UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A comparative study in sauna-induced dehydration model of healthy adults to investigate the effect of HS-12S and commercial mineral water on benefit of water-electrolyte supplementation.
Title of the study (Brief title)	A comparative study to investigate the effect of HS-12S and commercial mineral water on benefit of water-electrolyte supplementation.
Region	Japan

Condition
Condition	Dehydrated
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of HS-12S and commercial mineral water on benefit of water-electrolyte supplementation with sauna-induced dehydration model of healthy adults
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	body weight after 1,2,3,4 hour(s) intervention
Key secondary outcomes	Blood tests; hematocrit, hemoglobin, Na, K, Cl, total protein, albumin, blood urea nitrogen, creatinine, glucose, serum osmolality Urine tests; urine volume, urine osmolality, Na, K, Cl, creatinine fractional excretion of sodium, water-electrolyte balance (Na, K, Cl)

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Group HS-12S; 1st phase: Intake HS-12S - washed out, two days or more - 2nd phase: Intake mineral water
Interventions/Control_2	Group MW; 1st phase: Intake mineral water - washed out, two days or more - 2nd phase: Intake HS-12S
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
Key inclusion criteria	1) Healthy male who is able to provide written consent, aged 20 years or older then 2) Person weighing 50kg or over 3) Person between 18.5 and 24.9 of BMI 4) Person whose body fat percentage is 25% or less (measured by commercial scaler) 5) Person who has no abnormality to be enrolled
Key exclusion criteria	1) Person with serious cardio-vascular, hepatic, renal, respiratory, endocrine or metabolic diseases, or who has a medical history of these disorders 2) Person who donated more than 200 mL of blood in the last one month, who donated more than 400 mL of blood in the last three months, and/or who donated blood components in the last two weeks 3) Person was included in other clinical studies in the last four months or who is now included in other clinical studies 4) Person considered not suitable for the study by the investigators
Target sample size	24

Research contact person
Name of lead principal investigator	Kouji Akimoto
Organization	Takeda Pharmaceutical Company Limited
Division name	Research and Development Department
Address	12-10, Nihonbashi 2-chome, Chuo-ku Tokyo 103-8668, Japan
TEL	080-6770-9849
Email	kouji.akimoto@takeda.com

Public contact
Name of contact person	Hiroshi Tsukikawa
Organization	Medical Co. LTA Sugioka Memorial Hospital Clinical Research Center
Division name	Planning and Coordination Dept
Address	3-6-1, Kashiiteriha, Higashi-Ku, Fukuoka 813-0017 Japan
TEL	092-662-3608
Homepage URL
Email	hiroshi-tsukikawa@lta-med.com

Sponsor
Institute	Takeda Pharmaceutical Company Limited
Institute
Department

Funding Source
Organization	Takeda Pharmaceutical Company Limited
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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 02 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 26 Day
Anticipated trial start date	2016 Year 02 Month 17 Day
Last follow-up date	2016 Year 03 Month 01 Day
Date of closure to data entry	2016 Year 04 Month 01 Day
Date trial data considered complete	2016 Year 04 Month 18 Day
Date analysis concluded	2016 Year 05 Month 10 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	The rates of weight gain during the sauna bath and 4 hours after intake of fluids were compared for HS-12S and MW groups. It was observed that the absolute rate in the HS-12S group was significantly lower than that in MW group. Further, compared with the MW group, the HS-12S group showed significant recovery in terms of changes in serum osmolality; serum levels of total protein, total albumin, Na , and Cl; and urenary levels of Cl. Compared to MW, HS-12S was more effective in water-electrolyte supplementation in a sauna-induced dehydration model. We conclude that a hypotonic drink such as HS-12S, which contains sodium and glucose, is beneficial during mild dehydration because of its water-electrolyte supplementation efficacy.
Other related information

Management information
Registered date	2016 Year 02 Month 16 Day
Last modified on	2016 Year 08 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024298