UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055900 |
|---|---|
| Receipt number | R000063878 |
| Scientific Title | An evaluation of efficacy for blood flow and cold intolerance of test food intake. - A placebo-controlled, randomized, double-blind cross-over clinical trial - |
| Date of disclosure of the study information | 2024/10/22 |
| Last modified on | 2024/10/21 17:28:09 |
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Basic information
Public title
An evaluation of efficacy for blood flow and cold intolerance of test food intake. - A placebo-controlled, randomized, double-blind cross-over clinical trial -
Acronym
An evaluation of efficacy for blood flow and cold intolerance of test food intake.
Scientific Title
An evaluation of efficacy for blood flow and cold intolerance of test food intake. - A placebo-controlled, randomized, double-blind cross-over clinical trial -
Scientific Title:Acronym
An evaluation of efficacy for blood flow and cold intolerance of test food intake.
Region
| Japan |
Condition
Condition
Healthy adult women
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This trial aims to investigate the effect of the test food intake on the blood flow and cold intolerance.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood flow
Key secondary outcomes
Body surface temperature
Questionnaire for subjective evaluation
saturation of percutaneous oxygen
Pulse rate
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Take capsules of test food with cold water once at a visit.
Interventions/Control_2
Take capsules of placebo food with cold water once at a visit.
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
| 30 | years-old | > |
Gender
Female
Key inclusion criteria
1. Age between 20 and 30 years old at the time of informed consent
2. Japanese female
3. Those who received the sufficient explanation for the objective and summary of the trial, voluntarily decided to participate in the trial after understanding the purpose and made the written agreement
Key exclusion criteria
Those who are currently pregnant, breastfeeding or planning to get pregnant during the study period.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Nishio |
Organization
Mie University
Division name
Graduate School of Bioresources
Zip code
514-8507
Address
1577 Kurimamachiyacho, Tsu, Mie 514-8507
TEL
059-231-9612
nishio@bio.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Nishio |
Organization
Mie University
Division name
Graduate School of Bioresources
Zip code
514-8507
Address
1577 Kurimamachiyacho, Tsu, Mie 514-8507
TEL
059-231-9612
Homepage URL
nishio@bio.mie-u.ac.jp
Sponsor or person
Institute
Mie University
Institute
Department
Personal name
Funding Source
Organization
Taiyo Kagaku 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
Mie University Ethics review committee
Address
1577 Kurimamachiyacho, Tsu, Mie
Tel
059-232-1211
bio-somu@ab.mie-u.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
| 2024 | Year | 10 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2024 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 10 | Month | 22 | Day |
Last follow-up date
| 2026 | Year | 03 | 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
| 2024 | Year | 10 | Month | 21 | Day |
Last modified on
| 2024 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063878
