analogue scale (VAS)
timeFrame: Daily from baseline to Day 14
measure: Cerebral blood flow using arterial spin labelling magnetic resonance imaging (MRI)
timeFrame: At baseline and on Day 14
measure: Cerebral oxygenation using functional MRI blood oxygenation level dependent (BOLD) imaging
timeFrame: At baseline and on Day 14
measure: Whole body metabolic rate using indirect calorimetry
timeFrame: At baseline and on Day 14
measure: Plasma global metabolome (metabolic profile) using liquid chromatography mass spectrometry (LCMS)
timeFrame: At baseline and on Day 14
measure: Salivary cortisol level
timeFrame: At baseline and on Day 14
measure: Plasma carnosine
timeFrame: At baseline and on Day 14
measure: Plasma anserine
timeFrame: At baseline and on Day 14
measure: Plasma L-histidine
timeFrame: At baseline and on Day 14
measure: Plasma methylhistidine
timeFrame: At baseline and on Day 14
measure: Plasma beta-alanine
timeFrame: At baseline and on Day 14
Secondary outcomes:
measure: Sleep quality measured by modified Pittsburgh Sleep Quality Index (PSQI)
timeFrame: At baseline and on Day 14
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Taipei Medical University Hospital Shuang Ho Hospital
Study officials:
References: