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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034448
Receipt No. R000039280
Scientific Title A research of the effect of mineral water consumption derived from Nagayu hot spring on prediabetes patients: a crossover study
Date of disclosure of the study information 2018/10/11
Last modified on 2019/01/15

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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: a crossover study
Acronym A research of the effect of mineral water consumption derived from Nagayu hot spring on prediabetes patients
Scientific Title A research of the effect of mineral water consumption derived from Nagayu hot spring on prediabetes patients: a crossover study
Scientific Title:Acronym A research of the effect of mineral water consumption derived from Nagayu hot spring 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 and insulin)
Key secondary outcomes - 16S metagenome analysis of gut microbiota
- Metabolome analysis of intestinal metabolites
- Gastrointestinal Symptom Rating Scale (GSRS), Japanese edition
- Questionnaire
- Body weight
- Body Mass Index (BMI)

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Group A: Consumption of control water for 14 days. Consumption of 500 ml of control water divided into thrice daily (30-60 minutes before breakfast, lunch, and dinner)

Group B: Consumption of mineral water that collected from Nagayu hot spring for 14 days. Consumption of 500 ml of mineral water divided into thrice daily (30-60 minutes before breakfast, lunch, and dinner)
Interventions/Control_2 Group A: Consumption of mineral water that collected from Nagayu hot spring for 14 days. Consumption of 500 ml of mineral water divided into thrice daily (30-60 minutes before breakfast, lunch, and dinner)

Group B: Consumption of control water for 14 days. Consumption of 500 ml of control water divided into thrice daily (30-60 minutes before breakfast, lunch, and dinner)
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) Subjects who show understanding of the study procedures and agreement with participating the study by written informed consent prior to the study.
2) Males and females who live in Taketa city.
3) Subjects whose HbA1c (NGSP) values are ranged from 5.6 to 6.4% in principle.
Key exclusion criteria 1) Subjects who frequently consume medicine for diabetes.
2) Subjects who frequently consume mineral water that collected from Nagayu hot spring.
Target sample size 40

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

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

Sponsor
Institute Metabologenomics, Inc.
Institute
Department

Funding Source
Organization Japan health and research institute
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
2018 Year 10 Month 11 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
2018 Year 10 Month 05 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 11 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
2018 Year 10 Month 11 Day
Last modified on
2019 Year 01 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039280

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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