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

September 17, 2019 updated by: Taipei Medical University Shuang Ho Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • New Taipei, Taiwan
        • Recruiting
        • Shuang Ho Hospital, Taipei Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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 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
Time Frame: baseline, week 2, 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
Time Frame: baseline, week 2, week 4
ACTH, Cortisol, Melatonin, Glucose, BUN/CRE, GOT/GPT
baseline, week 2, week 4

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in global health survey at week 2 and week 4
Time Frame: baseline, week 2, week 4
chinese version of SF36
baseline, week 2, week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University Shuang Ho Hospital

Investigators

  • Principal Investigator: Chaur-Jong Hu, M.D., Neurology, Shuang Ho Hospital, Taipei Meidcal University, New Taipei City, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2014

Primary Completion (Actual)

September 17, 2019

Study Completion (Anticipated)

September 18, 2019

Study Registration Dates

First Submitted

June 9, 2014

First Submitted That Met QC Criteria

June 16, 2014

First Posted (Estimate)

June 18, 2014

Study Record Updates

Last Update Posted (Actual)

September 19, 2019

Last Update Submitted That Met QC Criteria

September 17, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 201306043

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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