UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025798 |
|---|---|
| Receipt number | R000029669 |
| Scientific Title | Randomized, double-blind, crossover, confirmation test of cold sensitivity and blood flow improving function by ingesting test food. |
| Date of disclosure of the study information | 2017/01/23 |
| Last modified on | 2020/10/05 18:11:03 |
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Basic information
Public title
Randomized, double-blind, crossover, confirmation test of cold sensitivity and blood flow improving function by ingesting test food.
Acronym
Randomized, double-blind, crossover, confirmation test of cold sensitivity and blood flow improving function by ingesting test food.
Scientific Title
Randomized, double-blind, crossover, confirmation test of cold sensitivity and blood flow improving function by ingesting test food.
Scientific Title:Acronym
Randomized, double-blind, crossover, confirmation test of cold sensitivity and blood flow improving function by ingesting test food.
Region
| Japan |
Condition
Condition
Females in good health
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm improving function of cold sensitivity and blood flow of test food.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body surface temperature and blood flow after 2 weeks ingestion of test food.
Key secondary outcomes
Blood NOx concentration on 60min after test food ingestion.
Questionnaire after 2 weeks ingestion of test food.
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
Ingesting test food, 2 tablets after completion of morning meal for 2 weeks. After 2 weeks of washout period, ingesting placebo food, 2 tablets in a day for 2 weeks.
Interventions/Control_2
Ingesting test food, 2 tablets after completion of morning meal for 2 weeks. After 2 weeks of washout period, ingesting test food, 2 tablets in a day for 2 weeks.
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
| Not applicable |
Gender
Female
Key inclusion criteria
1) Females aged over 20 years old when obtaining informed consent.
2) Subjects who have subjective symptoms of cold sensitivity.
3) Subjects who show understanding of the study procedures and agreement with participating the study by written informed consent prior to the study.
Key exclusion criteria
1) Subjects who were diagnosed as chilliness by medical doctor.
2) Subjects who ingest medicines and/or supplement regularly for improving fatigue, blood flow, cold sensitivity or stress.
3) Pregnant or possibly pregnant women, or lactating women.
4) Subjects who have previous and/or current medical history of serious disease in heart, liver, kidney and/or digestive trucks.
5) Subjects who excessive alcohol intake.
6) Subjects who have extremely irregular life rhythms, and subjects who have midnight work or irregular shift work.
7) Subjects who have previous medical history of drug and/or food allergy.
8) Subjects who are participating the other clinical tests of medicines or foods. Subjects who participated other clinical tests of medicines or foods within 4-weeks prior to the current study.
9) Subjects who donated over 200mL blood and/or blood components within a month to the current study.
10) Subjects who donated over 400mL blood within the last four months to the current study.
11) Subjects who will be collected over 800mL blood and/or blood components when, the sampling amounts within the last twelve months are adding to the planned sampling amounts of this study.
12) Subjects who have been determined ineligible by principal investigator or sub-investigator.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Katsuhisa |
| Middle name | |
| Last name | Sakano |
Organization
CPCC Company Limited
Division name
Clinical Research Planning Department
Zip code
101-0047
Address
4F Chushin Build. 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047 Japan
TEL
03-5297-3112
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Numa |
Organization
CPCC Company Limited
Division name
Plan Sales Department
Zip code
101-0047
Address
4F Chushin Build. 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047 Japan
TEL
03-5297-3112
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
TAIHO PHARMACEUTICAL 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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
Tel
03-5297-5548
IRB@cpcc.co.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
| 2017 | Year | 01 | Month | 23 | 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
Completed
Date of protocol fixation
| 2016 | Year | 12 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 24 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 23 | Day |
Last modified on
| 2020 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029669
