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

Study Overview
=================
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.

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

Conditions
-----------------
Stress Associated Cognitive Inhibition, Essence of Chicken, Cognition, Immunity, Metabolism

Intervention / Treatment
-----------------
* Dietary Supplement: Chicken Essence


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>placebo with the same color, order, taste as BRAND'S® Essence of Chicken , 70cc daily for 2weeks | Dietary Supplement: Chicken Essence<br>* BRAND'S® Chicken Essence of 70cc daily for 2 weeks Placebo 70 cc daily for 2 weeks<br>* Other names: BRAND'S® Chicken Essence;|
| Experimental: Chicken Essence<br>BRAND'S® Chicken Essence 70cc, daily for 2 weeks | Dietary Supplement: Chicken Essence<br>* BRAND'S® Chicken Essence of 70cc daily for 2 weeks Placebo 70 cc daily for 2 weeks<br>* Other names: BRAND'S® Chicken Essence;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in cognitive function at week 2 and week 4 | Working memory, Episodic memory, Attention | baseline, week 2, week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Essence of Chicken, stress, cognitive function