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Effects of Essence of Chicken on Physical Fatigue, Working Memory and Attention

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ClinicalTrials.gov Identifier: NCT03128476
Recruitment Status : Completed
First Posted : April 25, 2017
Last Update Posted : April 25, 2017
Sponsor:
Collaborator:
Cerebos
Information provided by (Responsible Party):
Sprim Advanced Life Sciences

Tracking Information
First Submitted Date  ICMJE February 20, 2017
First Posted Date  ICMJE April 25, 2017
Last Update Posted Date April 25, 2017
Actual Study Start Date  ICMJE March 3, 2016
Actual Primary Completion Date November 7, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2017)
  • Fatigue-vitality [ Time Frame: 4 weeks ]
    Psychometric tests SF-36 (score 100%)
  • Physical fatigue [ Time Frame: 4 weeks ]
    Chalder Fatigue Questionnaire (score 0-33)
  • Attention [ Time Frame: 4 weeks ]
    Stroop (mean latency and proportion correct)
  • Sustained attention [ Time Frame: 4 weeks ]
    Sustained Attention to Response Task (mean latency and % of correct trials)
  • Working memory [ Time Frame: 4 weeks ]
    Digit Span test (Maximal FORWARD digit span and Maximal BACKWARD digit span, etc)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2017)
  • Mood [ Time Frame: 4 weeks ]
    POMS brief is used as a psychometric test to measure mood (6 domains).
  • Stress [ Time Frame: 4 weeks ]
    DASS is used as a psychometric test to measure stress (score 0-42).
  • Adverse effects [ Time Frame: 4 weeks ]
    Comparison of adverse events on IP and placebo groups.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Essence of Chicken on Physical Fatigue, Working Memory and Attention
Official Title  ICMJE Effects of the Supplementation of Essence of Chicken on Physical Fatigue and Brain Functions Such as Working Memory and Attention Among Healthy Adults
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Healthy Subjects
  • Fatigue
Intervention  ICMJE
  • Dietary Supplement: Essence of Chicken
    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.
  • Dietary Supplement: Placebo (Energy matched)
Study Arms  ICMJE
  • Active Comparator: 1 bottle
    Intervention: Dietary Supplement: Essence of Chicken
  • Active Comparator: 2 bottles
    Intervention: Dietary Supplement: Essence of Chicken
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Placebo (Energy matched)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 20, 2017)
364
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 30, 2017
Actual Primary Completion Date November 7, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03128476
Other Study ID Numbers  ICMJE BEC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Sprim Advanced Life Sciences
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Sprim Advanced Life Sciences
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Cerebos
Investigators  ICMJE Not Provided
PRS Account Sprim Advanced Life Sciences
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP