UMIN-CTR Clinical Trial

Basic information
Public title	A cross-sectional study for energy metabolism in human.
Acronym	A cross-sectional study for energy metabolism in human.
Scientific Title	A cross-sectional study for energy metabolism in human.
Scientific Title:Acronym	A cross-sectional study for energy metabolism in human.
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

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

Assessment
Primary outcomes	Amount of brown adipose tissue
Key secondary outcomes	Total energy expenditure

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	40 years-old >
Gender	Male
Key inclusion criteria	(1) Males who are 20 <= years old <40. (2) Subject who can come to the facility on the designated day. (3) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria	(1) Subjects whose systolic pressure <90 mmHg. (2) Subjects who donated over 200ml whole blood within 4 weeks. (3) Subjects who donated over 400ml whole blood within 12 weeks. (4) Subjects whose blood was collected more than 1200 mL within the last 12 months when the amount of blood sampling in the current study is added. (5) Subjects who are participating in other clinical studies, or who finished clinical study within 4 weeks. (6) Subjects who are applicable to following items a) Subjects with disease on heart, liver, kidney or other organs complication. b) Subjects with a previous history of disease on circulatory organs. c) The subjects who are contracting diabetes. (7) Subjects who have severe allergic rhinitis. (8) Subjects who are on a diet or have a plan. (9) Subjects who have an unsteady lifestyle because of a working shift or a night shift. (10) Subjects who drink a lot. (11) Smoker (12) Subjects whose BMI is less the 18.5 or over 30.0. (13) Subjects whose systolic pressure >160 mmHg or diastolic pressure >100 mmHg. (14) Subjects who are judged as unsuitable for the study by the result of clinical examination and physical examination. (15) Subjects who are judged as unsuitable for the study by the principal investigator for other reasons.
Target sample size	24

Research contact person
Name of lead principal investigator	1st name Akifumi Middle name Last name Maeda
Organization	Suntory Global Innovation Center Ltd.
Division name	Research Institute
Zip code	619-0284
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL	050-3182-0719
Email	Akifumi_Maeda@suntory.co.jp

Public contact
Name of contact person	1st name Akiko Middle name Last name Tateishi
Organization	Suntory Global Innovation Center Ltd.
Division name	Research Institute
Zip code	619-0284
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL	050-3182-0537
Homepage URL
Email	Akiko_Tateishi@suntory.co.jp

Sponsor
Institute	Suntory Global Innovation Center Ltd.
Institute
Department

Funding Source
Organization	None
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	IRB of Fukuda Clinic
Address	Shin-Osaka brick building 2F, 1-6-1 Miyahara, Yodogawa-ku, Osaka-shi, Osaka
Tel	06-6398-0203
Email	fukudaclinicIRB@gmail.com

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	2021 Year 03 Month 19 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	24
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	2021 Year 02 Month 20 Day
Date of IRB	2021 Year 02 Month 20 Day
Anticipated trial start date	2021 Year 03 Month 31 Day
Last follow-up date	2021 Year 04 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	the effect of brown adipose tissue on energy expenditure

Management information
Registered date	2021 Year 03 Month 16 Day
Last modified on	2022 Year 03 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049822