UMIN-CTR Clinical Trial

Basic information
Public title	An interventional study for activation of human brown adipose tissue
Acronym	An interventional study for activation of human brown adipose tissue
Scientific Title	An interventional study for activation of human brown adipose tissue
Scientific Title:Acronym	An interventional study for activation of human brown adipose tissue
Region	Japan

Condition
Condition	Healthy
Classification by specialty	Endocrinology and Metabolism Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the activation of human brown adipose tissue after the performance of yoga exercises.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	A standardized uptake value of FDG in PET scan before and after the performance of yoga exercises.
Key secondary outcomes

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	Maneuver
Interventions/Control_1	Performance of yoga exercises.
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	25 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Persons who have more than five years-experience of yoga. 2) Persons who is experienced in breathing of yoga for more than 30 minutes. 3) Persons aged from 25 to 65 years old. 4) Persons who consented to participate in the study.
Key exclusion criteria	1) Persons with any of follows; type 2 diabetes, thyroid diseases, malignancy, inflammative disorder, or collagen diseases. 2) Pregnant women.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kazuyuki Tobe
Organization	University of Toyama
Division name	First Department of Internal Medicine
Zip code
Address	2630 sugitani, toyama city
TEL	076-434-7287
Email	tobe@med.u-toyama.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Shiho Fujisaka
Organization	University of Toyama
Division name	First Department of Internal Medicine
Zip code
Address	2630 sugitani, toyama city
TEL	076-434-7287
Homepage URL
Email	shihof@med.u-toyama.ac.jp

Sponsor
Institute	University of Toyama
Institute
Department

Funding Source
Organization	University of Toyama
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

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 25 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
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	Terminated
Date of protocol fixation	2016 Year 01 Month 22 Day
Date of IRB	2016 Year 03 Month 28 Day
Anticipated trial start date	2016 Year 04 Month 25 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2018 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2016 Year 04 Month 25 Day
Last modified on	2020 Year 05 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025389