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History of Changes for Study: NCT03128476
Effects of Essence of Chicken on Physical Fatigue, Working Memory and Attention
Latest version (submitted April 20, 2017) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 20, 2017 None (earliest Version on record)
Comparison Format:

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Study NCT03128476
Submitted Date:  April 20, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: BEC
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
Secondary IDs:
Open or close this module Study Status
Record Verification: February 2017
Overall Status: Completed
Study Start: March 3, 2016
Primary Completion: November 7, 2016 [Actual]
Study Completion: January 30, 2017 [Actual]
First Submitted: February 20, 2017
First Submitted that
Met QC Criteria:
April 20, 2017
First Posted: April 25, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
April 20, 2017
Last Update Posted: April 25, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Sprim Advanced Life Sciences
Responsible Party: Sponsor
Collaborators: Cerebos
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Healthy Subjects
Fatigue
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 364 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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)
Open or close this module Outcome Measures
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.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 45 Years
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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