UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044795 |
|---|---|
| Receipt number | R000051160 |
| Scientific Title | Effects of repeated ingestion of plant-derived ingredient on cold constitution of body |
| Date of disclosure of the study information | 2021/07/08 |
| Last modified on | 2024/09/13 10:48:09 |
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Basic information
Public title
Effects of repeated ingestion of plant-derived ingredient on cold constitution of body
Acronym
Effects of repeated ingestion of plant-derived ingredient
Scientific Title
Effects of repeated ingestion of plant-derived ingredient on cold constitution of body
Scientific Title:Acronym
Effects of repeated ingestion of plant-derived ingredient
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate effects of repeated consumption of a plant-derived ingredient for 1 weeks on cold constitution of body in young women
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Finger skin temparature after load of cold water
Key secondary outcomes
Finger blood flow after load of cold water
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
Repeated intake control food, once in a day for 1 week, after wash out for 2 weeks, repeated intake test food, once in a day for 1 week.
Interventions/Control_2
Repeated intake test food, once in a day for 1 weeks, after wash out for 2 weeks, repeated intake control food, once in a day for 1 week.
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
| 29 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Healthy female adults aged from 20 y to 29 y
2. Subjects who agree to participate in this study with a written informed consent after receiving sufficient explanation relating to this study
Key exclusion criteria
1. Subjects who have respiratory, gastrointestinal, hepatic/gallbladder/pancreatic, hematologic, renal, endocrine, cardiovascular and/or mental disease, or who have history of those diseases.
2. Subjects who have a serious injury or surgical history within 12 weeks prior to this study.
3. Subjects who have history of allergic reaction to foods or drugs which needs its treatment or who have possibility of the reaction.
4. Subjects who regularly take foods for specified health uses, foods with function claims and/or supplements, etc. which would affect this study.
5. Subjects who participate in other clinical trials within 4 weeks prior to this study.
6. Subjects who are judged as unsuitable for this study by the principal investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Shoji |
Organization
Otsuma Women's University
Division name
Department of Food Science, Faculty of Home Economics
Zip code
102-8357
Address
12 Sanban-cho,Chiyoda-ku,Tokyo
TEL
0352756086
shoji@otsuma.ac.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Shoji |
Organization
Otsuma Women's University
Division name
Department of Food Science, Faculty of Home Economics
Zip code
102-8357
Address
12 Sanban-cho,Chiyoda-ku,Tokyo
TEL
0352756086
Homepage URL
shoji@otsuma.ac.jp
Sponsor or person
Institute
Otsuma Women's University
Institute
Department
Personal name
Funding Source
Organization
Otsuma Women's University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical review committee of Otsuma Women's University
Address
12 Sanban-cho,Chiyoda-ku,Tokyo
Tel
0352756408
kenkyu.s@ml.otsuma.ac.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 | 07 | Month | 08 | Day |
Related information
URL releasing protocol
Unpublished due to the protocol including the intellectual property rights
Publication of results
Published
Result
URL related to results and publications
works in progress
Number of participants that the trial has enrolled
15
Results
A significant difference was observed in the orimary outcome.
Results date posted
| 2024 | Year | 09 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy adults
Participant flow
15 participants completed and 14 subjects were incorporated into the analyses (1 person Data could not be obtained)
Adverse events
None
Outcome measures
skin temperature
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 21 | Day |
Last follow-up date
| 2022 | Year | 12 | 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 | 07 | Month | 08 | Day |
Last modified on
| 2024 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051160
