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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024916
Receipt No. R000028590
Scientific Title A research of the effect of mineral water consumption derived from Nagayu hot spring on prediabetes patients
Date of disclosure of the study information 2016/11/20
Last modified on 2016/11/20

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Basic information
Public title A research of the effect of mineral water consumption derived from Nagayu hot spring on prediabetes patients
Acronym A research of the effect of mineral water consumption on prediabetes patients
Scientific Title A research of the effect of mineral water consumption derived from Nagayu hot spring on prediabetes patients
Scientific Title:Acronym A research of the effect of mineral water consumption on prediabetes patients
Region
Japan

Condition
Condition Prediabetes
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects of mineral water consumption derived from Nagayu hot spring on glycemic condition and/or intestinal environment in prediabetes patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Clinical blood test (HbA1c, glycoalbumin, blood glucose, insulin)
16S metagenome analysis of gut microbiota
Metabolome analysis of intestinal metabolites
Key secondary outcomes Gastrointestinal Symptom Rating Scale (GSRS), Japanese edition
Questionnaire
Body weight
Body Mass Index (BMI)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 (1) Consumption of tap water for 28 days. Consumption of 500 ml of tap water divided into thrice daily (30-60 minutes before breakfast, lunch, and dinner).
(2) Consumption of mineral water that collected from Nagayu hot spring for 28 days. Consumption of 500 ml of mineral water divided into thrice daily (30-60 minutes before breakfast, lunch, and dinner).
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 1) Males and females aged 20 or above.
2) Subjects who live around Nagayu hot spring area.
3) Subjects whose HbA1c (NGSP) values are ranged from 5.6 to 6.4%.
4) Subjects who show understanding of the study procedures and agreement with participating the study by written informed consent prior to the study.
Key exclusion criteria 1) Subjects who frequently consume mineral water that collected from Nagayu hot spring.
2) Subjects who consume medicine daily.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinji Fukuda
Organization Metagen, Inc.
Division name Headquarters
Zip code
Address 246-2 Mizukami, Kakuganji, Tsuruoka, Yamagata, Japan
TEL +81-235-64-0330
Email sfukuda@metagen.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinnosuke Murakami
Organization Metagen, Inc.
Division name Headquarters
Zip code
Address 246-2 Mizukami, Kakuganji, Tsuruoka, Yamagata, Japan
TEL +81-235-64-0330
Homepage URL
Email murakami@metagen.co.jp

Sponsor
Institute Metagen, Inc.
Institute
Department

Funding Source
Organization Japan health and research institute
Onsen medical science research center
Organization
Division
Category of Funding Organization Non profit foundation
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
2016 Year 11 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 Enrolling by invitation
Date of protocol fixation
2016 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 20 Day
Last follow-up date
2017 Year 02 Month 20 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded
2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 11 Month 20 Day
Last modified on
2016 Year 11 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028590

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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