UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000034184 |
|---|---|
| Receipt number | R000038972 |
| Scientific Title | A investigation of temperature maintenance effect by the intake of a anthocyanin-containing juice in adult male with feeling cold. |
| Date of disclosure of the study information | 2018/09/20 |
| Last modified on | 2020/09/23 13:45:03 |
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Basic information
Public title
A investigation of temperature maintenance effect by the intake of a anthocyanin-containing juice in adult male with feeling cold.
Acronym
A investigation of temperature maintenance effect by the intake of a anthocyanin-containing juice in adult male with feeling cold.
Scientific Title
A investigation of temperature maintenance effect by the intake of a anthocyanin-containing juice in adult male with feeling cold.
Scientific Title:Acronym
A investigation of temperature maintenance effect by the intake of a anthocyanin-containing juice in adult male with feeling cold.
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of temperature maintenance effect by the intake of a anthocyanin-containing juice in adult male with feeling cold.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin surface temperature
Key secondary outcomes
Peripheral blood flow
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
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Oral intake of a anthocyanin medium- containing juice (1 time) - washout period of week - Oral intake of a placebo juice
(1 time) - washout period of week -
Oral intake of a anthocyanin high - containing juice (1 time)
Interventions/Control_2
Oral intake of a anthocyanin high - containing juice (1 time) - washout period of week - Oral intake of a anthocyanin medium- containing juice (1 time) - washout period of week - Oral intake of a placebo juice (1 time)
Interventions/Control_3
Oral intake of a placebo juice (1 time) - washout period of week - Oral intake of a anthocyanin high- containing juice (1 time) - washout period of week - Oral intake of a anthocyanin medium - containing juice (1 time)
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
Male
Key inclusion criteria
(1) Healthy males more than 20 years old.
(2) Subjects who are sensitive to the cold and whose cold diagnosis questionnaire score is more than 4 points.
(3) Subjects whose recovery rate of skin temperature is less than 90% after 10 minutes of cold loading.
(4) Subjects who are obtained consent by document in free will.
Key exclusion criteria
(1)Subjects who have an allergy in connection with this study.
(2) Subjects who have been diagnosed disease with vascular disorder (e.g., arteriosclerosis obliterans, obliterating arteritis, connective tissue disease, diabetes ).
(3) Subjects who are judged as unsuitable for the study based on the results of medical questionnaire.
(4) Subjects who have smoking habit.
(5) Subjects who are regularly taking medicine (e.g., warfarin) which may influence skin surface temperature and blood flow.
(6) Subjects who are taking health food, food for specified health use which may influence skin surface temperature and blood flow more than 3 times per week (e.g., functional food which assume polyphenol derived from ginger or hesperidin as active ingredient) .
(7) Subjects who have taken anthocyanin enriched food more than 3 times per week.
(8) Subjects who are judged as unsuitable for the study based on the results of clinical examination and cardiopulmonary function.
(9) Subjects who have regular medication and a history of serious disease which needed medication treatment.
(10)Subjects who are judged as unsuitable for the study based on the results of physical and clinical examination on before intake.
(11)Subjects who have participated in
other clinical study at the start of this study.
(12)Subjects who are judged as unsuitable for the study by the investigator for other reason.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Aizawa |
Organization
Kagome Co.,Ltd
Division name
Innovation Division
Zip code
329-2762
Address
17,nishitomiyama,nasushiobara-shi,Tochigi
TEL
0287-36-2935
Koichi_Aizawa@kagome.co.jp
Public contact
Name of contact person
| 1st name | Kunihiko |
| Middle name | |
| Last name | Wasaki |
Organization
TTC Co.,Ltd.
Division name
Clinical Research Planning Department
Zip code
150-0021
Address
1-20-2, Ebisunishi, shibuya-ku, Tokyo
TEL
0354593714
Homepage URL
k.wasaki@ttc-tokyo.co.jp
Sponsor or person
Institute
TTC Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Kagome 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
Kensho-kai Institutional Review Board
Address
2-12-16, Tamagawa, Fukushima-ku, Osaka
Tel
06-6882-1130
ethics_board@drc-web.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
| 2018 | Year | 09 | Month | 20 | 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
| 2018 | Year | 09 | Month | 07 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 07 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 21 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 18 | Day |
Last modified on
| 2020 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038972
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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