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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000038723
Receipt No. R000043942
Scientific Title Effects of soy protein on brown adipose tissue activity
Date of disclosure of the study information 2019/12/01
Last modified on 2019/11/15

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Basic information
Public title Effects of soy protein on brown adipose tissue activity
Acronym Effects of soy protein on brown adipose tissue activity
Scientific Title Effects of soy protein on brown adipose tissue activity
Scientific Title:Acronym Effects of soy protein on brown adipose tissue activity
Region
Japan

Condition
Condition Healthy males
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to evaluate whether soy protein intake modulates circulating peptide hormone level and brown adipose tissue activity in healthy young male subjects.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Effects of soy protein intake for 2 weeks on brown adipose tissue activity
Key secondary outcomes Effects of soy protein intake for 2 weeks on circulating peptide hormone level

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Food
Interventions/Control_1 Two weeks intake of 10 g soy protein per day
Interventions/Control_2 Two weeks intake of placebo.
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria Healthy young subjects over 18 years old
Key exclusion criteria Subject who have chronic diseases
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Hirokazu
Middle name
Last name Taniguchi
Organization Kyoto prefectural university
Division name Graduate school of life and environmental sciences
Zip code 606-8522
Address 1-5 Hangi-cho, Shimogamo, Kyoto
TEL +81-75-703-5415
Email hirokazu-t@kpu.ac.jp

Public contact
Name of contact person
1st name Hirokazu
Middle name
Last name Taniguchi
Organization Kyoto prefectural university
Division name Graduate school of life and environmental sciences
Zip code 606-8522
Address 1-5 Hangi-cho, Shimogamo, Kyoto
TEL +81-75-703-5415
Homepage URL
Email hirokazu-t@kpu.ac.jp

Sponsor
Institute Kyoto prefectural university
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
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 Kyoto prefectural university
Address 1-5 Hangi-cho, Shimogamo, Kyoto
Tel +81-75-703-5147
Email kikaku@kpu.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

Other administrative information
Date of disclosure of the study information
2019 Year 12 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 21
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 No longer recruiting
Date of protocol fixation
2019 Year 04 Month 01 Day
Date of IRB
2019 Year 06 Month 04 Day
Anticipated trial start date
2019 Year 11 Month 06 Day
Last follow-up date
2019 Year 12 Month 16 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 11 Month 29 Day
Last modified on
2019 Year 11 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043942

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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