UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051566 |
|---|---|
| Receipt number | R000058833 |
| Scientific Title | Effects of Continuous Intake of Processed Yuzu Peel Foods on improving Cold Sensitivity |
| Date of disclosure of the study information | 2023/07/10 |
| Last modified on | 2024/01/04 15:43:10 |
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Basic information
Public title
Effects of Continuous Intake of Processed Yuzu Peel Foods on improving Cold Sensitivity
Acronym
Effects of Continuous Intake of Processed Yuzu Peel Foods on improving Cold Sensitivity
Scientific Title
Effects of Continuous Intake of Processed Yuzu Peel Foods on improving Cold Sensitivity
Scientific Title:Acronym
Effects of Continuous Intake of Processed Yuzu Peel Foods on improving Cold Sensitivity
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of continuous intake of processed yuzu peel foods on improving cold sensitivity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
skin surface temperature, blood pressure, pulse, axillary temperature, drum temperature
Key secondary outcomes
Questionnaire survey on cold sensitivity and about blood flow improvement
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Oral ingestion of 10g of test food for 7 days.
Interventions/Control_2
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
| 24 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Individuals who can understand the purpose and contents of this study and can agree to participate in this study by letter
2. Healthy female student
3. Individuals with cold sensitivity
Key exclusion criteria
1. Individuals with citrus allergies or underlying illnesses
2. Individuals with a medical history of Raynaud's phenomenon
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Shunji |
| Middle name | |
| Last name | Mizobuchi |
Organization
Kochi Medical School, Kochi University
Division name
Clinical nursing
Zip code
783-8505
Address
Kohasu, Oko-cho, Nankoku-city, Kochi, Japan
TEL
+81888882138
mizoshun@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Shunji |
| Middle name | |
| Last name | Mizobuchi |
Organization
Kochi University
Division name
Clinical nursing, Kochi Medical School
Zip code
783-8505
Address
Kohasu, Oko-cho, Nankoku-city, Kochi, Japan
TEL
+81888882138
Homepage URL
mizoshun@kochi-u.ac.jp
Sponsor or person
Institute
Kochi University
Institute
Department
Personal name
Funding Source
Organization
Kochi 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
Kochi Medical School, Center for Next Generation Medicine
Address
Kohasu, Oko-cho, Nankoku-city, Kochi, Japan
Tel
+81888802719
im62@kochi-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
| 2023 | Year | 07 | Month | 10 | 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
9
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
Completed
Date of protocol fixation
| 2023 | Year | 07 | Month | 05 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 07 | Month | 10 | Day |
Last modified on
| 2024 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058833
