UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034448 |
|---|---|
| Receipt number | 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 | 2019/10/29 13:40:55 |
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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 | Shinji |
| Middle name | |
| Last name | Fukuda |
Organization
Metabologenomics, Inc.
Division name
Headquarters
Zip code
997-0052
Address
246-2 Mizukami, Kakuganji, Tsuruoka, Yamagata, Japan
TEL
+81-235-64-0330
research@metagen.co.jp
Public contact
Name of contact person
| 1st name | Shinnosuke |
| Middle name | |
| Last name | Murakami |
Organization
Metabologenomics, Inc.
Division name
Headquarters
Zip code
997-0052
Address
246-2 Mizukami, Kakuganji, Tsuruoka, Yamagata, Japan
TEL
+81-235-64-0330
Homepage URL
research@metagen.co.jp
Sponsor or person
Institute
Metabologenomics, Inc.
Institute
Department
Personal name
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
Japan Health & Research Institute
Address
Garo Building 8F, 3-1-4, Nihonbashi, Chuo-ku, Tokyo, Japan
Tel
03-5290-1621
info@jph-ri.or.jp
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
30
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
Completed
Date of protocol fixation
| 2018 | Year | 10 | Month | 05 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 11 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 10 | Day |
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 | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039280
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| Registered date | File name |
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