UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045227 |
|---|---|
| Receipt number | R000051669 |
| Scientific Title | A Study on the Effect of Plant-Derived Product on Body Temperature -A Randomized, Double-blind, Placebo-controlled, Cross-over Study- |
| Date of disclosure of the study information | 2021/08/23 |
| Last modified on | 2023/11/29 15:28:26 |
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Basic information
Public title
A Study on the Effect of Plant-Derived Product on Body Temperature
-A Randomized, Double-blind, Placebo-controlled, Cross-over Study-
Acronym
A Study on the Effect of Plant-Derived Product on Body Temperature
Scientific Title
A Study on the Effect of Plant-Derived Product on Body Temperature
-A Randomized, Double-blind, Placebo-controlled, Cross-over Study-
Scientific Title:Acronym
A Study on the Effect of Plant-Derived Product on Body Temperature
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effect of plant-derived product on body temperature
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Core body temperature
Key secondary outcomes
Body surface temperature (only male subjects are measured)
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
Plant-derived products, single ingestion. Wash out. Placebo products, single ingestion.
Interventions/Control_2
Placebo products, single ingestion. Wash out. Plant-derived products, single ingestion.
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 males and females aged 20 to 64 years-old.
2) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria
Subjects (who)
1) contract and/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).
2) have a chronic disease and use medications.
3) have a history and/or a surgical history of digestive disease affecting digestion and absorption.
4) may have allergy to test foods.
5) use medications affecting body temperature.
6) can't stop using supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) affecting body temperature during test periods.
7) are planning to become pregnant after informed consent, pregnant or lactating.
8) are under treatment for or have a history of drug addiction and/or alcoholism.
9) are shift worker and/or midnight-shift worker.
10) had been conducted an operation or beauty treatment on the test spot in the past 6 months.
11) are participating and/or are planning to participate in other clinical studies that affect this study after informed consent.
12) are judged unsuitable for the current study by the investigator for other reasons.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Saeko |
| Middle name | |
| Last name | Isaka |
Organization
TOYO SHINYAKU Co., Ltd.
Division name
Clinical and analytical research center
Zip code
841-0005
Address
7-28 Yayoigaoka, Tosu-Shi, Saga, Japan
TEL
0942-81-3555
isakas@toyoshinyaku.co.jp
Public contact
Name of contact person
| 1st name | Nobutaka |
| Middle name | |
| Last name | Kusaba |
Organization
TOYO SHINYAKU Co., Ltd.
Division name
Clinical and analytical research center
Zip code
841-0005
Address
7-28 Yayoigaoka, Tosu-Shi, Saga, Japan
TEL
0942-81-3555
Homepage URL
gakujutsu@toyoshinyaku.co.jp
Sponsor or person
Institute
TOYO SHINYAKU Co., Ltd.
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
Miura Clinic, Medical Corporation Kanonkai IRB
Address
9F Higashitenma building, 1-7-17 Higashitenma, Kita-ku, Osaka, Osaka, Japan
Tel
06-6135-5200
mterashima@miura-cl.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 | 08 | Month | 23 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000051669
Publication of results
Published
Result
URL related to results and publications
http://www.pieronline.jp/content/article/0386-3603/50040/687
Number of participants that the trial has enrolled
25
Results
Statistically significant difference was confirmed in the primary outcome.
Results date posted
| 2022 | Year | 06 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Males and females aged 20 to 64 years old.
Participant flow
Enrolled(n=25)
Completed(n=23)
Analysed(n=23)
Adverse events
No adverse events were observed that be related to test food.
Outcome measures
Core body temperature
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 24 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 30 | 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 | 08 | Month | 23 | Day |
Last modified on
| 2023 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051669
| Research Plan | |
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| 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 |
