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Trial record 3 of 308 for:    Recruiting, Not yet recruiting, Available Studies | Inhibition

BRAND'S® Essence of Chicken in the Promotion of Resilience and Resistance to Stress-associated Cognitive Inhibition

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ClinicalTrials.gov Identifier: NCT02166931
Recruitment Status : Recruiting
First Posted : June 18, 2014
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Taipei Medical University Shuang Ho Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Stress Associated Cognitive Inhibition Essence of Chicken Cognition Immunity Metabolism Dietary Supplement: Chicken Essence Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effectiveness of BRAND'S® Essence of Chicken in the Promotion of Resilience and Resistance to Stress-associated Cognitive Inhibition
Actual Study Start Date : March 2014
Actual Primary Completion Date : September 17, 2019
Estimated Study Completion Date : September 18, 2019

Arm Intervention/treatment
Placebo Comparator: placebo
placebo with the same color, order, taste as BRAND'S® Essence of Chicken , 70cc daily for 2weeks
Dietary Supplement: Chicken Essence
BRAND'S® Chicken Essence of 70cc daily for 2 weeks Placebo 70 cc daily for 2 weeks
Other Name: BRAND'S® Chicken Essence

Experimental: Chicken Essence
BRAND'S® Chicken Essence 70cc, daily for 2 weeks
Dietary Supplement: Chicken Essence
BRAND'S® Chicken Essence of 70cc daily for 2 weeks Placebo 70 cc daily for 2 weeks
Other Name: BRAND'S® Chicken Essence




Primary Outcome Measures :
  1. Change from baseline in cognitive function at week 2 and week 4 [ Time Frame: baseline, week 2, week 4 ]
    Working memory, Episodic memory, Attention


Secondary Outcome Measures :
  1. Change from baseline in biomarkers and and immunity related to stress at week 2 and week 4 [ Time Frame: baseline, week 2, week 4 ]
    ACTH, Cortisol, Melatonin, Glucose, BUN/CRE, GOT/GPT


Other Outcome Measures:
  1. Change from baseline in global health survey at week 2 and week 4 [ Time Frame: baseline, week 2, week 4 ]
    chinese version of SF36



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02166931


Contacts
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Contact: Ming-Show Hsieh, R.N. 886-2-22490088 ext 8112 13508@s.tmu.edu.tw
Contact: Chaur-Jong Hu, M.D. 886-2-22490088 ext 8112 chaurjongh@tmu.edu.tw

Locations
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Taiwan
Shuang Ho Hospital, Taipei medical University Recruiting
New Taipei, Taiwan
Contact: Ming-Show Hsieh, R.N.    886-2-22490088 ext 8112    13508@s.tmu.edu.tw   
Contact: Chaur-Jong Hu, M.D.    886-2-22490088 ext 8112    chaurjongh@tmu.edu.tw   
Principal Investigator: Chaur-Jong Hu, M.D.         
Sponsors and Collaborators
Taipei Medical University Shuang Ho Hospital
Investigators
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Principal Investigator: Chaur-Jong Hu, M.D. Neurology, Shuang Ho Hospital, Taipei Meidcal University, New Taipei City, Taiwan

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Responsible Party: Taipei Medical University Shuang Ho Hospital
ClinicalTrials.gov Identifier: NCT02166931     History of Changes
Other Study ID Numbers: 201306043
First Posted: June 18, 2014    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Keywords provided by Taipei Medical University Shuang Ho Hospital:
Essence of Chicken
stress
cognitive function