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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019920
Receipt No. 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

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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
Email 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
Email kyp02504@nifty.com

Sponsor
Institute Graduate School of Sport and Health Science, Ritsumeikan University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022957

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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