Unique ID issued by UMIN | UMIN000012938 |
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Receipt number | R000015107 |
Scientific Title | Effectiveness of OS-1 for Water and Electrolyte Supplementation in Sauna-Induced Dehydration. Preventive Effects of Periodic OS-1 Intake |
Date of disclosure of the study information | 2014/01/24 |
Last modified on | 2014/01/24 12:55:03 |
Effectiveness of OS-1 for Water and Electrolyte Supplementation in Sauna-Induced Dehydration.
Preventive Effects of Periodic OS-1 Intake
Effectiveness of OS-1 for Water and Electrolyte Supplementation in Sauna-Induced Dehydration.
Preventive Effects of Periodic OS-1 Intake
Effectiveness of OS-1 for Water and Electrolyte Supplementation in Sauna-Induced Dehydration.
Preventive Effects of Periodic OS-1 Intake
Effectiveness of OS-1 for Water and Electrolyte Supplementation in Sauna-Induced Dehydration.
Preventive Effects of Periodic OS-1 Intake
Japan |
Dehydration
Not applicable |
Others
NO
in the present study the preventive effects of periodic OS-1 for water and electrolyte supplementation in healthy adult men with sauna-induced dehydration was investigated using commercially available mineral water (MW) as a control solution
Efficacy
Exploratory
Explanatory
Not applicable
cumulative urine volume,
blood osmolarity
Serum electrolyte (Na, K, Cl),hemoglobin, hematocrit, serum total protein, serum albumin blood urea nitrogen, serum glucose, water and electrolyte balance (Na, K, Cl) ,FeNa, sweat electorolyte (Na, K, Cl) ,body weight change, body weight change rate
Interventional
Cross-over
Randomized
Individual
Open -no one is blinded
Active
NO
NO
Institution is not considered as adjustment factor.
YES
No need to know
2
Treatment
Food |
OS-1 group (OS-1 is consumed first)
Sequence: OS-1 - wash out - MW
MW group (MW is consumed first)
Sequence: MW - wash out - OS-1
20 | years-old | <= |
Not applicable |
Male
1)male, 20 years of age or older (on the day of informed consent acquisition)
2)body weight between <=50kg and >70kg and body fat 25% or less (The percent of body fat measures it with a commercial body fat calculator)
3) The person that abnormality to become the problem for a study entry by screening examination carried out in an enforcement medical institution is not recognized
1) The person who performed 400mL of whole blood drawing within 12 weeks before examination food intake of stage I
The person who performed 200mL of whole blood drawing within four weeks before examination food intake of stage I
The person who performed apheresis (plasma ingredient or platelet ingredient) within two weeks before examination food intake of stage I
2) Person who participated in medication clinical trial within 12 weeks before examination food intake of stage1
3) the person who sweated a large amount by sauna bathing or an intense movement etc within three days before entering of the medical institution
4) Person who was judged unsuitable as subject of examination by examination doctor
12
1st name | |
Middle name | |
Last name | Hiroshi Iwakiri |
Otsuka pharmaceutical Factory, Inc.
Senior Operating Officer, Director Medical Foods Research Institute
115 Kuguhara, Tateiwa, Muya-cho, Naruto, Tokushima 772-8601, Japan
088-685-1151
ebisug@otsuka.jp
1st name | |
Middle name | |
Last name | Kenichi Inada |
Medical Co. LTA Kyushu Clinical Pharmacology Research Clinic
Planning and Coordination Dept
2-13-16 Jigyo, Chuo-ku, Fukuoka City
092-733-1001
kenichi-inada@lta-med.com
Otsuka pharmaceutical Factory, Inc.
Otsuka pharmaceutical Factory, Inc.
Profit organization
Japan
NO
医療法人相生会 九州臨床薬理クリニック(福岡県)
2014 | Year | 01 | Month | 24 | Day |
Unpublished
Completed
2013 | Year | 10 | Month | 31 | Day |
2013 | Year | 11 | Month | 16 | Day |
2013 | Year | 12 | Month | 11 | Day |
2014 | Year | 01 | Month | 24 | Day |
2014 | Year | 01 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015107
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