Unique ID issued by UMIN | UMIN000029582 |
---|---|
Receipt number | R000033794 |
Scientific Title | The verification study of improvements in psychological stress: a randomized double-blind, parallel-group, placebo-controlled trial |
Date of disclosure of the study information | 2017/10/16 |
Last modified on | 2018/07/19 09:21:04 |
The verification study of improvements in psychological stress: a randomized double-blind, parallel-group, placebo-controlled trial
The verification study of improvements in psychological stress
The verification study of improvements in psychological stress: a randomized double-blind, parallel-group, placebo-controlled trial
The verification study of improvements in psychological stress
Japan |
Healthy Japanese adults
Not applicable | Adult |
Others
NO
To verify the improvement of psychological stress with intake of the test food
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
Autonomic function
* Assess at screening and examination before consuming and at 4 and 8 weeks after consuming. Perform the test before and after psychological stress load.
1. Salivary amylase activity
2. Salivary cortisol activity
3. Pepsinogen I (PGI)
4. Pepsinogen II (PGII)
5. PGI/PGII
6. Profile of Mood States 2nd Edition (POMS2) Japanese version
7. Izumo Scale
8. Original questionnaires
8a. Visual Analogue Scale (VAS)
8b. Likert scale
*1-6,8a Assess at screening and examination before consuming and at 4 and 8 weeks after consuming. Perform these assessments before and after psychological stress load.
*7,8b Assess at screening and examination before consuming and at 4 and 8 weeks after consuming. Perform the assessment before psychological stress load.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
2
Treatment
Food |
Duration: 8 weeks
Test material: Active capsule
Dose: Take 3 capsules per day
Administration: Take a capsule after breakfast, lunch, and dinner.
* If you cannot eat either breakfast or lunch, take 2 capsules of the test food at once after next meal within the day. If you cannot eat dinner, take the test food in the evening.
* If you forget to take the capsule, take it as soon as you remember within the day.
Duration: 8 weeks
Test material: Placebo capsule
Dose: Take 3 capsules per day
Administration: Take a capsule after breakfast, lunch, and dinner.
* If you cannot eat breakfast or lunch, take 2 capsules of the test food at once after next meal within the day. If you cannot eat dinner, take the test food in the evening.
* If you forget to take the capsule, take it as soon as you remember within the day.
20 | years-old | <= |
Not applicable |
Male and Female
1. Healthy Japanese adults
2. Subjects experiencing stress in daily
3. Subjects whose the result of the Helicobacter pylori antibody test is negative at screening and examination before ingestion and are judged as eligible to participate in the study by the principal investigator
4. Among the subjects who met 3rd inclusion
criteria, subjects whose LF/HF ratio at autonomic function test is relatively high
1. At least one previous medical history or under the treatment of malignant tumor, heart failure or myocardial infarction
2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or other chronic diseases
3. Subjects who use or take "Foods for Specified Health Uses" and "Foods with Functional Claims" in daily
4. Currently taking medicines (include herbal medicines) and supplements
5. Subjects who are allergic to medicines and/or the test food related products
6. Subjects who are pregnant, breast-feeding, and plan to become pregnant
7. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial
8. Subjects who are judged as ineligible to participate in the study by the principal investigator
9. Subjects who have been diagnosed with Helicobacter pylori infection
40
1st name | |
Middle name | |
Last name | Kazuo YAMAMOTO |
ORTHOMEDICO Inc.
CEO
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
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, Japan.
03-3818-0610
nao@orthomedico.jp
ORTHOMEDICO Inc.
MITSUBISHI-CHEMICAL FOODS CORPORATION
Profit organization
Medical Corporation Seishinkai, Takara Clinic
NO
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
2017 | Year | 10 | Month | 16 | Day |
Unpublished
Completed
2017 | Year | 10 | Month | 11 | Day |
2017 | Year | 10 | Month | 17 | Day |
2017 | Year | 10 | Month | 16 | Day |
2018 | Year | 07 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033794
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