UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043948 |
|---|---|
| Receipt number | R000050170 |
| Scientific Title | A Study on the Effect of Food Containing Plant Extract on Daytime Problems due to stress, etc. -A Randomized, Double-blind, Placebo-controlled, Cross-over Study- |
| Date of disclosure of the study information | 2021/04/16 |
| Last modified on | 2022/05/27 10:43:02 |
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Basic information
Public title
A Study on the Effect of Food Containing Plant Extract on Daytime Problems due to stress, etc.
-A Randomized, Double-blind, Placebo-controlled, Cross-over Study-
Acronym
A Study on the Effect of Food Containing Plant Extract on Daytime Problems due to stress, etc.
Scientific Title
A Study on the Effect of Food Containing Plant Extract on Daytime Problems due to stress, etc.
-A Randomized, Double-blind, Placebo-controlled, Cross-over Study-
Scientific Title:Acronym
A Study on the Effect of Food Containing Plant Extract on Daytime Problems due to stress, etc.
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effect of food containing plant extract on daytime problems
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sleepiness
Key secondary outcomes
Other questionnaire
Task performance evaluation
Clinical examination items
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Food containing plant extract, 4 weeks consumption. Wash out. Food not containing plant extract, 4 weeks consumption.
Interventions/Control_2
Food not containing plant extract, 4 weeks consumption. Wash out. Food containing plant extract, 4 weeks consumption.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 35 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Healthy Japanese males and females aged 35 to 49 years-old.
2) Subjects who are feeling mental stress or physical fatigue due to the use of PC/smartphone, work, housework, human relationships (including marital relationships), study, etc.
3)Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria
Subjects (who)
1)with irregular sleep hours and sleep habits due to irregular shift work, late night work, etc.
2)have irregular working days or holidays.
3)are judged by doctors to have a high probability of chronic fatigue syndrome.
4)have a probability of depressive symptoms by the screening test(QIDS-J >= 6).
5)contract or are under treatment for serious diseases (e.g., liver disease, kidney disease, digestive disease, heart disease, respiratory disease, endocrine disease, and/or other metabolic disease).
6)contract or have a surgical history of digestive disease affecting digestion and absorption.
7)with sleep apnea syndrome or suspected of sleep apnea syndrome.
8)with a history of and/or current mental illness associated with sleep disorder.
9)have alcohol intake more than approximately 20 g/day of pure alcohol equivalent or a habit of drinking not less than 4 days a week.
10)can't stop drinking from 2 days before each measurement.
11)smoke 20 or more cigarettes a day, or cannot quit smoking during each visit.
12)use supplements, functional foods, or drugs associated with fatigue recovery or lack of sleep.
13)use drugs (such as drugs based on EPA)or supplements (glycine, EPA/DHA, GABA, citric acid, imidazole dipeptides , astaxanthin, coenzyme Q10, etc.) that affects test results.
14)may have allergy to test foods.
15)are pregnant or breast-feeding or planned to become pregnant during the study period.
16)with a history of and/or current drug addiction and/or alcoholism.
17)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.
18)are participating in or willing to participate in other clinical studies.
19)are judged as unsuitable for the current study by the investigator for other reasons.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Iwama |
Organization
Nihonbashi Cardiology Clinic
Division name
Director
Zip code
103-0001
Address
Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
TEL
03-5641-4133
yiwama@well-sleep.jp
Public contact
Name of contact person
| 1st name | Yoshika |
| Middle name | |
| Last name | Komori |
Organization
KSO Corporation
Division name
Sales department
Zip code
105-0023
Address
1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
eigyou27@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
TOYO SHINYAKU Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Nihonbashi Cardiology Clinic
Address
Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
Tel
03-5641-4133
niho-jimucho@well-sleep.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | Month | 16 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000050170
Publication of results
Published
Result
URL related to results and publications
http://www.pieronline.jp/content/article/0386-3603/50040/733
Number of participants that the trial has enrolled
40
Results
Statistically significant difference was confirmed in the primary outcome.
Results date posted
| 2022 | Year | 05 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Males and females aged 35 to 50years old.
Participant flow
Enrolled(n=40)
Completed(n=39)
Analysed(n=29)
Adverse events
No adverse events were observed that be related to test food.
Outcome measures
Sleepiness
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2021 | Year | 04 | Month | 09 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 17 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 04 | Month | 16 | Day |
Last modified on
| 2022 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050170
