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The verification study of improvements in psychological stress with intake of black tea extract supplements: a randomized double-blind placebo-controlled crossover trial

Basic Information

Recruitment status	Complete: follow-up complete
Health condition(s) or Problem(s) studied	Healthy adults
Date of first enrollment	2017/03/21
Target sample size	20
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	Duration: 3 weeks Test material: The powder of extracted Uva tea Dose: Take 4 capsules, three times a day (1 capsule for 200 mg) Administrative: Take 4 capsules before each meal *If you forget to take capsules, take them as soon as you remember Duration: 3 weeks Test material: crystalline cellulose and dextrin Dose: Take 4 capsules, three times a day (1 capsule for 200 mg) Administrative: Take 4 capsules before each meal *If you forget to take capsules, take them as soon as you remember

Outcome(s)

Primary Outcome	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	1. salivary alpha-amylase activity 2. cortisol activity

Key inclusion & exclusion criteria

Age minimum	20years-old
Age maximum	Not applicable
Gender	Male and Female
Include criteria
Exclude criteria	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