UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033587 |
|---|---|
| Receipt number | R000038303 |
| Scientific Title | A study of the effect of fluid intake (SIC-2018-04-WKNK) |
| Date of disclosure of the study information | 2018/08/04 |
| Last modified on | 2022/02/02 14:56:08 |
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Basic information
Public title
A study of the effect of fluid intake (SIC-2018-04-WKNK)
Acronym
A study of the effect of fluid intake (SIC-2018-04-WKNK)
Scientific Title
A study of the effect of fluid intake (SIC-2018-04-WKNK)
Scientific Title:Acronym
A study of the effect of fluid intake (SIC-2018-04-WKNK)
Region
| Japan |
Condition
Condition
No applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the effect of fluid intake
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fasting plasma glucose concentration
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Additional water intake for twelve weeks
Interventions/Control_2
No intervention
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
| 50 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) From 50 to 75 years Japanese at the time of consent.
(2) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria
(1) Subjects who are under treatment, medication and life-style advice for diabetes and hypertention by doctors.
(2) Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal, endocrine and metabolic disorders and/or affected with an infectious disease which is required to report to the authorities.
(3) Subjects who experienced unpleasant feeling during drawing blood.
(4) Subjects who have been determined ineligible by principal investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Watanabe |
Organization
Suntory global innovation center limited.
Division name
Research Institute
Zip code
619-0284
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, JAPAN
TEL
050-3182-0593
H_Watanabe@suntory.co.jp
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Nakamura |
Organization
Suntory global innovation center limited.
Division name
Research Institute
Zip code
619-0284
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, JAPAN
TEL
050-3182-2513
Homepage URL
Yumi_Nakamura@suntory.co.jp
Sponsor or person
Institute
Hokkaido Information University
Institute
Department
Personal name
Funding Source
Organization
Suntory global innovation center limited.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the ethics committee of Hokkaido Information University
Address
Nishi Nopporo 59-2 Ebetsu, Hokkaido, 069-8585
Tel
011-385-4411
soumu@do-johodai.ac.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 | 08 | Month | 04 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/32340375/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/32340375/
Number of participants that the trial has enrolled
60
Results
There were no significant changes in fasting blood glucose and arginine vasopressin levels, but systolic blood pressure was significantly decreased in the intervention group. Furthermore, water supplementation increased body temperature, reduced blood urea nitrogen concentration, and suppressed estimated glomerular filtration rate reduction.
Results date posted
| 2022 | Year | 02 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Japanese participants with a fasting blood glucose level from 90-126 mg/dL, aged 50-75, and with normal kidney function with an estimated glomerular filtration rate (eGFR) over 60.
Participant flow
Out of the 174 people recruited, we selected 60 people to participate in the study. However, as two people dropped out of the study after allocation, we conducted the study with 58 subjects in total, 30 subjects in control group and 28 subjects in intervention group. All subjects completed the study. After completion of the study, three subjects were removed from the analysis for influencing the data based on the following reasons: the long-term use of antihypertensive agents and analgesics (n = 2), or asthma symptoms being seen during the study period (n = 1). Finally, statistical analysis was done on 27 subjects in the control group and 28 subjects in the intervention group.
Adverse events
No adverse events due to the intervention were observed in this study.
Outcome measures
The primary outcome was the difference in fasting blood glucose levels from baseline at Weeks 4, 8, and 12 between the control and intervention groups. The secondary outcomes were the differences in physical, hematological, and biological assessments.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 07 | Month | 23 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 04 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 24 | 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 | 08 | Month | 01 | Day |
Last modified on
| 2022 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038303
