UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045044 |
|---|---|
| Receipt number | R000051374 |
| Scientific Title | A study on the effect of intake of the test food on the transition of body surface temperature -open-label placebo-controlled test- |
| Date of disclosure of the study information | 2021/08/03 |
| Last modified on | 2021/10/07 11:56:47 |
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Basic information
Public title
A study on the effect of intake of the test food on the transition of body surface temperature
-open-label placebo-controlled test-
Acronym
A study on the effect of intake of the test food on the transition of body surface temperature
-open-label placebo-controlled test-
Scientific Title
A study on the effect of intake of the test food on the transition of body surface temperature
-open-label placebo-controlled test-
Scientific Title:Acronym
A study on the effect of intake of the test food on the transition of body surface temperature
-open-label placebo-controlled test-
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to validate the effect of the functional ingredient of test food on the transition of body surface temperature in female aged 25-49.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The transition of body surface temperature
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is 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
Replacement 6g of daily oil intake (recommended oil intake: 14g/day) to MCT oil.
Interventions/Control_2
Intake all of daily oil intake (recommended oil intake: 14g/day) with LCT oil.
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
| 25 | years-old | <= |
Age-upper limit
| 49 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Age: 25 to 49 years old
2. Japanese female
3. Those who are aware of cold body.
4. Those who can receive sufficient explanation of the purpose and content of this study, who have ability to agree with the above explanation, who voluntarily participate in this study after coming to a better understanding, and who can give written informed consent.
Key exclusion criteria
1. Those who has been currently visiting a hospital or treated with any drug or herbal remedy for any disease.
2. On diet / exercise therapy under the guidance of a doctor.
3. Those who have a current or history of serious illness.
4. Those who are currently taking drugs, quasi-drug products, foods, or supplements (except for those who can discontinue taking these materials during the trial period after obtaining informed consent).
5. Those who have a past and current medical history of drugs or food allergy.
6. Those who have an excessive smoking habit (over 21 cigarettes/day).
7. Those who have a habit of excessive drinking alcohol habit (over 60 g/day).
8. Those who are likely to change lifestyle (meal, sleep, motional activity) during test period.
9. Those who are going to overseas travel during test period.
10. Those who are currently pregnant or breastfeeding or those who want to become pregnant during the test period.
11. Those who are currently participating in another clinical trial or who had participated in another clinical trial conducted within a month prior to the submission of an informed consent document.
12. Those who were determined by the investigator to be unsuitable for participation in this clinical trial.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Tominaga |
Organization
integrate co., ltd
Division name
Perception and Behavior Strategy design Division
Zip code
151-0051
Address
1-20-1 Sendagaya Shibuya-ku Tokyo Japan
TEL
03-5771-5514
h.tominaga@itgr.co.jp
Public contact
Name of contact person
| 1st name | Keiichi |
| Middle name | |
| Last name | Horiguchi |
Organization
IMEQRD Co., Ltd
Division name
Sales department
Zip code
104-0061
Address
6-2-1 Ginza Chuo-ku Tokyo Japan
TEL
03-6704-5968
Homepage URL
k-horiguchi@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Non-disclosure
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
Suda Clinic institutional review board
Address
2-8-14, Takadanobaba, Shinjyuku-ku, Tokyo
Tel
03-6704-5968
n-yuzawa@imeqrd.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
| 2021 | Year | 08 | Month | 03 | 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
12
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
| 2021 | Year | 07 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 04 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 02 | Day |
Last modified on
| 2021 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051374
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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