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Trial record 5 of 245 for:    essential oil

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE June 9, 2014
First Posted Date  ICMJE June 18, 2014
Last Update Posted Date September 19, 2019
Actual Study Start Date  ICMJE March 2014
Actual Primary Completion Date September 17, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2014)
Change from baseline in cognitive function at week 2 and week 4 [ Time Frame: baseline, week 2, week 4 ]
Working memory, Episodic memory, Attention
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02166931 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2014)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 16, 2014)
Change from baseline in global health survey at week 2 and week 4 [ Time Frame: baseline, week 2, week 4 ]
chinese version of SF36
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE BRAND'S® Essence of Chicken in the Promotion of Resilience and Resistance to Stress-associated Cognitive Inhibition
Official Title  ICMJE The Effectiveness of BRAND'S® Essence of Chicken in the Promotion of Resilience and Resistance to Stress-associated Cognitive Inhibition
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Stress Associated Cognitive Inhibition
  • Essence of Chicken
  • Cognition
  • Immunity
  • Metabolism
Intervention  ICMJE 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
Study Arms  ICMJE
  • Placebo Comparator: placebo
    placebo with the same color, order, taste as BRAND'S® Essence of Chicken , 70cc daily for 2weeks
    Intervention: Dietary Supplement: Chicken Essence
  • Experimental: Chicken Essence
    BRAND'S® Chicken Essence 70cc, daily for 2 weeks
    Intervention: Dietary Supplement: Chicken Essence
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 16, 2014)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 18, 2019
Actual Primary Completion Date September 17, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
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
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02166931
Other Study ID Numbers  ICMJE 201306043
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Taipei Medical University Shuang Ho Hospital
Study Sponsor  ICMJE Taipei Medical University Shuang Ho Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chaur-Jong Hu, M.D. Neurology, Shuang Ho Hospital, Taipei Meidcal University, New Taipei City, Taiwan
PRS Account Taipei Medical University Shuang Ho Hospital
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP