UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000019364
Receipt No. R000022392
Scientific Title Effect of brown adipose tissue on energy metabolism in human
Date of disclosure of the study information 2015/10/18
Last modified on 2019/08/20 (Ver. 4)

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Basic information
Public title Effect of brown adipose tissue on energy metabolism in human
Acronym BAT on EE
Scientific Title Effect of brown adipose tissue on energy metabolism in human
Scientific Title:Acronym BAT on EE
Region
Japan

Condition
Condition Healthy male volunteers
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effect of activity of brown adipose tissue on energy expenditure and substrate utilization in humans.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Diet-induced thermogenesis (DIT) assessed by respiratory gas analysis and physical activity ratio.
Key secondary outcomes Total energy expenditure, activity-induced thermogenesis, respiratory quotient, fat oxidation assessed by respiratory gas analysis, physical activity ratio and urine nitrogen.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 An activity of brown adipose tissue
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
50 years-old >
Gender Male
Key inclusion criteria 1.BMI >=18.5 and <25kg/m2
2.Age>=20 and <50
3.Subjects who provide informed consent by a document
Key exclusion criteria 1.Subjects who are difficult to participate the study due to dysfunctions of liver, kidney, heart, respiration, endocrine secretion, metabolism, nervous system, consciousness or diabetes, or the other dysfunctions
2.Subjects who take medication for glucose or fat metabolism, or hypertension
3.Subjects have allergy against any food in the test diet
4.Heavy smoker (over 21 cigarettes/d)
5.Subjects who drink a lot of alcohol(more than 30 g/day alcohol)
6.Shift worker
7.Subjects judge as unsuitable for the study by the investigator or medical doctor for other reason
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeho TANAKA
Organization National Insutitute of Health and Nutrition
Division name Department of Nutritional Science
Zip code
Address 1-23-1 Toyama Shinjuku-ku Tokyo 162-8636, Japan
TEL 03-3203-5725
Email tanakas@nih.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masanobu Hibi
Organization Kao Corporation
Division name Health Care Food Research Labs.
Zip code
Address 2-1-3 Bunka Sumida-ku Tokyo
TEL 03-5630-7266
Homepage URL
Email hibi.masanobu@kao.co.jp

Sponsor
Institute National Institute of Health and Nutrition
Institute
Department

Funding Source
Organization Grant-In-Aid for Scientific Research from Ministry of Education, Culture, Sports, Science and Technology of Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Department of Nutrition, School of Nursing and Nutriton, Tenshi College
Kao Corporation
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 花王株式会社(東京都)
LSIクリニック(北海道)
国立国際医療研究センター病院(東京都)

Other administrative information
Date of disclosure of the study information
2015 Year 10 Month 18 Day

Related information
URL releasing protocol https://www.nature.com/articles/ijo2016124
Publication of results Unpublished

Result
URL related to results and publications https://www.nature.com/articles/ijo2016124
Number of participants that the trial has enrolled 21
Results 
Diet induced thermogenisis was significantly higher in the brown adipose tissue (BAT)-positive group. The 24-h respiratory quotient was significantly lower in the BAT-positive group than in the BAT-negative group.
Results date posted
2019 Year 08 Month 20 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2016 Year 07 Month 19 Day
Baseline Characteristics 
healthy male adults
Participant flow 
Participants assessed for eligibility (n=46), Participants enrolled (n=21), Data available for analysis (n=21)
Adverse events 
None
Outcome measures 
DIT, Energy expenditure, respiratory quotient
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2012 Year 12 Month 11 Day
Date of IRB
2013 Year 01 Month 07 Day
Anticipated trial start date
2013 Year 01 Month 15 Day
Last follow-up date
2015 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study

Management information
Registered date
2015 Year 10 Month 15 Day
Last modified on
2019 Year 08 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022392