UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012938
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

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Basic information

Public title

Effectiveness of OS-1 for Water and Electrolyte Supplementation in Sauna-Induced Dehydration.
Preventive Effects of Periodic OS-1 Intake

Acronym

Effectiveness of OS-1 for Water and Electrolyte Supplementation in Sauna-Induced Dehydration.
Preventive Effects of Periodic OS-1 Intake

Scientific Title

Effectiveness of OS-1 for Water and Electrolyte Supplementation in Sauna-Induced Dehydration.
Preventive Effects of Periodic OS-1 Intake

Scientific Title:Acronym

Effectiveness of OS-1 for Water and Electrolyte Supplementation in Sauna-Induced Dehydration.
Preventive Effects of Periodic OS-1 Intake

Region

Japan


Condition

Condition

Dehydration

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

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

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

cumulative urine volume,
blood osmolarity

Key secondary outcomes

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


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

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

OS-1 group (OS-1 is consumed first)
Sequence: OS-1 - wash out - MW

Interventions/Control_2

MW group (MW is consumed first)
Sequence: MW - wash out - OS-1

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)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

Key exclusion criteria

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

Target sample size

12


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroshi Iwakiri

Organization

Otsuka pharmaceutical Factory, Inc.

Division name

Senior Operating Officer, Director Medical Foods Research Institute

Zip code


Address

115 Kuguhara, Tateiwa, Muya-cho, Naruto, Tokushima 772-8601, Japan

TEL

088-685-1151

Email

ebisug@otsuka.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kenichi Inada

Organization

Medical Co. LTA Kyushu Clinical Pharmacology Research Clinic

Division name

Planning and Coordination Dept

Zip code


Address

2-13-16 Jigyo, Chuo-ku, Fukuoka City

TEL

092-733-1001

Homepage URL


Email

kenichi-inada@lta-med.com


Sponsor or person

Institute

Otsuka pharmaceutical Factory, Inc.

Institute

Department

Personal name



Funding Source

Organization

Otsuka pharmaceutical Factory, Inc.

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


Email



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

医療法人相生会 九州臨床薬理クリニック(福岡県)


Other administrative information

Date of disclosure of the study information

2014 Year 01 Month 24 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


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

2013 Year 10 Month 31 Day

Date of IRB


Anticipated trial start date

2013 Year 11 Month 16 Day

Last follow-up date

2013 Year 12 Month 11 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 01 Month 24 Day

Last modified on

2014 Year 01 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015107


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name