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

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

Tracking Information

• First Submitted Date: February 20, 2017
• First Posted Date: April 25, 2017
• Last Update Posted Date: April 25, 2017
• Actual Study Start Date: March 3, 2016
• Actual Primary Completion Date: November 7, 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effects of Essence of Chicken on Physical Fatigue, Working Memory and Attention
• 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

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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Healthy Subjects
• Fatigue

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 20, 2017): 364
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: January 30, 2017
• Actual Primary Completion Date: November 7, 2016 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03128476
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: Sprim Advanced Life Sciences
• Original Responsible Party: Same as current
• Current Study Sponsor: Sprim Advanced Life Sciences
• Original Study Sponsor: Same as current
• Collaborators: Cerebos
• Investigators: Not Provided
• PRS Account: Sprim Advanced Life Sciences
• Verification Date: February 2017