UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023441 |
|---|---|
| Receipt number | 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 | 2024/02/07 12:15:36 |
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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
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
kine-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2016 | Year | 06 | Month | 06 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 05 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 08 | Day |
Date of closure to data entry
| 2018 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 22 | Day |
Date analysis concluded
| 2021 | Year | 12 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 02 | Day |
Last modified on
| 2024 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027003
