UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051118 |
|---|---|
| Receipt number | R000058212 |
| Scientific Title | Comparison of changes in physiological indices after intake of hot soup between subjects with and without cold constitution |
| Date of disclosure of the study information | 2023/05/22 |
| Last modified on | 2024/08/30 14:34:19 |
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Basic information
Public title
Comparison of changes in physiological indices after intake of hot soup between subjects with and without cold constitution
Acronym
Comparison of changes in physiological indices after intake of hot soup between subjects with and without cold constitution
Scientific Title
Comparison of changes in physiological indices after intake of hot soup between subjects with and without cold constitution
Scientific Title:Acronym
Comparison of changes in physiological indices after intake of hot soup between subjects with and without cold constitution
Region
| Japan |
Condition
Condition
cold constitution
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether there are differences in changes in body temperature and autonomic nerve activity after a single intake of hot soup between subjects with and without cold constitution.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ear temperature
Skin temperature of finger and toe
Key secondary outcomes
Autonomic nervous activities by heart rate variability power spectral analysis
Heart rate
Thermal sensation by visual analogue scales
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
A single intake of test food - washout (a day or more) - a single intake of water as control
Interventions/Control_2
A single intake of water as control - washout (a day or more) - a single intake of test food
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
| 18 | years-old | <= |
Age-upper limit
| 24 | years-old | >= |
Gender
Female
Key inclusion criteria
Female college students with and without cold constitution
Key exclusion criteria
Subjects whose BMI is more than 25
Smoker
Subjects who have heart disease or metabolic disease
Subjects who have irregular menstrual cycle
Pregnant women
Subjects who have food allergy to wheat, milk, soybean or chicken meat
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Midoh |
Organization
Tokyo Healthcare University
Division name
Division of Medical Nutrition, Faculty of Healthcare
Zip code
154-8568
Address
3-11-3 Setagaya, Setagaya-ku, Tokyo, Japan
TEL
0357993711
n-mido@thcu.ac.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Midoh |
Organization
Tokyo Healthcare University
Division name
Division of Medical Nutrition, Faculty of Healthcare
Zip code
154-8568
Address
3-11-3 Setagaya, Setagaya-ku, Tokyo, Japan
TEL
0357993711
Homepage URL
n-mido@thcu.ac.jp
Sponsor or person
Institute
Tokyo Healthcare University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Healthcare 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
Tokyo Healthcare University
Address
4-1-17 Higashigotanda, Shinagawa-ku, Tokyo, Japan
Tel
0354217655
rinri@thcu.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 | 05 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://www2.aeplan.co.jp/jsnfs2024/contents/program.html
Number of participants that the trial has enrolled
20
Results
The intra-aural temperature was transiently higher than the control after the ingestion of hot soup irrespective of constitutions, and then decreased more than before ingestion only in the cold constitution group irrespective of test foods.
Toe temperature was transiently higher than the control after the ingestion of hot soup irrespective of constitutions, but then there was a tendency for the values between the hot soup ingestion and the control to reverse only in the non-cold constitution group.
Results date posted
| 2024 | Year | 08 | Month | 30 | Day |
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 | 05 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 24 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 29 | Day |
Date of closure to data entry
| 2023 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 02 | Month | 29 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 05 | Month | 22 | Day |
Last modified on
| 2024 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058212
