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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
