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

Healthy Subjects Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03128476
• Other study ID #: BEC
• Status: Completed
• Phase: N/A
• First received: February 20, 2017
• Last updated: April 20, 2017
• Start date: March 3, 2016
• Est. completion date: January 30, 2017

Study information

• Verified date: February 2017
• Source: Sprim Advanced Life Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 364
• Est. completion date: January 30, 2017
• Est. primary completion date: November 7, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Healthy Subjects

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.
• Placebo (Energy matched)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Sprim Advanced Life Sciences	Cerebos

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue-vitality	Psychometric tests SF-36 (score 100%)	4 weeks
Primary	Physical fatigue	Chalder Fatigue Questionnaire (score 0-33)	4 weeks
Primary	Attention	Stroop (mean latency and proportion correct)	4 weeks
Primary	Sustained attention	Sustained Attention to Response Task (mean latency and % of correct trials)	4 weeks
Primary	Working memory	Digit Span test (Maximal FORWARD digit span and Maximal BACKWARD digit span, etc)	4 weeks
Secondary	Mood	POMS brief is used as a psychometric test to measure mood (6 domains).	4 weeks
Secondary	Stress	DASS is used as a psychometric test to measure stress (score 0-42).	4 weeks
Secondary	Adverse effects	Comparison of adverse events on IP and placebo groups.	4 weeks