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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000017118
Receipt No. 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

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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
Last 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
Email ykoma@tokyo-med.ac.jp

Public contact
1st 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
Email ykoma@tokyo-med.ac.jp

Sponsor
Institute Tokyo Medical University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019860

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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