Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Healthy Subjects Fatigue Dietary Supplement: Essence of Chicken Dietary Supplement: Placebo (Energy matched) Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 364 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of the Supplementation of Essence of Chicken on Physical Fatigue and Brain Functions Such as Working Memory and Attention Among Healthy Adults
Actual Study Start Date : March 3, 2016
Actual Primary Completion Date : November 7, 2016
Actual Study Completion Date : January 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue Memory

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: 1 bottle 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.
Active Comparator: 2 bottles 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.
Placebo Comparator: Placebo Dietary Supplement: Placebo (Energy matched)


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Fatigue-vitality [ Time Frame: 4 weeks ]
    Psychometric tests SF-36 (score 100%)

  2. Physical fatigue [ Time Frame: 4 weeks ]
    Chalder Fatigue Questionnaire (score 0-33)

  3. Attention [ Time Frame: 4 weeks ]
    Stroop (mean latency and proportion correct)

  4. Sustained attention [ Time Frame: 4 weeks ]
    Sustained Attention to Response Task (mean latency and % of correct trials)

  5. Working memory [ Time Frame: 4 weeks ]
    Digit Span test (Maximal FORWARD digit span and Maximal BACKWARD digit span, etc)


Secondary Outcome Measures :
  1. Mood [ Time Frame: 4 weeks ]
    POMS brief is used as a psychometric test to measure mood (6 domains).

  2. Stress [ Time Frame: 4 weeks ]
    DASS is used as a psychometric test to measure stress (score 0-42).

  3. Adverse effects [ Time Frame: 4 weeks ]
    Comparison of adverse events on IP and placebo groups.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Sprim Advanced Life Sciences
ClinicalTrials.gov Identifier: NCT03128476    
Other Study ID Numbers: BEC
First Posted: April 25, 2017    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: February 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Fatigue