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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031255
Receipt No. R000035683
Scientific Title Relationship between brown adipose tissue activity and physiological functions in humans
Date of disclosure of the study information 2018/03/01
Last modified on 2019/06/10

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Basic information
Public title Relationship between brown adipose tissue activity and physiological functions in humans
Acronym Human brown adipose tissue and physiological functions
Scientific Title Relationship between brown adipose tissue activity and physiological functions in humans
Scientific Title:Acronym Human brown adipose tissue and physiological functions
Region
Japan

Condition
Condition Healthy adult volunteers
Classification by specialty
Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To analyze the relationship between brown adipose tissue activity and various physiological parameters including adiposity, metabolic syndrome-related parameters and SNP of target genes.
Basic objectives2 Others
Basic objectives -Others Identification of physiological factors having a significant impact on brown adipose tissue activity
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Brown adipose tissue activity
Metabolic syndrome-related parameters
Adiposity
Key secondary outcomes Single nucleotide polymorphism of target genes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 1)Healthy male and female volunteers
2)Aged 20 years <=
3)Be able to provide written informed consent
Key exclusion criteria with a serious disease
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Mami
Middle name
Last name Matsushita
Organization Tenshi College
Division name Department of Nutrition
Zip code 0650013
Address Higashi-ku, Kita-13 Higashi-3, Sapporo, Japan
TEL 011-741-1051
Email matsushita@tenshi.ac.jp

Public contact
Name of contact person
1st name Mami
Middle name
Last name Matsushita
Organization Tenshi College
Division name Department of Nutrition
Zip code 0650013
Address Higashi-ku, Kita-13 Higashi-3, Sapporo, Japan
TEL 011-741-1051
Homepage URL
Email matsushita@tenshi.ac.jp

Sponsor
Institute Tenshi College, Department of Nutrition
Institute
Department

Funding Source
Organization Grants-In-Aid for Scientific Research from the Ministry of Education, Culture, Sports, Science, and Technology of Japan.
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tenshi College
Address Higashi-ku, Kita-13 Higashi-3, Sapporo, Japan
Tel 011-741-1051
Email horii@tenshi.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 天使大学(北海道) / Tenshi College (Hokkaido)

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 01 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
Brown adipose tissue activity is assessed by FDG-PET/CT for recruited subjects, and its relation to morphological and metabolic syndrome-related parameters including BMI, body fatness, blood pressure, blood glucose, blood triglyceride and blood cholesterol will be analyzed. 
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 No longer recruiting
Date of protocol fixation
2018 Year 01 Month 31 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 15 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information For recruited subjects, their daily life-style and brown fat-related gene polymorphism are examined, and the relation to brown adipose tissue activity will be analyzed.

Management information
Registered date
2018 Year 02 Month 12 Day
Last modified on
2019 Year 06 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035683

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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