Unique ID issued by UMIN | UMIN000043898 |
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Receipt number | R000050063 |
Scientific Title | Study on stress relief effects of test food intake. |
Date of disclosure of the study information | 2021/04/18 |
Last modified on | 2021/12/13 15:53:17 |
Study on stress relief effects of test food intake.
Study on stress relief effects of test food intake.
Study on stress relief effects of test food intake.
Study on stress relief effects of test food intake.
Japan |
Healthy human
Adult |
Others
NO
Evaluate of the effect on stress when healthy adults who are prone to stress take test food for 4 week.
Efficacy
alpha-amylase in saliva
Cortisol in saliva, Mood States [The Profile of Mood States , POMS] , Quality of sleep [OSA sleep inventory MA version]
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
Take a test food for 4 week (1tablet / day).
Take a placebo food for 4 week (1tablet / day).
20 | years-old | <= |
60 | years-old | >= |
Male and Female
1.Individual having screening test result and questionnaire result judged to be appropriate for this study by investigator.
1. Diabetes mellitus under medical treatment.
2. Individual having severe diseases (e.g. liver, kidney, heart, blood diseases, and infections requiring the notification)
3. Individual received gastrectomy, enterectomy, and gastro-intestinal diseases, judged to be inappropriate for this study.
4.Pregnant, women having the possibility, and lactating women.
5. Participants in order clinical trial.
6.Individuals with food allergies.
7.Individual who regularly use health foods and supplements that affect stress and sleep.
8.Smoker.
9.Individual who takes a lot of alcohol .(Pure alcohol intake 60g or more / day)
10.Individuals working at night.
11.Individual who take a large amount of beverage high in caffeine on a daily basis. (coffee 700mL or more/ day)
12.Individual have mental illness(depression, etc.) or sleeping disorder or have a history of psychiatry in the past.
13.Individual have major changes in the home and work environment or expected stressful situation.
14.Individual rejected participating in this study by chief investigator.
18
1st name | Kenichi |
Middle name | |
Last name | Watanabe |
Niigata Bio-Research Park, Inc
Advisor
9560841
316-2, Higashijima, Akiha-ku, Niigata, 956-0841, Japan
0250-25-1196
wataken@med.niigata-u.ac.jp
1st name | Hiroshi |
Middle name | |
Last name | Goto |
Niigata Bio-Research Park, Inc
Business promotion division
9560841
316-2, Higashijima, Akiha-ku, Niigata, 956-0841, Japan
0250-25-1196
goto@nbrp.co.jp
Niigata Bio-Research Park, Inc
Bourbon Corporation
Profit organization
NBRC Research Ethics Review Committee
316-2, Higashijima, Akiha-uk, Niigata, 956-0841, Japan
0250-25-1196
nbrp-food-navi@nbrp.co.jp
NO
2021 | Year | 04 | Month | 18 | Day |
Unpublished
Completed
2021 | Year | 03 | Month | 01 | Day |
2021 | Year | 03 | Month | 29 | Day |
2021 | Year | 04 | Month | 18 | Day |
2021 | Year | 08 | Month | 20 | Day |
2021 | Year | 04 | Month | 12 | Day |
2021 | Year | 12 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050063
Research Plan | |
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