UMIN-CTR Clinical Trial

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
Email	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
Email	Yumi_Nakamura@suntory.co.jp

Sponsor
Institute	Hokkaido Information University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038303