UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011594
Receipt number R000013219
Scientific Title Effects of dietary intervention on plasma amino acid profiles in diabetes patient
Date of disclosure of the study information 2013/09/01
Last modified on 2013/08/28 08:47:13

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Basic information

Public title

Effects of dietary intervention on plasma amino acid profiles in diabetes patient

Acronym

Effects of dietary intervention on plasma amino acid profiles in diabetes patient

Scientific Title

Effects of dietary intervention on plasma amino acid profiles in diabetes patient

Scientific Title:Acronym

Effects of dietary intervention on plasma amino acid profiles in diabetes patient

Region

Japan


Condition

Condition

Diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the relationship between plasma amino acid patterns and metabolic syndrome-related parameters.
To clarify the effect of dietary intervention on amino acid profiles in plasma.

Basic objectives2

Others

Basic objectives -Others

Relationship between plasma amino acid patterns and metabolic syndrome

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Amino acid concentrations in plasma, metabolic syndrome-related parameters

Key secondary outcomes



Base

Study type


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Simple dietary intervention

Interventions/Control_2

Dietary intervention recommending diets containing high levels of essential amino acids

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


Not applicable

Gender

Male and Female

Key inclusion criteria

People who signed the informed consent to participate in the study
People who can record their meals correctly

Key exclusion criteria

Psychologically ill

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Iseki Keiko

Organization

Iseki clinic

Division name

Iseki clinic

Zip code


Address

Plat Sakuradai, Toyotamagami 2-15-18, Nerima-ku, Tokyo

TEL

03-5912-1500

Email

oubukiseki@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Iseki Keiko

Organization

Iseki clinic

Division name

Iseki clinic

Zip code


Address

Plat Sakuradai, Toyotamagami 2-15-18, Nerima-ku, Tokyo

TEL

03-5912-1500

Homepage URL


Email

oubukiseki@gmail.com


Sponsor or person

Institute

Ajinomoto Co., Inc.

Institute

Department

Personal name



Funding Source

Organization

Ajinomoto Co., Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Link & Communication Inc.

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

井関内科(東京都)


Other administrative information

Date of disclosure of the study information

2013 Year 09 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


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

2011 Year 11 Month 01 Day

Date of IRB


Anticipated trial start date

2012 Year 01 Month 01 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

2013 Year 08 Month 28 Day

Last modified on

2013 Year 08 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013219


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name