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

Brand's Suntory Asia2 个研究点分布在 1 个国家目标入组 189 人开始时间: 2023年8月22日最近更新: 2025年9月16日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 189
试验地点: 2
主要终点: Fatigue assessed by visual analogue scale (VAS)

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围: 35 Years 至 64 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•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

排除标准

•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

结局指标

主要结局

Fatigue assessed by visual analogue scale (VAS)

时间窗: Daily from baseline to Day 14

VAS scores range from 0 to 100, with higher score indicating greater fatigue.

Vigor assessed by visual analogue scale (VAS)

时间窗: Daily from baseline to Day 14

VAS scores range from 0 to 100, with higher score indicating greater vigor.

Reaction time assessed by Deary-Liewald reaction time task