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

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 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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name