UMIN-CTR Clinical Trial

Basic information
Public title	The effect of test food on urinary electrolyte in adult males: A double blind cross-over pilot study.
Acronym	The effect of test food on urinary electrolyte in adult males: A double blind cross-over pilot study.
Scientific Title	The effect of test food on urinary electrolyte in adult males: A double blind cross-over pilot study.
Scientific Title:Acronym	The effect of test food on urinary electrolyte in adult males: A double blind cross-over pilot study.
Region	Japan

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

Objectives
Narrative objectives1	To examine the effect of test food on urinary electrolyte.
Basic objectives2	Others
Basic objectives -Others	To examine the effect of test food on urinary electrolyte.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Urinary electrolyte and urine volume
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Control food (3 days ingestion) - washout period - Test food (3 days ingestion)
Interventions/Control_2	Test food (3 days ingestion) - washout period - Control food (3 days ingestion)
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	65 years-old >=
Gender	Male
Key inclusion criteria	1) Subjects who are voluntarily giving written informed consent. 2) Adult males aged between 20 and 65. 3) Subjects who can take meals, take urine samples and keep a resting state on the schedule indicated by investigators.
Key exclusion criteria	1) Subjects whose clinical inspection results are outside of the reference range and who are estimated inappropriate to this study by principal investigator. 2) Subjects who have or had disorder in digestive, circulatory or endocrine system and who are estimated inappropriate to this study by principal investigator. 3) Subjects who have food allergy. 4) Subjects who are excess of daily salt intake. 5) Subjects who are estimated inappropriate to participate to this study by principal investigator.
Target sample size	12

Research contact person
Name of lead principal investigator	1st name Shintaro Middle name Last name Ono
Organization	Otsuka Pharmaceutical Co., Ltd
Division name	Saga Nutraceuticals Research Institute
Zip code	842-0195
Address	5006-5 Yoshinogari, Kanzaki, Saga
TEL	0952-52-1522
Email	Ono.Shintaro@otsuka.jp

Public contact
Name of contact person	1st name Shintaro Middle name Last name Ono
Organization	Otsuka Pharmaceutical Co., Ltd
Division name	Saga Nutraceuticals Research Institute
Zip code	842-0195
Address	5006-5 Yoshinogari, Kanzaki, Saga
TEL	0952-52-1522
Homepage URL
Email	Ono.Shintaro@otsuka.jp

Sponsor
Institute	Otsuka Pharmaceutical Co., Ltd
Institute
Department

Funding Source
Organization	Otsuka Pharmaceutical Co., Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Otsuka Pharmaceutical Co., Ltd.
Address	Shinagawa Grand Central Tower, 2-16-4, Konan, Minato -ku, Tokyo
Tel	03-6717-1499
Email	shimizu_se@otsuka.jp

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	大塚製薬株式会社　佐賀栄養製品研究所　（佐賀県）

Other administrative information
Date of disclosure of the study information	2022 Year 11 Month 30 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	2021 Year 08 Month 23 Day
Date of IRB	2021 Year 08 Month 23 Day
Anticipated trial start date	2021 Year 09 Month 02 Day
Last follow-up date	2021 Year 11 Month 16 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 08 Month 27 Day
Last modified on	2021 Year 12 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051699