UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024916 |
|---|---|
| Receipt number | 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 19:53:07 |
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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
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
murakami@metagen.co.jp
Sponsor or person
Institute
Metagen, Inc.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028590
