UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019920 |
|---|---|
| Receipt number | R000022957 |
| Scientific Title | Effect of functional food intake (catechin, capsinoid, or grains of paradise) and/or exercise on human brown adipose tissue |
| Date of disclosure of the study information | 2015/11/24 |
| Last modified on | 2015/12/03 13:11:53 |
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Basic information
Public title
Effect of functional food intake (catechin, capsinoid, or grains of paradise) and/or exercise on human brown adipose tissue
Acronym
The effect of sustained catechin-rich beverage intake on brown adipose tissue
Scientific Title
Effect of functional food intake (catechin, capsinoid, or grains of paradise) and/or exercise on human brown adipose tissue
Scientific Title:Acronym
The effect of sustained catechin-rich beverage intake on brown adipose tissue
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of prolonged catechin-rich beverage intake on BAT density
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in brown adipose tissue density after 12 weeks.
Key secondary outcomes
Body fat
Visceral adipose tissue area
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
Healthy volunteers were given a catechin-rich (540 mg/day) beverage every day for 12 weeks.
Interventions/Control_2
Healthy volunteers were given a placebo beverage every day for 12 weeks.
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
| 18 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. healthy volunteer
2. Age>=18
3. Be able to provide written informed consent
Key exclusion criteria
Subjects who are judge as unsuitable for the study by the investigator or medical doctor for other reason
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takafumi Hamaoka |
Organization
Tokyo Medical University
Division name
Department of Sports Medicine for Health Promotion
Zip code
Address
6-1-1, Shinjuku, Shinjuku-ku, Tokyo
TEL
03-3351-6141
kyp02504@nifty.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takafumi Hamaoka |
Organization
Tokyo Medical University
Division name
Department of Sports Medicine for Health Promotion
Zip code
Address
6-1-1, Shinjuku, Shinjuku-ku, Tokyo
TEL
03-3351-6141
Homepage URL
kyp02504@nifty.com
Sponsor or person
Institute
Graduate School of Sport and Health Science, Ritsumeikan University
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Sport and Health Science, Ritsumeikan University
Organization
Division
Category of Funding Organization
Self funding
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
立命館大学 （滋賀県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2013 | Year | 12 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 10 | 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
| 2015 | Year | 11 | Month | 24 | Day |
Last modified on
| 2015 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022957
