Healthy SubjectsNCT03128476
Effects of Essence of Chicken on Physical Fatigue, Working Memory and Attention
A study testing Essence of Chicken in people with Healthy Subjects and Fatigue, run by Sprim Advanced Life Sciences.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects, Fatigue
- What is being tested?
- Essence of Chicken
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 364 participants
- Where
- No sites listed yet
- Study dates
- 3 Mar 2016to 30 Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
About this study
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
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
- Being tested
- Essence of Chicken, Placebo (Energy matched)
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Essence of ChickenDietary 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.
Placebo (Energy matched)Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 1 bottle | Active comparator | Not described Receives: Dietary Supplement: Essence of Chicken |
| 2 bottles | Active comparator | Not described Receives: Dietary Supplement: Essence of Chicken |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo (Energy matched) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue-vitality
Psychometric tests SF-36 (score 100%)
Measured: 4 weeks
Physical fatigue
Chalder Fatigue Questionnaire (score 0-33)
Measured: 4 weeks
Attention
Stroop (mean latency and proportion correct)
Measured: 4 weeks
Sustained attention
Sustained Attention to Response Task (mean latency and % of correct trials)
Measured: 4 weeks
Working memory
Digit Span test (Maximal FORWARD digit span and Maximal BACKWARD digit span, etc)
Measured: 4 weeks
Secondary outcomes (3)
Mood
POMS brief is used as a psychometric test to measure mood (6 domains).
Measured: 4 weeks
Stress
DASS is used as a psychometric test to measure stress (score 0-42).
Measured: 4 weeks
Adverse effects
Comparison of adverse events on IP and placebo groups.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start3 Mar 2016
- Primary completion7 Nov 2016
- Study completion30 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 364 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sprim Advanced Life Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Cerebos
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03128476
- Sponsor's protocol ID
- BEC
- Status last verified
- Feb 2017
- First submitted
- 20 Feb 2017
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03128476
- Acronym / sponsor ID
- BEC
- Conditions
- Healthy Subjects, Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 364 participants (actual)
- Lead sponsor
- Sprim Advanced Life SciencesUniversity, hospital or other
- Collaborators
- Cerebos
- Study start
- 3 Mar 2016 (actual)
- Primary completion
- 7 Nov 2016 (actual)
- Study completion
- 30 Jan 2017 (actual)
- First posted
- 25 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Essence of ChickenBrand'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 supplement | 1 bottle, 2 bottles |
| Placebo (Energy matched) | Dietary supplement | Placebo |
Primary outcome
Fatigue-vitality
Time frame: 4 weeks
Psychometric tests SF-36 (score 100%)
Physical fatigue
Time frame: 4 weeks
Chalder Fatigue Questionnaire (score 0-33)
Attention
Time frame: 4 weeks
Stroop (mean latency and proportion correct)
Sustained attention
Time frame: 4 weeks
Sustained Attention to Response Task (mean latency and % of correct trials)
Working memory
Time frame: 4 weeks
Digit Span test (Maximal FORWARD digit span and Maximal BACKWARD digit span, etc)
3 secondary outcomes
Mood
Time frame: 4 weeks
Stress
Time frame: 4 weeks
Adverse effects
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Essence of Chicken in people with Healthy Subjects and Fatigue, run by Sprim Advanced Life Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue-vitality (time frame: 4 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2017.