Unique ID issued by UMIN | UMIN000051050 |
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Receipt number | R000058199 |
Scientific Title | A Study on the Effect of Food Containing Plant Extract on Mood -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study- |
Date of disclosure of the study information | 2023/05/14 |
Last modified on | 2023/05/12 13:49:15 |
A Study on the Effect of Food Containing Plant Extract on Mood
-A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
A Study on the Effect of Food Containing Plant Extract on Mood
A Study on the Effect of Food Containing Plant Extract on Mood
-A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
A Study on the Effect of Food Containing Plant Extract on Mood
Japan |
No
Adult |
Others
NO
To confirm the effect of food containing plant extract on mood
Efficacy
Questionnaire on overall mood
Other questionnaire
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Treatment
Food |
Food containing plant extract, 4 weeks consumption
Food not containing plant extract, 4 weeks consumption
30 | years-old | <= |
50 | years-old | > |
Male and Female
(1)Healthy males and females aged 30 to 49 years old.
(2)Subjects who feel decreasing vitality in daily life.
(3)Subjects who can make self-judgment and are voluntarily giving written informed consent.
Subjects (who)
1)have a probability of idiopathic chronic fatigue or chronic fatigue syndrome based on self-report.
2)have a chronic disease and regularly use medications.
3)have a probability of depression by CES-D scores, medical interview, etc.
4)with a history of and/or current sleep disorders.
5)contract or are under treatment for serious diseases (eg, liver disease, kidney disease, digestive disease, heart disease, respiratory disease, endocrine disease, thyroid disease, adrenal disease and/or metabolic disease).
6)use supplements, functional foods, or drugs associated with fatigue recovery or lack of sleep.
7)have a history and/or a surgical history of digestive disease affecting digestion and absorption.
8)may have allergy to test foods.
9)are pregnant or planning to become pregnant or breastfeed during the study period.
10)have excessive alcohol intake more than 20 g/day of pure alcohol equivalent for more than 4 days a week.
11)can't stop drinking from 2 days before each measurement.
12)are under treatment for or have a history of drug addiction and/or alcoholism.
13)smoke 20 or more cigarettes a day, or cannot quit smoking during from waking to inspection completed.
14)are shiftworker, midnight worker and/or physical labor.
15)have regular hard exercise.
16)have donated over 200 mL of blood and/or blood components within the last one month prior to the current study or over 400 mL of blood and/or blood components within the last three months prior to the current study.
17)are planning to participate and/or had participated in other clinical studies within the last one month prior to the current study.
18)are judged as unsuitable for the current study by the investigator for other reasons.
70
1st name | Masahiko |
Middle name | |
Last name | Tokushima |
Maebashi North Hospital
Director
371-0054
692 Shimohosoi-machi,Maebashi-shi,Gunma
027-235-3333
sagawa@mc-connect.co.jp
1st name | Yoshika |
Middle name | |
Last name | Komori |
KSO Corporation
Sales department
105-0023
1-9-7 Shibaura, Minato-ku, Tokyo
03-3452-7733
eigyou27@kso.co.jp
KSO Corporation
TOYO SHINYAKU Co., Ltd.
Profit organization
Ethical Committee of Kobuna Orthopedics Clinic
5-656-17 Joto-machi, Maebashi-shi, Gunma
027-212-5608
sagawa@mc-connect.co.jp
NO
2023 | Year | 05 | Month | 14 | Day |
Unpublished
Preinitiation
2023 | Year | 04 | Month | 13 | Day |
2023 | Year | 05 | Month | 15 | Day |
2023 | Year | 08 | Month | 31 | Day |
2023 | Year | 05 | Month | 12 | Day |
2023 | Year | 05 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058199
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