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Efficacy and Safety of Creatine/Taurine for Relieving Stress and Tension: A Prospective Randomized Double-Blind Placebo-Controlled Clinical Trial

Status Approved

First Submitted Date

2018/07/26
Registered Date

2018/08/17
Last Updated Date

2018/08/28

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0003101
Unique Protocol ID	160-16
Public/Brief Title	Efficacy and Safety of Creatine/Taurine for Relieving Stress and Tension
Scientific Title	Efficacy and Safety of Creatine/Taurine for Relieving Stress and Tension: A Prospective Randomized Double-Blind Placebo-Controlled Clinical Trial
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	160-16
Approval Date	2018-07-05
Institutional Review Board Name	Ewha Womans University Institutional Review Board
Institutional Review Board Address	52, Ewhayeodae-gil, Seodaemun-gu, Seoul
Institutional Review Board Telephone	02-3277-7152
Data Monitoring Committee

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Jungyoon Kim
Title	Assistant professor
Telephone	+82-2-3277-6555
Affiliation	Ewha Womens University
Address	52, Ewhayeodae-gil, Seodaemun-gu, Seoul, Republic of Korea
Contact Person for Public Queries
Name	Jungyoon Kim
Title	Assistant professor
Telephone	+82-2-3277-6555
Affiliation	Ewha Womens University
Address	52, Ewhayeodae-gil, Seodaemun-gu, Seoul, Republic of Korea
Contact Person for Updating Information
Name	Jungyoon Kim
Title	Assistant professor
Telephone	+82-2-3277-6555
Affiliation	Ewha Womens University
Address	52, Ewhayeodae-gil, Seodaemun-gu, Seoul, Republic of Korea

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Recruiting
Date of First Enrollment	2018-08-03 Anticipated
Target Number of Participant	80
Primary Completion Date
Study Completion Date
Name of Study	Ewha Womens University
Recruitment Status	Recruiting
Date of First Enrollment	2018-08-03 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	National Fire Agency
Organization Type	Government
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Ewha Womens University
Organization Type	University

7. Study Summary

Study Summary Information
Lay Summary	This study aims to investigate the efficacy and safety of the mixtures of creatine and taurine for relieving stress and tension.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Treatment
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Double
Blinded Subject	Subject, Investigator
Allocation	RCT
Intervention Type	Dietary Supplement
Intervention Description	Mixtures of creatine and taurine or placebo 1 pack (4g) per day, once a day for 8 weeks.
Number of Arms	2
Arm 1	Arm Label Creatine/Taurine
	Target Number of Participant 40
	Arm Type Experimental
	Arm Description Mixtures of creatine and taurine 1 pack (4g) per day, once a day for 8 weeks.
Arm 2	Arm Label Placebo
	Target Number of Participant 40
	Arm Type Placebo comparator
	Arm Description Placebo 1 pack (4g) per day, once a day for 8 weeks.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (Z00-Z99)Factors influencing health status and contact with health services (Z73.3)Problems related to stress, NEC
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 19Year~60Year
	Description - Healthy volunteers who are between the ages of 19 and 60 - The case of which interview of a psychiatrist and questionnaire(VAS, Visual Analog Scale) indicate that there are current stress and tension symptoms (VAS 50％ or more)
Exclusion Criteria	- Diagnosed with any major medical or neurological disorders assessed during medical history taking, physical examination or experimental tests - Diagnosed with any axis 1 psychiatric disorders (depressive disorder, bipolar disorder, alcohol dependence, schizophrenia) evaluated with a structured instrument - A history of traumatic brain injury with loss of consciousness or conversion - Had experienced side effects after consumption of any product containing creatine and/or taurine - Planning for pregnancy during the period of study participation, currently pregnant or breastfeeding - Had taken psychotropic drugs within the past 2 months before study participation - Had taken a dietary supplement for relieving stress and tension(lactium, L-theanine, Ashwagandha extract, etc.) within the past 2 months before study participation - Participated in another clinical trial within the past 1 months before screening - Any contraindications to MRI (i.e., claustrophobia, metallic foreign devices in the body)
Healthy Volunteers	Yes

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	/Safety/Efficacy
Outcome	Change from baseline stress/tension symptoms at 4 weeks/8 weeks assessed by the Visual Analog Scale
Timepoint	Baseline, week 4 and week 8
Primary Outcome(s) 2
Outcome	Change from baseline depressive/anxiety symptom levels at 4 weeks/8 weeks assessed by the Hamilton Depression Rating Scale
Timepoint	Baseline, week 4 and week 8
Primary Outcome(s) 3
Outcome	Change from baseline depressive/anxiety symptom levels at 4 weeks/8 weeks assessed by the Hamilton Anxiety Rating Scale
Timepoint	Baseline, week 4 and week 8
Primary Outcome(s) 4
Outcome	Change from baseline depressive symptom levels at 4 weeks/8 weeks assessed by the Beck Depression Inventory
Timepoint	Baseline, week 4 and week 8
Primary Outcome(s) 5
Outcome	Change from baseline anxiety symptom levels at 4 weeks/8 weeks assessed by the Beck Anxiety Inventory
Timepoint	Baseline, week 4 and week 8
Primary Outcome(s) 6
Outcome	Change from baseline stress symptoms at 4 weeks/8 weeks assessed by the Korean-translated Brief Encounter Psychosocial Instrument
Timepoint	Baseline, week 4 and week 8
Primary Outcome(s) 7
Outcome	Change from baseline stress symptoms at 4 weeks/8 weeks assessed by the Cognitive Stress Response Scale
Timepoint	Baseline, week 4 and week 8
Primary Outcome(s) 8
Outcome	Change from baseline stress symptoms at 4 weeks/8 weeks assessed by the Perceived Stress Scale
Timepoint	Baseline, week 4 and week 8
Secondary Outcome(s) 1
Outcome	Change from baseline stress symptoms and tension at 8 weeks assessed by the Skin Conductance Response
Timepoint	Baseline and week 8
Secondary Outcome(s) 2
Outcome	Change from baseline cognitive functions at 8 weeks assessed by the neuropsychological test battery
Timepoint	Baseline and week 8
Secondary Outcome(s) 3
Outcome	Change from baseline brain structure, function, and metabolism at 8 weeks assessed by computational analysis of magnetic resonance imaging data
Timepoint	Baseline and week 8

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	Not provided at time of Registration

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