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临床试验/NCT03128476
NCT03128476已完成不适用

Effects of the Supplementation of Essence of Chicken on Physical Fatigue and Brain Functions Such as Working Memory and Attention Among Healthy Adults

Sprim Advanced Life Sciences0 个研究点目标入组 364 人开始时间: 2016年3月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
364
主要终点
Fatigue-vitality

研究概览

简要总结

In Southeast Asia, Essence of Chicken, a chicken-meat-extract, is a popular beverage and is consumed as a traditional remedy for several ailments, including the use as a nutritional supplement for sickness, enhancement of mental efficiency, and recovery from mental fatigue. While the elderly use it as a nutritional supplement, students use it for relief from anxiety during exam times.

The present study is conducted in order to assess the effects of BEC on various physical and mental parameters including physical fatigue, working memory and attention, mood and stress, in comparison to placebo.

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
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Normal BMI
  • •Not continuously taken Essence of Chicken for the last 3 months
  • •Physical and psychological fatigue inclusion criteria/test/cutoff using CFQ (where individuals' CFQ scores 4 or above)

排除标准

  • •Suffering from chronic or malignant diseases e.g. cancer, heart, liver, renal or other metabolic diseases.
  • •Any psychiatric or neurological disease
  • •Pregnant and lactating women
  • •Subjects participated in any investigational drug trial within 4 weeks before screening
  • •Consumption of food supplement in the previous 2 weeks
  • •Professional athletes
  • •Subjects with recent lifestyle changes in the past 4 weeks
  • •History of allergy to chicken meat and seafood

研究组 & 干预措施

1 bottle

Active Comparator

干预措施: Essence of Chicken (Dietary Supplement)

2 bottles

Active Comparator

干预措施: Essence of Chicken (Dietary Supplement)

Placebo

Placebo Comparator

干预措施: Placebo (Energy matched) (Dietary Supplement)

结局指标

主要结局

Fatigue-vitality

时间窗: 4 weeks

Psychometric tests SF-36 (score 100%)

Attention

时间窗: 4 weeks

Stroop (mean latency and proportion correct)

Physical fatigue

时间窗: 4 weeks

Chalder Fatigue Questionnaire (score 0-33)

Sustained attention

时间窗: 4 weeks

Sustained Attention to Response Task (mean latency and % of correct trials)

Working memory

时间窗: 4 weeks

Digit Span test (Maximal FORWARD digit span and Maximal BACKWARD digit span, etc)

次要结局

  • Mood(4 weeks)
  • Adverse effects(4 weeks)
  • Stress(4 weeks)

研究者

发起方
Sprim Advanced Life Sciences
申办方类型
Other
责任方
Sponsor

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