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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000023441
Receipt No. R000027003
Scientific Title Impact on body composition and Sugar metabolism and Lipid metabolism by Diet therapy of BCAA or EPA added diet to patients with obesity type 2 diabetes
Date of disclosure of the study information 2016/08/08
Last modified on 2016/08/02

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Basic information
Public title Impact on body composition and Sugar metabolism and Lipid metabolism by Diet therapy of BCAA or EPA added diet to patients with obesity type 2 diabetes
Acronym Impact on body composition and Sugar metabolism and Lipid metabolism by Diet therapy to patients with obesity type 2 diabetes
Scientific Title Impact on body composition and Sugar metabolism and Lipid metabolism by Diet therapy of BCAA or EPA added diet to patients with obesity type 2 diabetes
Scientific Title:Acronym Impact on body composition and Sugar metabolism and Lipid metabolism by Diet therapy to patients with obesity type 2 diabetes
Region
Japan

Condition
Condition obesity type 2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to examine the effect of BCAA/EPA/DHA supplemented diet on body composition and sugar metabolism,triglyceride value in obesity type 2 diabetic patients
Basic objectives2 Others
Basic objectives -Others BCAA and EPA/DHA supplements are not intended to be utilized as a nutrient in the body is a product which is commercially available is accumulated
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the amount of change in the skeletal muscle by dietary intake BCAA,EPA,BCAA load diet before and after 90 days
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Intake of BCAA,EPA,DHA food intake over a period of 90 days
Interventions/Control_2 Intake of BCAA,placebo food intake over a period of 90 days
Interventions/Control_3 Intake of EPA,DHA food intake over a period of 90 days
Interventions/Control_4 Intake of placebo food intake over a period of 90 days
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
30 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria Patient BMI22kg /m2 or more of obese type 2 diabetes
Key exclusion criteria 1.expectant and nursing mothers
2.ckd classification 3 period or more
3.cirrhosis of the liver
4.chronic pancreatitis (decompensated stage)
5.gastrointestinal disorders
6.there is a history of severe hypoglycemia
7.some of the heart pacemaker implantation
8.some of the contracture
9.if there is a taking of sglt2 inhibitors as drug therapy
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name naoto kubota
Organization The University of Tokyo Hospital
Division name Department of Clinical Nutrition Therapy
Zip code
Address 7-3-1,Hongo,Bunkyo-ku,JAPAN
TEL 03-5800-9447
Email nkubota-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name rie sekine
Organization The University of Tokyo Hospital
Division name Department of Clinical Nutrition Therapy
Zip code
Address 7-3-1,Hongo,Bunkyo-ku,JAPAN
TEL 03-5800-9447
Homepage URL
Email kine-tky@umin.ac.jp

Sponsor
Institute The University of Tokyo Hospital
Institute
Department

Funding Source
Organization The University of Tokyo Hospital
Organization
Division
Category of Funding Organization Other
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 08 Month 08 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
2016 Year 06 Month 06 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 08 Month 02 Day
Last modified on
2016 Year 08 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027003

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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