UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of oral rehydration therapy
Title of the study (Brief title)	Efficacy and safety of oral rehydration therapy
Region	Japan

Condition
Condition	adult volunteer
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the safety and efficacy of jelly as oral rehydration therapy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	free fatty acid
Key secondary outcomes	ketone body 3-methylhistidine blood glucose level blood insulin

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	an intake of jelly
Interventions/Control_2	non intake of jelly
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	40 years-old >=
Gender	Male and Female
Key inclusion criteria	healthy adult
Key exclusion criteria	subject who has a complication and BMI(body mass index) is out of range.Smoking
Target sample size	7

Research contact person
Name of lead principal investigator	Yasuo Tsutsumi
Organization	Tokushima University
Division name	Anesthesiology
Address	3-18-15 Kuramoto,Tokushima, 770-8503,JAPAN
TEL	+81-88-633-7181
Email	tsutsumi@tokushima-u.ac.jp

Public contact
Name of contact person	Yasuo Tsutsumi
Organization	Tokushima University
Division name	Anesthesiology
Address	3-18-15 Kuramoto,Tokushima, 770-8503,JAPAN
TEL	+81-88-633-7181
Homepage URL
Email	tsutsumi@tokushima-u.ac.jp

Sponsor
Institute	Tokushima University
Institute
Department

Funding Source
Organization	department cost
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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 09 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 05 Day
Anticipated trial start date	2017 Year 01 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 09 Month 12 Day
Last modified on	2018 Year 07 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027664