UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017118 |
|---|---|
| Receipt number | R000019860 |
| Scientific Title | A randomized, double blind, placebo-controlled trial of zinc and astaxanthin among mild glucose intolerance |
| Date of disclosure of the study information | 2015/04/13 |
| Last modified on | 2016/04/13 10:08:38 |
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Basic information
Public title
A randomized, double blind, placebo-controlled trial of zinc and astaxanthin among mild glucose intolerance
Acronym
A randomized, double blind, placebo-controlled trial of zinc and astaxanthin among mild glucose intolerance
Scientific Title
A randomized, double blind, placebo-controlled trial of zinc and astaxanthin among mild glucose intolerance
Scientific Title:Acronym
A randomized, double blind, placebo-controlled trial of zinc and astaxanthin among mild glucose intolerance
Region
| Japan |
Condition
Condition
mild glucose intolerance
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of taking zinc and astaxanthin on mild glucose intolerance
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c,GA
Key secondary outcomes
AIS,PSQI,CESD,SF8,sleep log
Actigraph
T-C,HDL-C,LDL-C,TG
BUN,s-cre,e-GFR
Zn
Blood pressure
BMI
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
placebo
Interventions/Control_2
zinc
Interventions/Control_3
zinc and astaxanthin
Interventions/Control_4
zinc and astaxanthin
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Level of GA: 15.6%-18.3%
Key exclusion criteria
diabetic disease
current use of substances or medications known to affect sleep, including prescription psychotropics, sedatives, hypnotics
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichi Inoue |
Organization
Tokyo Medical University
Division name
Department of Somnology
Zip code
Address
Shinjuku, Shinjuku-ku, Tokyo
TEL
03-3351-6141
ykoma@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoko Komada |
Organization
Tokyo Medical University
Division name
Department of Somnology
Zip code
Address
Shinjuku, Shinjuku-ku, Tokyo
TEL
03-3351-6141
Homepage URL
ykoma@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Research Project on Development of Agricultural Products and Foods
with Health-promoting benefits (NARO)
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2015 | Year | 04 | Month | 13 | 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
| 2015 | Year | 02 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 02 | 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
| 2015 | Year | 04 | Month | 13 | Day |
Last modified on
| 2016 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019860
