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

NCT03128476 | Completed DMC

• 1 other identifier: BEC
• Study Type: interventional
• Target: 364
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy Subjects; Fatigue

Outcome Measures

Primary Outcomes (5)

• Fatigue-vitality

  Psychometric tests SF-36 (score 100%)

  4 weeks

• Physical fatigue

  Chalder Fatigue Questionnaire (score 0-33)

  4 weeks

• Attention

  Stroop (mean latency and proportion correct)

  4 weeks

• Sustained attention

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

  4 weeks

• Working memory

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

  4 weeks

Secondary Outcomes (3)

• Mood

  4 weeks

• Stress

  4 weeks

• Adverse effects

  4 weeks

Study Arms (3)

1 bottle

ACTIVE COMPARATOR

Dietary Supplement: Essence of Chicken

2 bottles

ACTIVE COMPARATOR

Dietary Supplement: Essence of Chicken

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo (Energy matched)

Interventions

Essence of Chicken DIETARY_SUPPLEMENT

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.

1 bottle; 2 bottles

Placebo (Energy matched) DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Normal BMI
• Not continuously taken Essence of Chicken for the last 3 months

You may not qualify if:

• 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

Sponsors & Collaborators

• Sprim Advanced Life Sciences: lead
• Cerebos: collaborator

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2017
• First Posted: April 25, 2017
• Study Start: March 3, 2016
• Primary Completion: November 7, 2016
• Study Completion: January 30, 2017
• Last Updated: April 25, 2017

Record last verified: 2017-02