Stress Associated Cognitive InhibitionNCT02166931
BRAND'S® Essence of Chicken in the Promotion of Resilience and Resistance to Stress-associated Cognitive Inhibition
A study testing Chicken Essence in people with Stress Associated Cognitive Inhibition and Essence of Chicken, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to determine whether BRAND'S® Essence of Chicken are effective in the promotion of resilience and resistance to stress-associated cognitive inhibition. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress Associated Cognitive Inhibition, Essence of Chicken, Cognition
- What is being tested?
- Chicken Essence
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2014to 18 Sep 2019
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged over 20 years,
- mildly stressed with Perceive Stress Scale (PSS) score higher than 25
- All the participants should not require medication for their mood disturbance affected by stress during the trial.
Who cannot join
- history of chronic diseases
- any psychiatric or neurological diseases (e.g. depression)
- other medical illnesses (e.g. stroke, diabetes, other cardiovascular diseases)
- allergy history to chicken
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Shuang Ho Hospital, Taipei medical University
New Taipei City
Ming-Show Hsieh, R.N., 886-2-22490088 ext. 8112, 13508@s.tmu.edu.tw
Chaur-Jong Hu, M.D., 886-2-22490088 ext. 8112, chaurjongh@tmu.edu.tw
About this study
Official title: The Effectiveness of BRAND'S® Essence of Chicken in the Promotion of Resilience and Resistance to Stress-associated Cognitive Inhibition
The purpose of this study is to determine whether BRAND'S® Essence of Chicken are effective in the promotion of resilience and resistance to stress-associated cognitive inhibition.
Read the detailed description
This is a placebo-controlled, randomized, double-blind trial. There will be 100 subjects. Subjects are randomly assigned into either placebo or BRAND'S® Essence of Chicken (BEC), 70cc daily for 2 weeks, group.
Stress test, cognitive function assessment and blood tests will be carried out at Week 0, Week 2, and Week 4 (2 weeks after termination of supplementation).
The primary end-point is the better improvement of cognitive function after supplement with BEC than placebo. The second endpoints include improvement of global health survey and changes of biomarkers related to stress and immunity.
- Conditions
- Stress Associated Cognitive Inhibition, Essence of Chicken, Cognition, Immunity, Metabolism
- Being tested
- Chicken Essence
- Keywords
- Essence of Chicken, stress, cognitive function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chicken EssenceDietary supplement
Also called BRAND'S® Chicken Essence
BRAND'S® Chicken Essence of 70cc daily for 2 weeks Placebo 70 cc daily for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | placebo with the same color, order, taste as BRAND'S® Essence of Chicken , 70cc daily for 2weeks Receives: Dietary Supplement: Chicken Essence |
| Chicken Essence | Experimental | BRAND'S® Chicken Essence 70cc, daily for 2 weeks Receives: Dietary Supplement: Chicken Essence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in cognitive function at week 2 and week 4
Working memory, Episodic memory, Attention
Measured: baseline, week 2, week 4
Secondary outcomes (1)
Change from baseline in biomarkers and and immunity related to stress at week 2 and week 4
ACTH, Cortisol, Melatonin, Glucose, BUN/CRE, GOT/GPT
Measured: baseline, week 2, week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2014 (estimated)
- Study startMar 2014
- Primary completion17 Sep 2019
- Study completion18 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Associated Cognitive InhibitionStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chaur-Jong Hu, M.D., Principal investigator, Neurology, Shuang Ho Hospital, Taipei Meidcal University, New Taipei City, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02166931
- Sponsor's protocol ID
- 201306043
- Status last verified
- Sep 2019
- First submitted
- 9 Jun 2014
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of BRAND'S® Essence of Chicken in the Promotion of Resilience and Resistance to Stress-associated Cognitive Inhibition
- ClinicalTrials.gov ID
- NCT02166931
- Acronym / sponsor ID
- 201306043
- Conditions
- Stress Associated Cognitive Inhibition, Essence of Chicken, Cognition, Immunity, Metabolism
- Keywords
- Essence of Chicken, stress, cognitive function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Study start
- Mar 2014 (actual)
- Primary completion
- 17 Sep 2019 (actual)
- Study completion
- 18 Sep 2019 (estimated)
- First posted
- 18 Jun 2014 (estimated)
- 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.
The purpose of this study is to determine whether BRAND'S® Essence of Chicken are effective in the promotion of resilience and resistance to stress-associated cognitive inhibition.
Detailed description
This is a placebo-controlled, randomized, double-blind trial. There will be 100 subjects. Subjects are randomly assigned into either placebo or BRAND'S® Essence of Chicken (BEC), 70cc daily for 2 weeks, group.
Stress test, cognitive function assessment and blood tests will be carried out at Week 0, Week 2, and Week 4 (2 weeks after termination of supplementation).
The primary end-point is the better improvement of cognitive function after supplement with BEC than placebo. The second endpoints include improvement of global health survey and changes of biomarkers related to stress and immunity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Dietary Supplement: Chicken Essenceplacebo with the same color, order, taste as BRAND'S® Essence of Chicken , 70cc daily for 2weeks |
| Chicken Essence | Experimental | Dietary Supplement: Chicken EssenceBRAND'S® Chicken Essence 70cc, daily for 2 weeks |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged over 20 years,
- mildly stressed with Perceive Stress Scale (PSS) score higher than 25
- All the participants should not require medication for their mood disturbance affected by stress during the trial.
Key exclusion criteria (4 listed)
- history of chronic diseases
- any psychiatric or neurological diseases (e.g. depression)
- other medical illnesses (e.g. stroke, diabetes, other cardiovascular diseases)
- allergy history to chicken
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 |
|---|---|---|
| Chicken EssenceAlso: BRAND'S® Chicken EssenceBRAND'S® Chicken Essence of 70cc daily for 2 weeks Placebo 70 cc daily for 2 weeks | Dietary supplement | Chicken Essence, placebo |
Primary outcome
Change from baseline in cognitive function at week 2 and week 4
Time frame: baseline, week 2, week 4
Working memory, Episodic memory, Attention
1 secondary outcome
Change from baseline in biomarkers and and immunity related to stress at week 2 and week 4
Time frame: baseline, week 2, week 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
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.
Chaur-Jong Hu, M.D. principal investigator
Neurology, Shuang Ho Hospital, Taipei Meidcal University, New Taipei City, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chicken Essence in people with Stress Associated Cognitive Inhibition and Essence of Chicken, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
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 4 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: status not confirmed, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ming-Show Hsieh, R.N. (886-2-22490088 ext. 8112, 13508@s.tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in cognitive function at week 2 and week 4 (time frame: baseline, week 2, week 4). 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 19 Sep 2019.