Efficacy and Safety of Creatine/Taurine for Relieving Stress and Tensio

Not Applicable

Recruiting

• Conditions: Not Applicable

• Registration Number: KCT0003101
• Lead Sponsor: Ewha Womans University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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)

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline stress/tension symptoms at 4 weeks/8 weeks assessed by the Visual Analog Scale;Change from baseline depressive/anxiety symptom levels at 4 weeks/8 weeks assessed by the Hamilton Depression Rating Scale;Change from baseline depressive/anxiety symptom levels at 4 weeks/8 weeks assessed by the Hamilton Anxiety Rating Scale;Change from baseline depressive symptom levels at 4 weeks/8 weeks assessed by the Beck Depression Inventory;Change from baseline anxiety symptom levels at 4 weeks/8 weeks assessed by the Beck Anxiety Inventory;Change from baseline stress symptoms at 4 weeks/8 weeks assessed by the Korean-translated Brief Encounter Psychosocial Instrument;Change from baseline stress symptoms at 4 weeks/8 weeks assessed by the Cognitive Stress Response Scale;Change from baseline stress symptoms at 4 weeks/8 weeks assessed by the Perceived Stress Scale

Secondary Outcome Measures

Name	Time	Method
Change from baseline stress symptoms and tension at 8 weeks assessed by the Skin Conductance Response;Change from baseline cognitive functions at 8 weeks assessed by the neuropsychological test battery;Change from baseline brain structure, function, and metabolism at 8 weeks assessed by computational analysis of magnetic resonance imaging data