Unique ID issued by UMIN | UMIN000027549 |
---|---|
Receipt number | R000028730 |
Scientific Title | The verification study of improvements in psychological stress with intake of black tea extract supplements: a randomized double-blind placebo-controlled crossover trial |
Date of disclosure of the study information | 2017/09/01 |
Last modified on | 2017/09/25 13:06:58 |
The verification study of improvements in psychological stress with intake of black tea extract supplements: a randomized double-blind placebo-controlled crossover trial
The verification study of improvements in psychological stress with intake of black tea extract supplements
The verification study of improvements in psychological stress with intake of black tea extract supplements: a randomized double-blind placebo-controlled crossover trial
The verification study of improvements in psychological stress with intake of black tea extract supplements
Japan |
Healthy adults
Not applicable | Adult |
Others
NO
To verify study of improvements in psychological stress with intake of extracted Japanese Uva tea supplements
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
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
1. salivary alpha-amylase activity
2. cortisol activity
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Food |
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
20 | years-old | <= |
Not applicable |
Male and Female
1. Those who feel stress in daily
2. Healthy Japanese adults
3. Those who are considered to appropriate for the study by the physician
4. Those who have relatively high difference between age of autonomic nervous function and their actual age
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
20
1st name | |
Middle name | |
Last name | Kazuo YAMAMOTO |
ORTHOMEDICO Inc.
CEO
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
03-3818-0610
kazu@orthomedico.jp
1st name | |
Middle name | |
Last name | Naoko SUZUKI |
ORTHOMEDICO Inc.
R&D Department
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
03-3818-0610
nao@orthomedico.jp
ORTHOMEDICO Inc.
ORTHOMEDICO Inc.
Self funding
Seishin-kai Medical Association Inc, Takara Medical Clinic
1. WASEDA University Research Organization for Nano & Life Innovation
2. Mitsui Sugar Co., Ltd.
NO
医療法人社団 盛心会 タカラクリニック
Seishin-kai Medical Association Inc, Takara Medical Clinic
2017 | Year | 09 | Month | 01 | Day |
Unpublished
Completed
2016 | Year | 11 | Month | 15 | Day |
2017 | Year | 03 | Month | 21 | Day |
2017 | Year | 05 | Month | 30 | Day |
2017 | Year | 09 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028730
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |