UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021059 |
|---|---|
| Receipt number | R000024298 |
| Scientific Title | 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. |
| Date of disclosure of the study information | 2016/02/16 |
| Last modified on | 2016/08/24 18:03:50 |
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Basic information
Public title
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.
Acronym
A comparative study to investigate the effect of HS-12S and commercial mineral water on benefit of water-electrolyte supplementation.
Scientific Title
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.
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Kouji Akimoto |
Organization
Takeda Pharmaceutical Company Limited
Division name
Research and Development Department
Zip code
Address
12-10, Nihonbashi 2-chome, Chuo-ku Tokyo 103-8668, Japan
TEL
080-6770-9849
kouji.akimoto@takeda.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Tsukikawa |
Organization
Medical Co. LTA Sugioka Memorial Hospital Clinical Research Center
Division name
Planning and Coordination Dept
Zip code
Address
3-6-1, Kashiiteriha, Higashi-Ku, Fukuoka 813-0017 Japan
TEL
092-662-3608
Homepage URL
hiroshi-tsukikawa@lta-med.com
Sponsor or person
Institute
Takeda Pharmaceutical Company Limited
Institute
Department
Personal name
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)
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 | 02 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
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.
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
| 2016 | Year | 01 | Month | 26 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024298
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