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

Primary Purpose

Healthy Subjects, Fatigue

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Essence of Chicken
Placebo (Energy matched)
Sponsored by
Sprim Advanced Life Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy Subjects

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    1 bottle

    2 bottles

    Placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    Fatigue-vitality
    Psychometric tests SF-36 (score 100%)
    Physical fatigue
    Chalder Fatigue Questionnaire (score 0-33)
    Attention
    Stroop (mean latency and proportion correct)
    Sustained attention
    Sustained Attention to Response Task (mean latency and % of correct trials)
    Working memory
    Digit Span test (Maximal FORWARD digit span and Maximal BACKWARD digit span, etc)

    Secondary Outcome Measures

    Mood
    POMS brief is used as a psychometric test to measure mood (6 domains).
    Stress
    DASS is used as a psychometric test to measure stress (score 0-42).
    Adverse effects
    Comparison of adverse events on IP and placebo groups.

    Full Information

    First Posted
    February 20, 2017
    Last Updated
    April 20, 2017
    Sponsor
    Sprim Advanced Life Sciences
    Collaborators
    Cerebos
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03128476
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    March 3, 2016 (Actual)
    Primary Completion Date
    November 7, 2016 (Actual)
    Study Completion Date
    January 30, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Sprim Advanced Life Sciences
    Collaborators
    Cerebos

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Healthy Subjects, Fatigue

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    364 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1 bottle
    Arm Type
    Active Comparator
    Arm Title
    2 bottles
    Arm Type
    Active Comparator
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Essence of Chicken
    Intervention Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo (Energy matched)
    Primary Outcome Measure Information:
    Title
    Fatigue-vitality
    Description
    Psychometric tests SF-36 (score 100%)
    Time Frame
    4 weeks
    Title
    Physical fatigue
    Description
    Chalder Fatigue Questionnaire (score 0-33)
    Time Frame
    4 weeks
    Title
    Attention
    Description
    Stroop (mean latency and proportion correct)
    Time Frame
    4 weeks
    Title
    Sustained attention
    Description
    Sustained Attention to Response Task (mean latency and % of correct trials)
    Time Frame
    4 weeks
    Title
    Working memory
    Description
    Digit Span test (Maximal FORWARD digit span and Maximal BACKWARD digit span, etc)
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Mood
    Description
    POMS brief is used as a psychometric test to measure mood (6 domains).
    Time Frame
    4 weeks
    Title
    Stress
    Description
    DASS is used as a psychometric test to measure stress (score 0-42).
    Time Frame
    4 weeks
    Title
    Adverse effects
    Description
    Comparison of adverse events on IP and placebo groups.
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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

    12. IPD Sharing Statement

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

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