- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03128476
Effects of Essence of Chicken on Physical Fatigue, Working Memory and Attention
Effects of the Supplementation of Essence of Chicken on Physical Fatigue and Brain Functions Such as Working Memory and Attention Among Healthy Adults
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo
|
|
|
Active Comparator: 1 bottle
|
Brand's Essence of Chicken (BEC) is produced via a water extraction process from chicken meat for several hours under high-temperature, followed by centrifugation to remove fat and cholesterol, vacuum concentration to 3- to 4-fold, sterilization by high temperature and pressure before bottling.
This kind of chicken essence is rich in protein, and low in sugar and fat, conveniently available and consumable, and easy for household storage.
|
|
Active Comparator: 2 bottles
|
Brand's Essence of Chicken (BEC) is produced via a water extraction process from chicken meat for several hours under high-temperature, followed by centrifugation to remove fat and cholesterol, vacuum concentration to 3- to 4-fold, sterilization by high temperature and pressure before bottling.
This kind of chicken essence is rich in protein, and low in sugar and fat, conveniently available and consumable, and easy for household storage.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fatigue-vitality
Time Frame: 4 weeks
|
Psychometric tests SF-36 (score 100%)
|
4 weeks
|
|
Physical fatigue
Time Frame: 4 weeks
|
Chalder Fatigue Questionnaire (score 0-33)
|
4 weeks
|
|
Attention
Time Frame: 4 weeks
|
Stroop (mean latency and proportion correct)
|
4 weeks
|
|
Sustained attention
Time Frame: 4 weeks
|
Sustained Attention to Response Task (mean latency and % of correct trials)
|
4 weeks
|
|
Working memory
Time Frame: 4 weeks
|
Digit Span test (Maximal FORWARD digit span and Maximal BACKWARD digit span, etc)
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mood
Time Frame: 4 weeks
|
POMS brief is used as a psychometric test to measure mood (6 domains).
|
4 weeks
|
|
Stress
Time Frame: 4 weeks
|
DASS is used as a psychometric test to measure stress (score 0-42).
|
4 weeks
|
|
Adverse effects
Time Frame: 4 weeks
|
Comparison of adverse events on IP and placebo groups.
|
4 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BEC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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