UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A research of the effect of mineral water consumption derived from Nagayu hot spring on prediabetes patients
Title of the study (Brief title)	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	Shinji Fukuda
Organization	Metagen, Inc.
Division name	Headquarters
Address	246-2 Mizukami, Kakuganji, Tsuruoka, Yamagata, Japan
TEL	+81-235-64-0330
Email	sfukuda@metagen.co.jp

Public contact
Name of contact person	Shinnosuke Murakami
Organization	Metagen, Inc.
Division name	Headquarters
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 11 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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