UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044186 |
|---|---|
| Receipt number | R000050439 |
| Scientific Title | A Study on the Effect of Food Containing Plant Extract on QOL -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study- |
| Date of disclosure of the study information | 2021/05/14 |
| Last modified on | 2022/03/01 11:21:50 |
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Basic information
Public title
A Study on the Effect of Food Containing Plant Extract on QOL
-A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Acronym
A Study on the Effect of Food Containing Plant Extract on QOL
Scientific Title
A Study on the Effect of Food Containing Plant Extract on QOL
-A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Scientific Title:Acronym
A Study on the Effect of Food Containing Plant Extract on QOL
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 QOL
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
QOL questionnaire
Key secondary outcomes
complexion
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Foods containing plant extract, 4 weeks consumption
Interventions/Control_2
Foods not 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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Healthy Japanese males and females aged 20 to 64 years-old.
2)Subjects who tend to feel tired easily in daily life.
3)Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria
Subjects (who)
1)are judged by doctors to have a high probability of chronic fatigue syndrome.
2)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).
3)have a chronic disease and use medications.
4)contract or have a surgical history of digestive disease affecting digestion and absorption.
5)may have allergy to test foods.
6)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.
7)can't stop drinking from 2 days before each measurement.
8) smoke 10 or more cigarettes a day, or cannot quit smoking during from waking to inspection completed.
9)use drugs, supplements, or functional foods associated with fatigue recovery.
10)are shiftworker, midnight worker and/or hard worker.
11)have regular hard exercise.
12) are pregnant or breast-feeding or planned to become pregnant during the study period.
13) 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.
14)are participating in or willing to participate in other clinical studies.
15)are judged as unsuitable for the current study by the investigator for other reasons.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kayoko |
| Middle name | |
| Last name | Numano |
Organization
Ebisu Ray Clinic, Shinkoukai Medical Corporation
Division name
Dermatology
Zip code
150-0013
Address
1-11-2 Ebisu, Shibuya-ku, Tokyo
TEL
03-6277-3917
kaco@yahoo.co.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
General Incorporated Association Clinical Research Review Center
Address
2972-8-603 Ishikawacho, Hachiouji-shi, Tokyo
Tel
090-3547-6398
crrctakashima@kpd.biglobe.ne.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 | 05 | Month | 14 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000050439
Publication of results
Published
Result
URL related to results and publications
http://www.pieronline.jp/content/article/0386-3603/49120/2127
Number of participants that the trial has enrolled
50
Results
Statistically significant difference was confirmed in the primary outcome.
Results date posted
| 2022 | Year | 03 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Males and females aged 20 to 64years old.
Participant flow
Enrolled(n=50)
Completed(n=50)
Analysed(n=35)
Adverse events
No adverse events were observed that be related to test food.
Outcome measures
QOL questionnaire
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2021 | Year | 04 | Month | 12 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 04 | 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 | 05 | Month | 12 | Day |
Last modified on
| 2022 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050439
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
