UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034450 |
|---|---|
| Receipt number | R000039285 |
| Scientific Title | A study for an effect of the food containing plant-derived ingredient on body temperature and blood vessel function |
| Date of disclosure of the study information | 2018/10/18 |
| Last modified on | 2019/01/07 10:05:31 |
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Basic information
Public title
A study for an effect of the food containing plant-derived ingredient on body temperature and blood vessel function
Acronym
Effect of plant-derived ingredient on body temperature and blood vessel function
Scientific Title
A study for an effect of the food containing plant-derived ingredient on body temperature and blood vessel function
Scientific Title:Acronym
Effect of plant-derived ingredient on body temperature and blood vessel function
Region
| Japan |
Condition
Condition
Nothing (Healthy adults)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of the food containing plant-derived ingredient on body temperature and blood vessel function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body temperature after 21 days repeated ingestion
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Repeated intake active food (product code:A-001) once a day for 21 days.
Interventions/Control_2
Repeated intake placebo food (product code:B-001) once a day for 21 days.
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
| 59 | years-old | >= |
Gender
Male
Key inclusion criteria
1.Healthy men
2.Age>=25 and <60 years
Key exclusion criteria
1.Person who is presence of liver, kidney, and heart disease; respiratory, endocrine, metabolic, nervous system, or cognitive disorders; or diabetes or other diseases.
2.Person who has surgery within 2 months before the trial.
3.Person who has donated over 200 mL blood within one month or over 400 mL blood within three months before the trial.
4.Person who taking medications for hyperglycaemia, lipid metabolism, or hypertension.
5.Person whose SBP is over 160 mmHg or DBP is over 100 mmHg.
6.Person who taking supplements or foods that affect this trial (serum triacylglycerol, blood glucose, blood pressure, serum cholesterol, body fat).
7.Person who changes in body weight of => 3.0 kg within 1 month before the trial.
8.Person who is smoker.
9.Person who has allergies to food.
10.Person who participating or planning to participate in other clinical trial.
11.Person who can't agree informed consent.
12.Person who are judged to be inappropriate for current trial by the supervising physician or principal investigator for other reasons.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichiro Saito |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-7456
saito.shinichiro@kao.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasutoshi Ando |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-3-5630-7476
Homepage URL
andou.yasutoshi@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
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
Address
Tel
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
花王株式会社（東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | Month | 18 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 10 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 10 | Month | 22 | 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
| 2018 | Year | 10 | Month | 11 | Day |
Last modified on
| 2019 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039285
