The verification study of improvements in psychological stress with intake of black tea extract supplements: a randomized double-blind placebo-controlled crossover trial
- Conditions
- Healthy adults
- Registration Number
- JPRN-UMIN000027549
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Not provided
1. Medical history of a malignant tumor, heart failure or myocardial infarction 2. Those who are receiving treatment or having medical history for any of the following chronic diseases: cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or any other chronic diseases 3. Daily use of Food for Specified Health Uses and/or Foods with Functional Claims 4. Those who currently take medicines (include herbal medicines) and/or supplements 5. Those who are allergic to medicines and/or the test food related products 6. Those who have taken caffeine and have become sick 7. Those who are pregnant, breast-feeding, or are expected to become pregnant during the trial period 8. Another clinical test participant within three months before the informed consent form submission 9. Others assessed as inappropriate for this test by the doctor responsible for the test
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method autonomic function test 1. low frequency (LF) 2. high frequency (HF) 3. LF/HF 4.autonomic function age subjective symptoms 1. profile of Mood States 2nd edition (POMS2) Japanese version
- Secondary Outcome Measures
Name Time Method 1. salivary alpha-amylase activity 2. cortisol activity