Unique ID issued by UMIN | UMIN000049989 |
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Receipt number | R000056935 |
Scientific Title | A study of the effects of test food on stress, sleep quality and fatigue -A randomized, double-blind, placebo-controlled, parallel study |
Date of disclosure of the study information | 2023/01/08 |
Last modified on | 2023/07/09 10:43:18 |
A study of the effects of test food on stress, sleep quality and fatigue -A randomized, double-blind, placebo-controlled, parallel study
A study of the effects of test food on stress, sleep quality and fatigue
A study of the effects of test food on stress, sleep quality and fatigue -A randomized, double-blind, placebo-controlled, parallel study
A study of the effects of test food on stress, sleep quality and fatigue
Japan |
Healthy subjects who are stressed and have problems such as sleep quality or fatigue (Non-chronic, non-illness)
Adult |
Others
NO
To identify the effects of test food on stress, sleep quality and fatigue
Safety
Evaluation of stress, sleep quality and fatigue by SRS-18, POMS2, Izumo Scale, OSA-MA, VAS at 0 week and at 8 weeks
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
YES
2
Treatment
Food |
Oral intake of the test foods (1 drink in a day for 8 weeks)
Oral intake of the placebo foods (1 drink in a day for 8 weeks)
18 | years-old | <= |
65 | years-old | > |
Male and Female
1) Healthy subjects who are stressed and have problems such as sleep quality or fatigue (Non-chronic, non-illness)
2) Healthy adults aged 40 to 75 years old.
3) Gender: No preference
4) Subjects without smoking habits
5) Subjects who do not have a habit of taking a meal containing test foods
6)Subjects who do not regularly use supplements and health foods
7) Subjects who do not suffer from lifestyle diseases (high blood pressure, diabetes etc.), rheumatism, liver disorders, renal disorders, other chronic diseases
8) Subjects who have no history of treatment of malignant tumor, heart failure, myocardial infarction
9) Subjects who have no history of allergy to test foods / medicines
10) Subjects who do not take medication for Outpatient treatment
11) Subjects giving written informed consent
1) Females who are pregnant or lactating, and females who could become pregnant or lactating during test period
2) Subjects who are participating the other clinical tests. Subjects who participated within 3-month prior to the current study
3) Subjects who do not comply with instructions from the doctor or medical staff
4) Others who have been determined ineligible by investigator
52
1st name | Naotaka |
Middle name | |
Last name | Hashiya |
Kanyukai clinic
Head
553-0004
2-12-24 Tamagawa Fukushima-ku,Osaka-shi,Osaka,553-0004,Japan
06-6444-7788
hashiya@carna-medsalon.jp
1st name | Taisuke |
Middle name | |
Last name | Fukaya |
Tashikani Plus Co., Ltd
CEO
530-0041
6F 2-2-27 Tenjinbashi Kita-ku,Osaka-shi,Osaka,530-0041,Japan
06-6352-6622
fukaya@tashikani.jp
Kanyukai clinic
non-disclosure
Profit organization
Japan Food Evidence Association
7F 2-2-27 Tenjinbashi,Kita-ku,Osaka,530-0041,Japan
06-6352-6622
info@food-evidence.jp
NO
2023 | Year | 01 | Month | 08 | Day |
Unpublished
Completed
2022 | Year | 12 | Month | 28 | Day |
2022 | Year | 12 | Month | 28 | Day |
2023 | Year | 01 | Month | 11 | Day |
2023 | Year | 05 | Month | 31 | Day |
2023 | Year | 01 | Month | 08 | Day |
2023 | Year | 07 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056935
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