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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0003101

Enrollment

Registered

2018-08-17

Start date

2018-08-03

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : Mixtures of creatine and taurine or placebo 1 pack (4g) per day, once a day for 8 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Countries

Korea, Republic of

Contacts

Public ContactJungyoon Kim

Ewha Womans University

jungyoon.kimm@gmail.com+82-2-3277-6555

Outcome results