UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016001 |
|---|---|
| Receipt number | R000018561 |
| Scientific Title | Effects of dietary and exercise intervention based on AminoIndex Metabolic Screening. |
| Date of disclosure of the study information | 2014/12/20 |
| Last modified on | 2014/12/16 13:39:26 |
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Basic information
Public title
Effects of dietary and exercise intervention based on AminoIndex Metabolic Screening.
Acronym
Effects of dietary and exercise intervention based on ''AIMS''.
Scientific Title
Effects of dietary and exercise intervention based on AminoIndex Metabolic Screening.
Scientific Title:Acronym
Effects of dietary and exercise intervention based on ''AIMS''.
Region
| Japan |
Condition
Condition
potential metabolic syndrome patients
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of dietary and exercise intervention on the AIMS score and related variables regarding lifestyle-related diseases
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The AIMS score, variables regarding lifestyle-related diseases, plasma amino acid concentrations
Key secondary outcomes
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
diet and exercise intervention
Interventions/Control_2
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
A patient corresponded to any of the following;
1.BMI 22<=
2.waist circumference: men 85<=, women 90<=
3.falls into any of the following: diabetes, hypertension, dislipidemia
Key exclusion criteria
none
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Tochikubo |
Organization
Kanagawa Health Service Association
Division name
Chuo-Shinryojo
Zip code
Address
58 Nihon-Odori, Naka-Ku, Yokohama-Shi
TEL
045-641-8501
tochikubo@yobouigaku-kanagawa.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Osamu Tochikubo |
Organization
Kanagawa Health Service Association
Division name
Chuo-Shinryojo
Zip code
Address
58 Nihon-Odori, Naka-Ku, Yokohama-Shi
TEL
045-641-8501
Homepage URL
tochikubo@yobouigaku-kanagawa.or.jp
Sponsor or person
Institute
Kanagawa pref.
Institute
Department
Personal name
Funding Source
Organization
Kanagawa pref.
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
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
| 2014 | Year | 12 | Month | 20 | 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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 10 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 20 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 19 | Day |
Last modified on
| 2014 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018561
