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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02166931
Other study ID # 201306043
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 2014
Est. completion date September 18, 2019

Study information

Verified date September 2019
Source Taipei Medical University Shuang Ho Hospital
Contact Ming-Show Hsieh, R.N.
Phone 886-2-22490088
Email 13508@s.tmu.edu.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date September 18, 2019
Est. primary completion date September 17, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Taiwan Shuang Ho Hospital, Taipei medical University New Taipei

Sponsors (1)

Lead Sponsor Collaborator
Taipei Medical University Shuang Ho Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Other Change from baseline in global health survey at week 2 and week 4 chinese version of SF36 baseline, week 2, week 4
Primary Change from baseline in cognitive function at week 2 and week 4 Working memory, Episodic memory, Attention baseline, week 2, week 4
Secondary 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 baseline, week 2, week 4
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