UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043476 |
|---|---|
| Receipt number | R000049594 |
| Scientific Title | Preliminary study on activation of brown adipose tissue in healthy adults by ingestion of fruit juice |
| Date of disclosure of the study information | 2021/03/05 |
| Last modified on | 2022/03/01 10:49:48 |
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Basic information
Public title
Preliminary study on activation of brown adipose tissue in healthy adults by ingestion of fruit juice
Acronym
Preliminary study on activation of brown adipose tissue in healthy adults by ingestion of fruit juice
Scientific Title
Preliminary study on activation of brown adipose tissue in healthy adults by ingestion of fruit juice
Scientific Title:Acronym
Preliminary study on activation of brown adipose tissue in healthy adults by ingestion of fruit juice
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Preliminary evaluation of the effect on brown adipose tissue function of healthy adults before and after ingestion of fruit juice.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in resting energy expenditure and body temperature around brown adipose tissue after 4 weeks of ingestion
Key secondary outcomes
Changes in body composition
Oxygen consumption
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Healthy volunteers are given juice (100ml/day) every day for 4 weeks.
Interventions/Control_2
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
Male and Female
Key inclusion criteria
Healthy male and female over 20 years old
Key exclusion criteria
1) Subject who have some kind of illness and are being treated with drugs
2) Subjects who regularly use health foods such as supplements
3) Subjects with serious or allergic illness
4) Pregnant woman
5) Subjects who are judge as unsuitable for the study by the investigator
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Ippei |
| Middle name | |
| Last name | Shimizu |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Department of Cardiovascular Biology and Medicine
Zip code
951-8510
Address
1-757 Asahimachidori, Chuo-ku, Niigata
TEL
025-227-2185
ippeishimizu@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Furuuchi |
Organization
Bourbon corporation
Division name
Institutes of Health
Zip code
956-0841
Address
316-2 Higashijima, Akiha-ku, Niigata
TEL
0250-25-1296
Homepage URL
furuuchi-ryo@bourbon.co.jp
Sponsor or person
Institute
Niigata University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
Funding Source
Organization
Bourbon 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
The ethical committees of Niigata University
Address
1-757 Asahimachidori, Chuo-ku, Niigata
Tel
025-227-2625
ethics@adm.niigata-u.ac.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 | 03 | Month | 05 | 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
10
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
| 2020 | Year | 11 | Month | 17 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 04 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 05 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 03 | Month | 01 | Day |
Last modified on
| 2022 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049594
