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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043632
Receipt No. R000049822
Scientific Title A cross-sectional study for energy metabolism in human.
Date of disclosure of the study information 2021/03/19
Last modified on 2021/03/18

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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
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 Preinitiation
Date of protocol fixation
2021 Year 02 Month 20 Day
Date of IRB
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
2021 Year 03 Month 18 Day


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

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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