UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028982 |
|---|---|
| Receipt number | R000033163 |
| Scientific Title | A confirmation study of the effect on human basal metabolism by consumption of the food which contains plant extract |
| Date of disclosure of the study information | 2017/09/06 |
| Last modified on | 2020/10/06 09:57:10 |
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Basic information
Public title
A confirmation study of the effect on human basal metabolism by consumption of the food which contains plant extract
Acronym
An effect study of plant extract on human basal metabolism
Scientific Title
A confirmation study of the effect on human basal metabolism by consumption of the food which contains plant extract
Scientific Title:Acronym
An effect study of plant extract on human basal metabolism
Region
| Japan |
Condition
Condition
Healthy male adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effect of consumption of the food that contains plant extract on human basal metabolism.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Basal metabolic rate
Key secondary outcomes
*Heart rate
*Deep body temperature
*Sleep situation
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
Test food consumption, 5 weeks for efficiency evaluation, within 7 weeks for safety evaluation.-Washout 5 to 12 weeks-Control food consumption, 5 weeks for efficiency evaluation, within 7 weeks for safety evaluation.-
Interventions/Control_2
Control food consumption, 5 weeks for efficiency evaluation, within 7 weeks for safety evaluation.--Washout 5 to 12 weeks-Test food consumption, 5 weeks for efficiency evaluation, within 7 weeks for safety evaluation.-
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
| 49 | years-old | >= |
Gender
Male
Key inclusion criteria
1)Healthy males aged 20 to 49 years old.
2)Subjects whose body mass index (BMI) is 19.0 kg/m2 to 29.9kg/m2
3)Subjects whose visceral fat area is less than 100cm2
4)Subjects who have constant life cycle and custom to go to bed until around 1 a.m.
5)Subjects giving written informed consent.
Key exclusion criteria
1)Subjects who have severe disease in liver, kidney, heart, lung, digestive organ, blood, endocrine system and metabolic system.
2)Subjects who are receiving treatment or medication at the giving point of informed consent.
3)Subjects who have a history of allergic reaction or hypersensitivity to drug medicine and food.
4)Subjects who have a smoking habit.
5)Subjects who drink alcohol a lot.
6)Subjects who have midnight work or irregular shift work.
7)Subjects who cannot stay and lodging in the facility four times.
8)Subjects who are concerned about rashes and itching by attaching electrode pad.
9)Subjects who have no response in power spectrum of heart rate variability after stimulation of autonomic nerve system.
10)Subjects who are participating in the other clinical tests. Subjects who participated within 1 month prior to the current study and/or who plan to participate in the other clinical tests.
11)Subjects who have been judged as unsuitable for the study by the principal investigator or sub-investigator.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Kodama |
Organization
MORISHITA JINTAN CO.,LTD.
Division name
Health Care Product Department
Zip code
540-0004
Address
2-40, Tamatsukuri 1-Chome, Chuo-Ku, Osaka-city, Osaka
TEL
072-800-1044
t-kodama@jintan.co.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ichinohe |
Organization
CPCC Company Limited
Division name
Plan Sales Department
Zip code
101-0047
Address
4F Chusin Building, 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
MORISHITA JINTAN 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 Chushin Building, 3-3-5 Uchikanda 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 | 09 | Month | 06 | 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
| 2017 | Year | 08 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 07 | 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 | 09 | Month | 04 | Day |
Last modified on
| 2020 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033163
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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