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CompletedNCT03128476Updated Apr 25, 2017

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

An interventional study of Essence of Chicken and Placebo (Energy matched) in Healthy Subjects and Fatigue, sponsored by Sprim Advanced Life Sciences. Completed. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-25.

Sponsored by Sprim Advanced Life Sciences · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
364
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Subjects
  • Fatigue

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03

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
364 participants (actual)

Study arms

  • Active comparator
    1 bottle

    Dietary Supplement: Essence of Chicken

  • Active comparator
    2 bottles

    Dietary Supplement: Essence of Chicken

  • Placebo comparator
    Placebo

    Dietary Supplement: Placebo (Energy matched)

Interventions

  • Dietary supplementEssence 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 supplementPlacebo (Energy matched)
05

What researchers measure

Primary outcomes

  1. Fatigue-vitality

    Psychometric tests SF-36 (score 100%)

    Time frame: 4 weeks

  2. Physical fatigue

    Chalder Fatigue Questionnaire (score 0-33)

    Time frame: 4 weeks

  3. Attention

    Stroop (mean latency and proportion correct)

    Time frame: 4 weeks

  4. Sustained attention

    Sustained Attention to Response Task (mean latency and % of correct trials)

    Time frame: 4 weeks

  5. Working memory

    Digit Span test (Maximal FORWARD digit span and Maximal BACKWARD digit span, etc)

    Time frame: 4 weeks

Secondary outcomes

  1. Mood

    POMS brief is used as a psychometric test to measure mood (6 domains).

    Time frame: 4 weeks

  2. Stress

    DASS is used as a psychometric test to measure stress (score 0-42).

    Time frame: 4 weeks

  3. Adverse effects

    Comparison of adverse events on IP and placebo groups.

    Time frame: 4 weeks

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT03128476
Lead sponsor
Sprim Advanced Life Sciences
Collaborators
Cerebos
Responsible party
Sponsor
First posted
Apr 25, 2017
Start date
Mar 3, 2016
Primary completion
Nov 7, 2016
Completion
Jan 30, 2017
Last update
Apr 25, 2017

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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